Category Archives: General Treatment Issues

Radiation Therapy for Ductal Carcinoma In Situ (DCIS)

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund.


In recent years, ductal carcinoma in situ (DCIS) has become one of the most commonly diagnosed breast conditions. It is often referred to as “stage zero breast cancer” or a “pre-cancer.” It is a non-invasive breast condition that is usually diagnosed on a mammogram when it is so small that it has not formed a lump. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but the abnormality has not spread to other breast cells.

DCIS is not painful or dangerous, but it sometimes develops into breast cancer in the future if it is not treated. If it develops into breast cancer, it can spread.  If that happens, it is called invasive breast cancer. The goal of treating invasive cancer is to prevent it from spreading to the lungs, bones, brain, or other parts of the body, where it can be fatal. Since DCIS is not an invasive cancer, it is even less of a threat than Stage 1 or Stage 2 breast cancer, which are the earliest types of invasive cancer.[1]  For more information, see our free DCIS booklet, and our other articles on DCIS.

Most women with DCIS will never develop invasive cancer whether they are treated or not.  Unfortunately, it is impossible to predict which women with DCIS will develop cancer and which ones won’t. That’s why treatment is recommended. A woman with DCIS does not need all the same treatments as a woman diagnosed with invasive breast cancer, but surgery is almost always recommended. Most DCIS patients will choose a lumpectomy (which removes the DCIS but does not remove the entire breast), and radiation therapy is usually recommended for those women to destroy any stray abnormal cells in the same breast.[1]

Is Radiation Necessary?

Doctors usually recommend radiation therapy for lumpectomy patients, but since it is inconvenient and has some side effects, many women prefer to avoid it.  In fact, some DCIS patients decide to have a mastectomy because they do not want to undergo radiation.  However, mastectomy is a much more radical surgery and is very rarely a good idea for DCIS patients. That’s because almost all women with DCIS live long lives, and undergoing radiation does not affect whether DCIS patients live a long life or not.

Instead, the main advantage of radiation for DCIS is to prevent recurrence of DCIS in the breast where the DCIS was removed. A study of more than 1,700 women with DCIS who underwent a lumpectomy evaluated different treatment options.  The women were randomly assigned either to radiation, tamoxifen, radiation plus tamoxifen, or no treatment after surgery.  Undergoing radiation had a very small benefit for women in general, and has little impact on your chances of living a cancer-free life.

In women treated with radiation, about 10% developed DCIS or breast cancer within the next 10 years after surgery, and it made no difference whether these women took tamoxifen or not. And while the vast majority of women were alive 10 years later, their chances of survival were no different whether they were treated with radiation, tamoxifen, both, or neither.[4]  

For women who did not have radiation therapy, tamoxifen reduced the chances of developing DCIS within 10 years in the same breast by about 3% and the chances of developing DCIS in the other breast by about 1%. Tamoxifen did not significantly decrease the chances of developing invasive breast cancer in the same breast, and only reduced the chances of developing invasive cancer in the opposite breast by about 1%.[4]

So why do doctors so strongly recommend radiation and hormone therapy for DCIS?  Doctors tend to focus on reducing “relative risk” rather than actual risk. So, if a  treatment decreases the chances of recurrence by about 50% that sounds impressive — but 50% of a 16% chance is 8%, for example, and that isn’t much of a difference. And 50% of a 6% chance of recurrence is even less meaningful.  Most important, it doesn’t affect survival so women can skip radiation now and choose it later if they have a recurrence. In contrast, if a woman has radiation after a lumpectomy and later has a recurrence anyway, she can’t undergo radiation again.

When is radiation most important for DCIS?  It is more likely to benefit younger women (especially women diagnosed before age 40), women with more serious types of DCIS (a high grade DCIS called comedo), and women with a family history of breast cancer.

What is the benefit of hormone therapy for women also undergoing radiation therapy?

Tamoxifen blocks the effects of estrogen on breast cells, which can stop the growth of cancer cells that are sensitive to estrogen. A study of more than 1,800 pre-menopausal and post-menopausal women with DCIS evaluated the benefits of tamoxifen for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen for 5 years or a placebo (sugar pill). The study found that after 5 years, women who took tamoxifen were about 5% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread.  The difference was 8 of women taking tamoxifen compared to 13% of women taking placebo. However, the vast majority of women survived and they did not live any longer whether they took tamoxifen or not.[1]

For postmenopausal women, aromatase inhibitors may be used instead of tamoxifen. Aromatase inhibitors block the body’s ability to make estrogen. A study of more than 3,000 post-menopausal women with DCIS evaluated the benefits of hormone treatment for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen or anastrozole for 5 years. The study found that after 5 years, compared to women taking tamoxifen, the women taking anastrozole were 2% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread.  The difference was about 8% of women taking tamoxifen compared to 6% taking anastrozole.  As in the previous study, the vast majority of women survived and those taking anastrozole did not live any longer than women taking tamoxifen.[2]

That was a very small benefit for anastrozole compared to tamoxifen, and another study of post-menopausal women with DCIS found no difference between the two hormone treatments.[3].

Bottom Line:  Radiation and hormone therapy both have benefits for most women who undergo lumpectomy, because they decrease the chances of DCIS returning after surgery.  However, the benefits are quite modest and neither of these treatments affect how long women live, because almost all women diagnosed with DCIS are still alive 20 years later.

References:

  1. National Cancer Institute. Breast Cancer Treatment PDQ. (Feb. 2018). Available online: https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/_1576_toc
  2. Margolese, Richard G et al. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.The Lancet. 2016;387(10021): 849 – 856.
  3. Forbes, John F et al. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. The Lancet.2016;387(10021): 866 – 873.
  4. Cuzick, Jack et al. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. The Lancet Oncology. 2011; 12(1): 21 – 29

Which Breast Implants are Safest for Mastectomy Patients?

Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events

Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.

Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.

The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.

The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.

Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients.  The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.

Copies of the entire book chapter are available upon request at info@center4research.org

Could a Common and Inexpensive Heart Medicine (Beta-Blockers) Help Cancer Patients Live Longer?

Jessica Cote, Cancer Prevention & Treatment Fund

Beta-blockers are drugs that are usually prescribed for high blood pressure (hypertension), irregularities in heart beat (arrhythmias), and to prevent heart attacks after a first heart attack has already occurred. Beta-blockers work by stopping adrenaline and noradrenaline from triggering the body’s “fight or flight” response to stress or danger.  Beta blockers help the body feel more relaxed, lowering blood pressure and increasing blood flow.

Beta-blockers are taken by so many Americans that they are the fifth most widely prescribed class of drugs.[1]  Since they are safe and inexpensive, wouldn’t it be great if they were effective for treating cancer, too?

Doctors and researchers noticed that when cancer patients took beta-blockers because of their heart disease, they tended to live longer than other cancer patients. They decided to study whether beta-blockers significantly improve survival for several different types of cancer.

How Beta-Blockers Affect Different Types of Cancer

Non-Small Cell Lung Cancer

In a study published in Annals of Oncology in 2013, Hong-Mei Wang and colleagues at the MD Anderson Center in Texas reviewed data from 722 patients with non-small cell lung cancer, the most common type of lung cancer.[2] All patients received radiation therapy to treat their lung cancer, but only some took beta-blockers for heart conditions. Almost all the patients in the study had stage III cancer.

The 155 patients taking beta-blockers survived for an average of almost 24 months while the 567 patients not taking beta-blockers survived for an average of about 18.5 months. In addition to living longer, patients taking beta-blockers lived longer without their lung cancer returning (disease-free survival) and without it spreading to other parts of their body (distant metastasis-free survival). The researchers statistically controlled for other factors that could affect survival, such as the patient’s age, the stage of the cancer, the use of aspirin, and use of chemotherapy, to be sure that the beta-blockers were truly helping slow down the cancer.

Breast Cancer

Six studies published since 2010 have examined how beta-blockers affected breast cancer patients who had been treated with beta blockers for heart disease at the same time they were treated for cancer.[3] All six studies found that breast cancer patients lived longer if they were taking beta-blockers.

A new clinical trial is currently underway to find out what happens to women who take beta-blockers specifically as a breast cancer treatment. However, the results are not yet available.

Ovarian Cancer

Elena Diaz and colleagues at Cedars-Sinai Medical Center published a study in 2012 of 248 women who were treated with surgery and chemotherapy for their ovarian cancer.[4] Twenty-three patients took beta-blockers for high blood pressure or other heart conditions during their cancer treatment. The results showed that women who took beta-blockers were more likely to remain free of ovarian cancer after treatment than women who didn’t take beta-blockers (progression-free survival) and less likely to die from ovarian cancer (disease-specific survival). Women taking beta-blocker lived an average of 56 months after cancer treatment while those not taking beta blocker lived an average of 48 months after treatment. In addition, women who took beta-blockers were 54% less likely to die during the more than 12 years that researchers tracked their health, compared to the women who did not take beta blockers.

Pancreatic Cancer

Hussein Al-Wadei and colleagues at the University of Tennessee published a study in 2009 that showed how beta-blockers were able to halt the progression of pancreatic cancer in animals.[5]  Research is needed to determine if beta-blockers is effective for pancreatic cancer in humans.

Why Might Beta-Blockers Help Cancer Patients?

Adrenaline and noradrenaline, the two neurotransmitters that stimulate the “fight or flight” response, probably trigger tumor growth. When beta-blockers halt the activity of these neurotransmitters, they may therefore help reduce the growth of cancerous tumors.

When the FDA makes a decision to approve a drug, it is always for specific symptoms or diseases, and the risks and benefits for that specific treatment is what the FDA considers. Although generally safe, beta-blockers can cause fatigue, headache, upset stomach, constipation, diarrhea, dizziness, cold hands, shortness of breath, and trouble sleeping.   For that reason, it is not a good idea to use beta-blockers to treat cancer unless there is clear evidence that they are likely to work — that the benefits outweigh those risks.  And, that is the reason that the breast cancer study that is now underway only includes beta blockers for 2 days before and 3 days after the cancer surgery.

In addition to being approved by the FDA to control blood pressure and heart disease, beta-blockers are also approved for preventing migraines, treating essential tremor (ET) in the head, arms and legs, and, as eye drops to treat glaucoma.  Doctors prescribe beta blockers for other reasons , but  taking medicines for non-approved uses can be risky. If a use is not approved, it often means that there is no conclusive evidence showing that the benefits outweigh the risks.  However, it sometimes means that the companies making the drug don’t think FDA approval for the new use will benefit the company financially.  The latter is especially true for drugs that are already on the market and inexpensive, such as beta-blockers.

The Bottom Line

  • Beta-blockers are usually used to treat heart conditions like high blood pressure and an irregular heart beat. New research has shown that these inexpensive drugs may help cancer patients live longer.
  • More research is needed to know which beta-blockers work best when added to cancer surgery, radiation, or chemotherapy, and for which cancers.
  • If you already take beta-blockers for a heart condition, they may provide keep taking them if you are also diagnosed with cancer. If you don’t take beta-blockers but are diagnosed with non-small cell lung cancer or early breast cancer, you may want to ask your doctor whether to take beta-blockers for two days before and three days after your cancer surgery.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Consumer Reports, Best Buy Drugs: “Using Beta-blockers to treat: High Blood Pressure and Heart Disease.” Updated March 2011. https://www.consumerreports.org/health/resources/pdf/best-buy-drugs/CU-Betablockers-FIN060109.pdf
  2. Wang HM, Liao ZX, Komaki R et al. Improved survival outcomes with the incidental use of beta-blockers among patients with non-small-cell lung cancer treated with definitive radiation therapy. Annals of Oncology 2013.
  3. Barron TI, Sharp L, Visvanathan K. Beta-adrenergic blocking drugs in breast cancer: a perspective review. Therapeutic Advances in Medical Oncology 2012; 4(3):113-125.
  4. Diaz ES, Karlan BY, Andrew JL. Impact of beta blockers on epithelial ovarian cancer survival. Gynecologic Oncology 2012; 127(2):375-378.
  5. Al-Wadei HAN, Al-Wadei  MH, Schuller HM. Prevention of pancreatic cancer by the beta-blocker propranolol. Anticancer Drugs 2009; 20(6):477-482.

The Benefits of Exercise After Getting Diagnosed with Cancer

Morgan Wharton, Cancer Prevention and Treatment Fund

You may have heard that regular exercise can reduce your risk of developing cancer, but did you know it’s also good for cancer patients who are undergoing or have completed treatment?

Is Exercise Good for Everyone Diagnosed with Cancer?

Exercise has proven benefits for cancer patients, ranging from improved fitness and higher quality of life to reduced rates of recurrence and a longer life.1 2 3 4 5 6 7 8 9 What we know about exercise and cancer mostly comes from studying patients with breast or colon cancer, but there’s reason to believe that there are benefits of exercise for men and women suffering from all types of cancer, even cancer as advanced as Stage III.37

The best news of all: It doesn’t matter if you were fit before you got diagnosed. Whether or not you exercised before has no bearing on what exercise can do for you during and after treatment.346 So, it’s never too late to use exercise to fight cancer. If you’re coping with cancer or its aftermath, now is the time.

What Does the Science Show about Exercise for Cancer Patients?

Many studies have shown that exercise is beneficial to cancer patients, but no one is sure exactly why. Earlier studies suggested that exercise may help women avoid breast cancer or a recurrence of it by decreasing female hormones that feed cancer in the breast10 11, or by lowering inflammation in the body12, a suspected contributor to many diseases. In 2014, a study was published that provides a new possible explanation for how exercise helps the body fight cancer.13 Researchers looked at irisin, a protein released from muscles after exercise, to see how it would affect breast cancer cells and healthy breast cells in test tubes. What they found was that when breast cancer cells came into contact with irisin, they started to self-destruct in a programmed way. While the exercise protein reduced the number of malignant cells and their ability to move around, it left the healthy cells unharmed! The researchers also found that irisin made Doxorubicin, a chemotherapy drug commonly given to breast cancer patients, more effective at killing cancer cells. Though this study did not look at what happens to cancer cells in actual patients after they exercise, it could help explain why other studies have found that cancer patients who are physically active feel better during treatment and are less likely to have their cancer come back.

Studies that did look at patients focused on those beginning exercise (such as walking or aerobic exercise with weight training) somewhere between 2 weeks and 1 year after completing cancer treatment. In these studies, treatment could include surgery, chemotherapy, radiation, or a combination of these therapies.1234678 Some studies also examined the effects of exercise during cancer treatment.59

Less Body Fat and Better Immune System:

Studies have shown that in cancer patients, exercise during or after treatment reduces fat and improves body mass index (BMI).269 Exercise lowers blood pressure, boosts the immune system, and increases bone mineral density.689 Denser bones means fewer fractures.

Improved Fitness:

As expected, cancer patients who exercise regularly during and after treatment reported increases in strength, walking ability, aerobic capacity, and flexibility.269

Less Fatigue and Fewer Side Effects from Treatment:

Cancer patients who had completed treatment reported fewer negative side effects from treatment once they began to exercise regularly.7 Patients who exercised during treatment reported less nausea and less difficulty sleeping.9 The most commonly reported improvement was reduced fatigue. 689

Better Quality of Life:

In addition to the physical health benefits of exercise, cancer patients who exercised also reported improved mental and emotional well-being.2 Patients who exercised during treatment and those who began to exercise afterwards frequently reported an increase in quality of life.9 Patients who began to exercise regularly after treatment experienced less anxiety and a renewed “fighting spirit.”9 Cancer patients over the age of 80 who exercised regularly during their weeks or months of treatment reported less loss of memory.5

Reduced Risk of the Cancer Coming Back:

Because exercise improves the immune system, cancer patients who exercise regularly lower their risk of the cancer returning.1238Patients who exercise are less likely to die from cancer and are more likely to live longer than patients who don’t exercise.14

What Kind of Exercise Should I Do?

Aerobic activity of light to moderate intensity was the most common type of exercise in the studies of cancer patients.23689 Combining aerobic exercise with walking and resistance training (such as weight lifting or using resistance bands) led to greater health benefits than aerobic activity alone.268 

Most studies used Metabolic Equivalent (MET) hours to measure physical activity by level of intensity. MET hours measure the energy output of various activities compared to the energy used by the body when at rest. Activities that require more effort have a higher MET score than activities with lower intensities. One study suggested that 18-27 MET hours per week represents the ideal rate of exercise, because that group showed the lowest rate of recurrence and more activity did not lead to increased benefits.7 Having a MET score comparable to 6 or more hours of walking in a week showed a 47% higher chance of survival without recurrence.3 Click here for a chart of various activities and their MET hour equivalent, so you can calculate your weekly exercise in MET hours and maximize your benefits from exercise.

Walking can improve the health of cancer patients. Studies estimate that the greatest benefit from walking is seen in patients who walk at an average speed(a 20 minute mile) for 3-5 hours weekly.7 Patients who walked just 1 hour per week, regardless of walking speed, showed improvements over the group of patients who reported no physical activity in a week.7

To get the most out exercise, you need to make it a habit—something you commit to for the long-term. That’s why it is better to start small, with easily achievable changes like using the stairs regularly instead of the elevator or walking each evening after dinner. Remember not to set unrealistic goals, because it is better to start small and keep it up than to try to do too much and give up. Don’t miss the chance to get at least some benefit from this easy, free strategy to fight cancer.

The bottom line

Exercise helps individuals who are undergoing cancer treatment and those who have completed cancer treatment. Cancer patients who exercise regularly during and after treatment can expect fewer side-effects from treatment, less fatigue, and better overall fitness and health. Patients who exercise are less likely to experience a return of cancer in the future and are more likely to live longer, healthier lives.

You should try to walk at least six hours a week at an average pace (about 1 mile per 20 minutes).

Even minimum exercise, like walking one hour per week, can improve the health of cancer patients who have completed treatment, compared to cancer patients who do not exercise at all.The benefits from exercise can be seen in all cancer patients, regardless of whether or not they exercised regularly before they were diagnosed with cancer. It’s never too late to begin to exercise and improve your health!

Do cancer researchers make new treatments sound better than they really are?

By Diana Zuckerman, Ph.D. and Jennifer Focht
Updated 2015

Everyone wants to find a cure for cancer, but some medical researchers are exaggerating the effectiveness of the treatments they study. In some cases, information about side effects and other risks are downplayed as well.

To find out if a treatment works, medical researchers compare patients who take the treatment to patients who take a different treatment, or take no treatment at all. The outcome that matters to patients is whether the treatment will cure them or at least help them live longer, with a better quality of life.

That isn’t always the outcome that scientists study, however. For example, a company may instead want to measure whether the treatment successfully got rid of cancer cells or slowed down the progression of cancer. These kinds of measures are called “surrogate endpoints” or “biomarkers” because they substitute for the outcome that really matters (health and survival) by evaluating things that can be studied more quickly and easily and are expected to be related to health and survival – but might not be. Unfortunately, in their desire to get more cancer treatments to market more quickly, many cancer drugs are approved by the FDA based on these preliminary kinds of findings, rather than based on improved health or survival. It may take years or even decades to find out if the new drugs really save lives or improve the quality of patients’ lives. Research published in 2015 indicates that the studies done after recent cancer drugs were approved were more likely to show they don’t save lives or improve health than to show that they do.14

For these and other reasons, published studies of cancer treatment can be misleading.

In addition to FDA lowering the standards for cancer drugs, there are other reasons why doctors and patients may not have all the information they need to help patients make the best treatment decisions. For example, medical journals prefer to publish articles about treatments that are effective, instead of treatments that are not. New, effective treatments are more exciting, but for patients, knowing which drugs don’t work well is just as important as knowing which ones are effective. If researchers learn that a treatment doesn’t actually work, they may have a very hard time getting the results published. And, if the research was funded by the company that makes the treatment, as it usually is, that company will probably not want the study to be published.

Even when researchers sincerely want to publish their study results to help patients, they may find that being completely honest about unimpressive or ambiguous results means they won’t get the study published. Publications are important to scientists, so what can they do to improve their chances of getting the study published in a major medical journal? Those researchers might find it easier to get the article published if they focus on the positive results (such as slowing down the spread of cancer) and ignore the negative results (for example, if the patients did not live longer because the toxic effects of the treatment caused them to die anyway).

Dr. Francisco Emilio Vera-Badillo and his colleagues at the University of Toronto reviewed published articles on breast cancer treatments and found that one out of three misrepresented a treatment’s overall ineffectiveness by highlighting some other benefit. For example, a study might show that patients’ quality of life improved slightly when they started the treatment in question. Feeling better is important, even if only for a short time – but it is a subjective measure that could be influenced by feeling hopeful about getting a new medication. If the purpose of the study was to determine whether or not the treatment helped patients live longer, or at least had a major health benefit from the treatment, then this secondary benefit that a few of the patients felt a little better is just that: secondary. Can a treatment be considered “effective” if it doesn’t do what it is supposed to do?  Is it worth the potential risks to one’s health (most cancer drugs are highly toxic) and the costs (which may be tens of thousands of dollars) to take a drug that isn’t really effective? If the benefits of the new drug are very modest, there may be other, less dangerous and less expensive strategies that could help patients much more. And, even more important, in the same analysis, two out of three of the published articles described the results of their research in a way that glossed over negative side effects, especially when the treatment was effective.15 But negative side effects can be very harmful, or even deadly, so it is important that they be accurate reported.

A separate review of published articles on a variety of health treatments—not just cancer treatments—showed that 16% reported no data about side effects. In nearly one-third of the articles, information on side effects was reported inadequately.16 For example, when researchers found an increased risk of heart attack associated with the arthritis drug Vioxx, they changed the reported time frame of their study when they wrote up their results.17 As a result, the published article did not mention the participants who had experienced heart attacks during the last month of the trial and Vioxx seemed safer than it actually was. (When these risks became known, Vioxx was recalled in 2004.)

Bottom line:

Information about a drug’s effectiveness and side effects are both important, and both should be reported in studies so that patients and their doctors have a full understanding of treatment options. In many areas of medicine, research tends to over-emphasize effectiveness and down-play side effects, and for cancer drugs this tendency may be even more pronounced. Many cancer researchers are calling for stricter guidelines, like standardizing reporting of results to make it more obvious when information is missing, but that will only address part of the problem.

In the meantime, what can you do to ensure the safety of the treatment you are receiving? If you have just been diagnosed with cancer, you may want to consider an older treatment over a newer one. Why? Because newer drugs are often approved on preliminary evidence and wishful thinking, and too often years pass before the true risks and benefits are known. In most cases, newer treatments haven’t been researched as thoroughly as older ones that have been sold for many years. If your doctor wants you to switch to a newer treatment, ask him or her to review each of the side effects with you and compare them to the side effects of your old treatment. If after starting a new treatment, you notice side effects—expected or unexpected—let your doctor know right away. Ask as many questions about your treatment as you want. There are no stupid questions—only stupid answers. You have the right to complete information on your treatment’s effectiveness and risks.

For information on the influence of industry funding on medical research, click here.

Chemotherapy: What is it, and How is it Used?

Austin Van Grack, Cancer Prevention and Treatment Fund

Types of chemotherapy:

Curative chemotherapy
Adjuvant chemotherapy
Neo-adjuvant chemotherapy
Palliative chemotherapy
Maintenance chemotherapy

Patient concerns about chemotherapy:

Patient misunderstandings about chemotherapy
Why are patients confused about chemotherapy?
Health literacy and informed decision making about cancer treatments

Chemotherapy is one of the most common cancer treatments used today. However, 1 in 4 patients receiving chemotherapy do not understand why they’re getting it and how it’s supposed to help them.[1]

Chemotherapy is a cancer treatment that uses one or more drugs to kill cancer cells. It stops or slows the growth of cancer cells, which otherwise may grow quickly.[2]

Types of Chemotherapy

Sometimes the aim of chemotherapy is to get rid of or cure the cancer, but other times the goal is to help somebody with incurable cancer live longer or get relief from some of their cancer symptoms. While there are many different drugs used in chemotherapy (alone or in combinations), there are only five types or uses for chemotherapy. You may hear your doctor use one or more of these terms when talking about your chemotherapy:

  • Curative chemotherapy
  • Adjuvant chemotherapy
  • Neo-adjuvant chemotherapy
  • Palliative chemotherapy
  • Maintenance chemotherapy

Curative Chemotherapy

Curative chemotherapy aims to “cure the cancer,” meaning it is intended to eliminate all cancerous cells, resulting in what doctors call “complete remission.” The majority of patients receiving chemotherapy with the goal of cure are receiving chemotherapy as well as surgery or radiation.

Adjuvant Chemotherapy

Adjuvant chemotherapy is given in addition to other treatments, with the goal of curing cancer or lowering the risk of cancer coming back. Adjuvant therapy is given after surgery or radiation. If given after surgery, it may be called postoperative chemotherapy. Patients usually receive adjuvant chemotherapy when they have a type of cancer that is likely to reoccur, such as breast or colon cancer. Adjuvant therapy may or may not rid the body of all cancer cells but it should at least lower the risk of cancer coming back, or prolong the patient’s life.

Neo-adjuvant Chemotherapy

Neo-adjuvant chemotherapy (sometimes called preoperative chemotherapy), is also given in addition to other treatments, but it is usually given before surgery in order to shrink the tumor and make it easier to remove or treat with radiation. Sometimes “inoperable tumors” can be surgically removed after neo-adjuvant chemotherapy.

For breast cancer patients, neo-adjuvant chemotherapy can sometimes reduce the tumor enough that a woman can choose to have breast-conserving surgery (lumpectomy) instead of having her whole breast removed (mastectomy).[3] Most often neo-adjuvant chemotherapy will be used on breast cancer patients with tumors greater than 2 cm in size and where the cancer has not spread to other parts of the body.

It is important to remember that the goal of neo-adjuvant chemotherapy is not to cure the cancer but to give the patients more options for treatment, including treatments that are more effective and less radical.

Palliative Chemotherapy

Non-curative chemotherapy for prolonging life and reducing symptoms is called palliative chemotherapy. Palliative chemotherapy is often given to patients with advanced cancer in hopes of making patients more comfortable toward the end of life.  It is sometimes given in combination with other cancer treatments.

The type of palliative chemotherapy a patient receives depends on the patient’s type of cancer and prognosis. Palliative chemotherapy is usually for patients with non-small-cell lung cancer, pancreatic cancer, or colon cancer.

Maintenance Chemotherapy

Maintenance chemotherapy is given to help keep the cancer from coming back in patients whose cancer went away after the initial treatment. In other words, the goal of maintenance therapy is to prevent reoccurrence after the cancer has gone into remission.  This kind of chemotherapy, which may include drugs, vaccines or anything shown to kill cancer cells—may be taken for a longer time than other forms of chemotherapy.[4]

Maintenance therapy is most commonly used by patients who are diagnosed with late stage non-small cell lung cancer. Their cancer usually cannot be completely wiped out but it can be reduced and then kept in check for months or even years. Like palliative therapy, maintenance therapy is aimed at prolonging life and keeping the patient from getting worse, not curing the patient.

Maintenance therapy is also called consolidation therapy, post-remission therapy, intensification therapy, or early second-line therapy.[5] Because chemotherapy has terrible side effects and since maintenance therapy is given over long periods of time, it should only be used if it does more good than harm. The maintenance therapy should help the patient feel better or live longer without prolonging suffering.

Patient Concerns About Chemotherapy

Patient Misunderstandings About Chemotherapy

A study in the journal Cancer by Dr. Inga Lennes and her colleagues at Massachusetts General Hospital surveyed 125 newly diagnosed cancer patients who were receiving their first round of chemotherapy. The researchers wanted to see if the patients’ perception of chemotherapy and why they were receiving it matched their doctors’ reasons for giving it. Patients were asked, in writing, to choose from four possible responses describing the goal of their treatment as explained to them by their oncologist:

1) to decrease the chance the disease will return, also called adjuvant treatment;

2) to provide a prolonged time without any evidence of disease, also called cure;

3) to control the growth of the cancer without getting rid of it completely to prolong life; and

4) to reduce side effects and symptoms of the cancer to promote your comfort, also called palliation.

Patients were allowed to choose more than one answer. Patients who selected one or both of the first two responses were categorized as viewing their chemotherapy as curative. Those that selected the third or fourth response viewed their chemotherapy as non-curative.

Three out of four patients correctly identified their oncologist’s reason for prescribing chemotherapy. Nearly all of these patients (99%), however, were the ones being given chemotherapy to cure their cancer and keep it from coming back. Among the 25% of patients who did not correctly identify their oncologist’s reason for prescribing chemotherapy, two-thirds (66%) thought the chemotherapy would cure their cancer when, in fact, that was not the oncologist’s goal. Patients who were undergoing non-curative chemotherapy—to prolong life with cancer and reduce symptoms from cancer – had a harder time understanding what their oncologist hoped to achieve than did patients whose chemotherapy was curative.

Why are Patients Confused About Chemotherapy?

There are many possible reasons why patients misunderstand the goal of their chemotherapy.  Studies show that doctors are not good at communicating bad news and want to appear hopeful.  They may provide written information that some patients can’t understand.

Physician and Patient Optimism

When the prognosis is bad (the patient is not going to survive the cancer), physicians may be deliberately unclear or vague, or they may be overly optimistic about the patient’s chances. As a result, patients have a difficult time accepting that their disease is incurable.

Studies have found that cancer patients want their doctors to “maintain an attitude of hope”, but doing so may mislead or confuse patients with advanced cancer. A small study of 28 patients in three hospitals in England taped the first consultation after the patient had received his or her diagnosis, usually after surgery to remove the cancer had been performed.[6] They found that when doctors are discussing bad or uncertain news about a patient’s prognosis or treatment, they pair it with some positive information.  For example, in one conversation between a patient with laryngeal cancer and his doctor, the doctor gave the bad news that his cancer probably would not be cured, quickly followed by hopeful news and the statement that there is a “very good chance” that radiation “will work.”  This good news-bad news approach can confuse patients and result in unrealistic expectations of treatment.

A study in Australia, using recorded conversations between 118 patients and 9 oncologists, found that 3 out of 4 patients had been told that their cancer was incurable, and 85% had been informed of the aim of treatment.[7] After giving the information, only 10% of physicians checked to see if the patient actually understood it. One way to check if the patient has understood is to have her explain to the doctor what she just heard in her own words.

A different study found that patients who incorrectly believed that their chemotherapy would cure their cancer were the ones who gave their doctors the highest communication scores.[8] Clearly, doctors who put a positive spin on a patient’s condition may be the most popular, but their mixed messages are confusing to patients.

Patients with incurable cancer need optimism to help them cope  with the news that they are going to die.[9] While maintaining hope in the face of death is important, patients with too sunny an outlook can have  unrealistic expectations of treatment.

Health Literacy and Informed Decision Making About Cancer Treatments

Health literacy is the ability of patients to understand health information presented to them that they need to make appropriate health decisions. All patients face the challenge of making treatment decisions based on the information their physicians have provided them. This is especially true for cancer patients, who are faced with new medical terminology, unclear statistics, and often-vague prognoses. Experts agree that the lack of health literacy among cancer patients may make it difficult for them to understand their treatments and their prognosis.

Patients over the age of 60 have some of the lowest levels of health literacy, with as many as 80% struggling to understand paperwork given to them by their doctors, including consent forms.[10] In the U.S., younger patients and patients who are native English speakers understand the purpose of their chemotherapy better than older patients or non-native English speakers.

Patients with low health literacy are less likely to ask questions when they don’t understand what they’re reading or what they’re doctor has told them. This is a chicken and egg situation: people with low health literacy lack the confidence or educational and cultural training to ask questions of people with authority (doctors). Meanwhile, the failure to ask questions and get doubts resolved contributes to low health literacy.

Over the last decade, there has been a shift in the medical community from the concept of informed consent, in which patients agree to the doctor’s recommended course of treatment, to the idea of informed decision-making, in which patents and doctors exchange information, ask each other questions, and come to a final treatment decision together as a team. This more patient-centered approach can help cancer patients understand the goal of their care.

In addition, research shows that cancer patients who asked their doctors at least three questions had a better understanding of their treatment options and were more confident in making decisions.

The Bottom Line

  • 1 out of 4 patients receiving chemotherapy do not understand the goal of therapy.
  • The lack of patient understanding is due to a number of factors, including poor and overly optimistic communication between doctors and cancer patients, low health literacy among patients, and the many new terms used in explaining chemotherapy.
  • Patients who misunderstand the goal of their chemotherapy may opt for longer or more aggressive treatment than they would if they understood their prognosis better.
  • To improve communication between cancer patients and their doctors, doctors should use the communication technique known as “ask, tell, ask.” Doctors first ask what the patient wants to know, then they provide the information the patient has asked for, and then they ask the patient to explain what they’ve just learned.8
  • Doctors should regularly ask their patients to summarize what they have just heard, including the goal of the chemotherapy.  Patients should ask doctors questions, including asking what terms mean as well as anything they are uncertain or worried about.

References:

    1. Lennes IT, Temel JS, Hoedt H et al. Predictors of Newly Diagnosed Cancer Patients’ Understanding of the Goals of Their Care at Initiation of Chemotherapy. Cancer. 2012; DOI: 10.1002/cncr.27787
    2. National Cancer Institute. Chemotherapy and You: Support for People With Cancer. Accessed November 28, 2012. http://www.cancer.gov/cancertopics/coping/chemotherapy-and-you/page2.
    3. Thompson AM, Moulder-Thompson SL. Neoadjuvant treatment of breast cancer. Annals of Oncology. 2012;23:231-36. Doi:10.1093/annonc/mds324.
    4. National Cancer Institute.  NCI Dictionary of Cancer Terms. Accessed November 9, 2012. http://www.cancer.gov/dictionary?CdrID=45768
    5. Owonikoko TK, Ramalingam SS, Belani CP. Maintenance Therapy for Advanced Non-small Cell Lung Cancer: Current Status, Controversies, and Emerging Consensus. Clinical Cancer Research. 2010;16:2496-2504. Doi:10.1158/1078-0432.CCR-09-2328.
    6. Leydon GM. “Yours is potentially serious but most of these are cured”: optimistic communication in UJ outpatient oncology consultations. Psycho-Oncology. 2008; 17: 1081-88. DOI: 10.1002/pon.1392.
    7. Gattellari M, Vaigt KJ, Butnow, PN et al. When the Treatment Goal Is Not Cure: Are Cancer Patients Equipped to Make Informed Decisions? Journal of Clinical Oncology. 2002; 20; 2:503-13.
    8. Weeks JC, Catalano PJ, Cronin A et al. Patients’ Expectations about Effects of Chemotherapy for Advanced Cancer. NEJM. 2012; 367:1616-1625. DOI: 10.1056/NEJMoa1204410
    9. Smith TJ, Longo DL. Talking with Patients about Dying. NEJM. 2012; 367:1651-1652. DOI: 10.1056/NEJMe1211160.
    10. Amalraj, Sunil, et al. Health literacy, communication, and treatment decision-making in older cancer patients. Oncology 15 Apr. 2009: 369. Academic OneFile. Web. 22 Oct. 2012.

Is Newer and More Expensive Care Better?

Sarah Miller, RN and Laura Covarrubias

Is more medical care really better? What about all these new, expensive drugs and high-tech surgeries? Do they save lives or improve health?

If you answered yes to these questions, you are not alone, but you may not be correct. A study done by the American Institutes for Research on insured adults between ages 18 and 64, found that most thought that more care, newer medical technology, and more expensive care were better. In addition, the adults interviewed believed that all care met minimum quality standards, and they were skeptical of evidence-based medical guidelines.

A typical response was “I don’t see how extra care could be harmful to your health. Care would only benefit you.” Although this belief is widely held, it is not accurate.  For example, if a healthy 80-year old man or woman without cancer symptoms is screened for various types of cancer, any abnormal findings are likely to result in treatment that is unlikely to benefit them.  That is why the U.S. Preventive Services Task Force usually recommends against screening 80-year olds for these cancers, although they recommend diagnostic testing for patients of all ages if they have symptoms.

“You get what you pay for” is another popular opinion, with many people assuming that more expensive care is superior. However, care that is far less expensive is sometimes just as good or even better.  One example of this is robotic prostatectomy, a surgery for men with prostate cancer that is done by a robot operated by the surgeon. Many men want this type of surgery, which costs $2,600 more than a regular prostate surgery. Some studies have shown that men who have the robotic surgery have lower rates of complications after the surgery, but others have shown that there is no difference. Most researchers who have conducted studies on this agree that the robotic surgery has not yet been proven to be any better than regular prostate surgery.

Even if robotic surgery isn’t worse than the regular surgery, is it worth the extra $2600? Consider this: for every two insured men that choose to have regular rather than robotic surgery, the cost savings could more than pay for one uninsured man with prostate cancer to have this life-saving surgery.[5] This is important to consider in the United States, where many people are not able to afford their medical care.

A similar idea that many patients have is “if it’s newer, it’s better.” While it may seem like new treatments would be chosen because they are better, this is rarely true. For example, cetuximab (also called Erbitux) was introduced in 2008 as a new addition to treatment for lung cancer patients. Although the drug was called a breakthrough in treatment for lung cancer, the average patient taking the drug lived only 1.2 months longer than patients not taking the drug. And in the many months of taking the drug, 85% of patients experienced skin toxicity, which often caused great discomfort (Fojo & Grady).  And despite the small possible advantages of the drug, it cost $80,000 for just a few months of treatment, resulting in huge medical bills that many families could not afford.  Avastin for Stage 4 breast cancer is an even more dramatic example.  Avastin is used for many cancers, but after several years, it became clear that on average, the breast cancer patients taking it were not living any longer and were more likely to have a stroke or other very serious and debilitating reaction to the drug that could make their last months much more painful physically and psychologically.

Cereal companies regularly add “New” in big letters on cereal boxes, because that sells more products (even if what is new might be a new toy inside).  Patients should be more cautious.  While some patients may want to take the chance that a new drug might be better, but many would rather know what the risks are before trying a new medication that could be worse than the tried and true treatments.

Evidence-Based Guidelines

Medical guidelines are usually established by a group that is considered expert in the subject of the guidelines. Medical guidelines are usually based on evidence from scientific research and are written according to the agreement a group of experts comes to about what the research tells them is the best for patients.

Unfortunately, research indicates that many adults are skeptical about guidelines.  Many seemed to think that asking providers to use guidelines did not allow them to make decisions based on their own expertise and that they could be used to ration care so that people did not “take” too much. One participant said that medical guidelines are “taking your choice away and putting it in someone else’s hands.”

Contrary to the mistaken belief that providers were restricted to actions dictated by the guidelines, in reality, guidelines are meant to guide providers by making suggestions based on the best evidence. Providers are still able to make the final recommendation to patients based on their professional expertise.

Is a doctor’s individual experience more valuable than guidelines?  That’s hard to say, but usually it would not be.  Guidelines are based on evidence from medical research comparing large groups of people who have had different types of treatment. Therefore, guidelines based on science will, on average, provide the best care for most people.  However, a physician with impressive expertise may be able to predict which patients are more likely to benefit from other types of treatment.

For example, for years, it was recommended that women between 40 and 69 years of age have a mammogram every year to screen for breast cancer. In 2007, however, the American College of Physicians changed their guidelines to leave it up to physicians to decide whether women between 40-50 needed annual mammograms.  In 2009, the US. Preventive Services Task Force wrote new guidelines, based on research evidence from thousands of women. The new guidelines recommended that women age 40-49 should not have regular mammograms to screen for breast cancer unless they had an especially high risk of breast cancer, and that women age 50-75 should have screening mammograms every two years – extending the age to older women but cutting the frequency from annually to every other year.

Many people challenged the new guidelines believing they could substantially delay the detection of cancer, especially for women under 50.  Isn’t it always better to have a chance to detect cancer earlier?

The answer is yes and no. Although mammograms save the lives of many women (including those in their 40’s), they also expose women to harmful radiation that can actually cause cancer over the course of women’s lifetimes. The researchers considered other forms of harm as well, such as the emotional trauma of a “false positive” results that result in stressful and expensive biopsies.  They concluded that the potential for harm outweighed the potential benefits of mammograms for the average women under age 50 and over 75, as did annual rather than biyearly mammograms for women age 50-75.

Many people did not agree with the U.S. Preventive Services Task Force’s interpretation of the evidence, however.  It is partly a matter of interpretation.  The U.S. Preventive Services Task Force was advising average women, and some cancer advocates believe that it is too difficult to predict whether a person is at high risk or not.  As a result, groups such as the American Cancer Society prefer to err on the side of over-treatment and radiation exposures, rather than on the side of potential under-treatment and reducing radiation exposure.

Health care providers are able to judge the two sets of guidelines and decide what to recommend for specific patients. For example, a woman in her 30’s who has many family members with breast cancer, including some at a young age, may be advised to have digital mammograms every other year in their 30’s (because they are more accurate than traditional mammograms and use less radiation) and annually after that.

“All care meets minimum quality standards” is another common belief.  Most could imagine providers making an occasional mistake, but few thought that there were any providers who consistently delivered a quality of care that did not meet basic standards.[1] Unfortunately, research shows that health care varies from doctor to doctor, and many do not meet minimum quality standards. The quality of care that doctors provide varies by the type of clinic where they work (publicly or privately funded, for instance), the communication skills of the doctor, and even how much sleep the doctor has been getting (Manusukhani; Kenny; Philipson).

What Can We Learn From This?

This study gives some insight into why we spend so much on health care and why efforts to improve medical care are often opposed as “rationing” or “death panels.” Unfortunately, most patients want the newest and most expensive care, and don’t understand that it may not be as safe or as effective as older, less expensive treatments.

In the United States, we spend more per person on health care than any other country, and yet our citizens are not as healthy as those in Japan, France, and Cuba, countries that spend far less per person on health care.

In addition to wasting money on treatments that are no better, and are sometimes inferior, our wasteful spending also means that we have less money for other essential services, such as education, housing, and national security.4

Of course, there is a lot of very expensive medical care that is medically necessary and could save a person’s life, such as trauma care in an emergency room for someone who has been in a serious car accident. But, there are also popular treatments that are expensive and not necessary, like a woman having labor induced for convenience when it would be safer and less expensive to have a natural birth. The key is to eliminate the unnecessary care so that we can continue to afford the necessary, beneficial care.

When it is not clear whether more expensive care actually helps or is just a waste of money, medical research can point us in the right direction. That’s why it is a good strategy to require “comparative effectiveness research” to determine whether, for example, robotic prostate surgery is better than regular surgery, or just needlessly more expensive.  It is often not obvious which treatments are the best, and sometimes they are the most expensive treatments but other times they may be the least expensive treatments or no treatment at all.

Doctors and patients can be part of improving medical care, by asking whether research conclusively shows which treatment is safer and which is most effective, instead of wrongly assuming that guidelines are aimed at saving money, not improving care.

References:

  1. Carman, KL; Maurer, M; Mathews, J; Dardess, P; McGee, J; Evers, M; & Marlo, KO, Evidence that consumers are skeptical about evidence-based health care, Health Affairs, 7 1400-6, 2010.
  2. Centers for disease control and prevention. Births: Final data for 2006, National Vital Statistics Reports.
  3. Caughney, AB; Sundaram, V; Kaimal, AJ; Cheng, YW; Geinger, A; Little, SE; Lee, JF; et.al. Maternal and Neonatal Outcomes of induction of labor. Evid Rep Technol Assess. 176 pp.1-257, 2009.
  4. Bodner-Adler, B; Bodner, K; Patiesky, N; Klimberger, O; Chalubinski, K; Mayerhofer, K; & Husslein, P; Influence of labor induction on obstetric outcomes in patients with prolonged pregnancy: A comparison between elective labor induction and spontaneous onset of labor beyond term. The Middle European Journal of Medicine. 117(7-8) pp. 287-92, 2005.
  5. Bolenz, C; Gupta, A; Hotze, T; Ho, R; Cadeddu, JA; Roehrborn, C; & Lotan, Y; Cost Comparison of Laproscopic, Robotic, and Open Radical Prostatectomy for Prostate Cancer, European Urology, 57 pp. 453-8, 2010.
  6. Lowrance, WT; Elkin, EB; Jacks, LM; Yee, DS; Jang, TL; Laudone, VP; Guillanneau, BD, Scardino, PT; & Eastham, JA, Comparative effectiveness of prostate cancer treatments: A population-based analysis of postoperative outcomes, The Journal of Urology, 183, 1366-72, 2010.
  7. Weizer, AZ; Strope, S; and Wood, DP, Margin control in laproscopic robotic prostatectomy: What are the REAL outcomes? Urologic Oncology: Seminars and Original Investigations, 28 pp.201-14, 2010.
  8. Barocas, DA; Salem, S; Kordan , Y; Herrell, SD; Chang, SS; Clark, PE; Davis, R; Baumgartner, R; Phillips, S; Cookson, MS; & Smith, JA, Robotic assisted laproscopic prostatectomy for clinically localized prostate cancer: Comparison of short-term biochemical recurrence-free survival, The Journal of Urology, 183, 990-6, 2010.
  9. Murphy, DC; Bjartell, A; Ficarra, V; Graefen, M; Haese, A; Montironi, R; Montorsi, F; Moul, JW; Novara, G; Sauter, G; Sulser, T; & van der Poel, H, Downsides of robot-assisted laproscopic prostatectomy: Limitations and complications. 57 pp. 735-46, 2009.
  10. Coelho, RF; Chauhan, S; Palmer, KJ; Rocco, B; Patel, MB; & Patel, VR, Robotic-assisted radical prostatectomy: A review of outcomes, British Journal of Urology International, 104, 1428-35, 2009.
  11. US Preventive Services Task Force, Screening for breast cancer: Recommendation statement 2009. Retrieved from: http://www.ahrq.gov/clinic/uspstf09/breastcancer/brcanrs.htm  on July 20, 2010.
  12. American Cancer Society, American Cancer Society Guidelines for the Early Detection of Cancer: Breast Cancer, 2010, Retrieved From: http://www.cancer.org/Healthy/FindCancerEarly/CancerScreeningGuidelines/american-cancer-society-guidelines-for-the-early-detection-of-cancer  on July 20, 2010.
  13. Smith, S; Newhouse, JP; & Freeland, MS; Income, insurance and technology: Why does health spending outpace economic growth? Health Affairs, 28(5) pp. 1276-84, 2009.
  14. Aaron, HJ and Ginsburg, PB; Is health spending excessive? If so, what can we do about it? Health Affairs

Lowering the Cost of Cancer Treatment

Krista Brooks, Cancer Prevention and Treatment Fund

The number of new cases of the four most common types of cancers (prostate, breast, lung, and colorectal) have been declining since 1998, but Americans are still spending billions in cancer care costs.[1] In 2006, cancer care accounted for an estimated $104.1 billion in medical care spending in the United States and that number will continue to increase in the upcoming years.[1] The National Cancer Institute found that if incidence (which means the number of new cases), survival, and treatment costs stay the same, cancer costs in 2020 will show a 27% increase from 2010 solely based on the growing and aging population in the U.S.[2] As cancer treatment becomes more effective, the increasing number of cancer survivors will require additional care, which will also contribute to overall cost increases.[2] While these trends reflect a changing U.S. population and the increase in cancer survivors, they do not explain why each individual must pay so much for cancer care and treatment.

A survey conducted by the Kaiser Family Foundation found that one in four families affected by cancer say the experience used up all or most of the patient’s  savings, and one in eight say they borrowed money from relatives.[3] For the uninsured, the burden was even higher: “one in four delayed or decided not to get treatment because of its cost.”[3] These treatments are often essential, but the high costs are often not sustainable for individuals, families, or for the U.S. healthcare system.

Why do Cancer Treatment Costs Continue to Rise at Astronomical Rates?

Pharmaceutical companies, physician practices, and cancer screenings all play a role in the rising costs of treating cancer patients.  The treatment costs could be reduced, however.  Fortunately, there are now a variety of treatment options from which most patients can choose.  One problem is that pharmaceutical companies tend to charge higher prices for their new drugs; for example, Provenge, used to fight prostate cancer, is $93,000 for just one course of treatment.[4] Avastin typically costs stage 4 breast cancer patients more than $80,000, but the latest research indicates that for most patients it does not increase survival and is likely to harm quality of life.[5,6] Some cancer medications range from $5,000 to $10,000 per month, which over several years really adds up.[7] Many of these new drugs work for relatively few people, while most patients pay thousands of dollars and do not benefit or may even be harmed.  The companies have no incentive to determine which patients are most likely to benefit, if they can instead sell the drugs to most patients, including those who won’t benefit.  That leaves doctors and patients trying many expensive treatments until they find one that works for each individual.  Insurance companies, Medicare, and sometimes the individual must pay these exorbitant costs during this trial and error treatment.

Another factor that contributes to the high cost of cancer treatments can be a physician’s own treatment recommendations.  Physicians are there to help their patients, but research has shown that physicians who have financial ties to specific companies tend to recommend medical products made by those companies.[8,9] Many patients also rely on Medicare, which is not allowed to deny or limit cancer treatment based on cost.  As a result, Medicare patients and their doctors often have no incentive to choose equally effective but less expensive medications and treatments.[10,11] Doctors and patients also have little incentive to question high-priced treatments.[12] Unfortunately, physicians frequently do not adhere to evidence-based guidelines, leading them to sometimes prescribe and perform tests that may be more expensive than beneficial to patients.[13]

Cancer costs can add up-even before cancer is actually diagnosed.  Cancer screenings are designed to increase the number of patients who are diagnosed early, before they have any symptoms. When performed according to recommended guidelines, screening can help patients get a much earlier start on treatment. However, cancer screening tests often identify abnormalities that may or may not be cancer, which can result in expensive testing, unnecessary treatment, and added costs.  These costs can’t always be avoided, but they are increased when screening guidelines are not followed.  For example, a recent study found that a large number of elderly men were being screened for prostate cancer even though they were beyond the target age range for testing.[14] Prostate cancer screening tests can cause serious harm, exposing men to unnecessary treatments as well as unnecessary costs.  Similar results have been found for cervical cancer screening in women.  Certain types of HPV (Human Papillomavirus) have been linked to cervical cancer, so physicians like to determine the type of HPV as a method to screen for cervical cancer.  Unfortunately, a Center for Disease Control (CDC) study found that physicians are performing unnecessary and expensive routine HPV tests.[15] When HPV tests were initially developed, two types of tests were run together: one to detect HPVs that can cause cancer, and one for HPVs that don’t cause cancer.  However, now that an HPV test that focuses only on cancer-causing HPV has been available, that is the only HPV test recommended for physicians to use.  This recommended test should only be done for women over 21 who have inconclusive pap smear results, or women over 30 who are undergoing pap smears. The problem is that many physicians and clinics are using the cervical cancer HPV test routinely for all patients, or are using both the recommended HPV test and the non-recommended test for non-cancerous HPV; either of these inappropriate uses results in a doubling of medical bills, without any additional benefit to the patient.[16] Screening mammograms for women above or below the recommended age range, or given more frequently than recommended, also result in unnecessary anxiety, treatment, and medical expenses, which outweigh the benefits for most women.[17]

Is There Any Way to Reduce These Costs?

The skyrocketing cost of cancer treatments has brought the issue to public attention, as politicians, doctors, and organizations speak out about ways that we can work together to reduce these costs   Dr. Howard Brody’s “Call to Action” in the New England Journal of Medicine challenged physicians to name five high-priced treatments that are commonly used in practice, but have not been shown to be highly effective in patients.  He pointed out that if physicians can exchange these practices for low-cost, more effective treatments, a small dent could be made in rising healthcare costs.[18] Two oncologists responded to Brody’s request with five ways to reduce costs for cancer treatments.  They include using imaging and tests only where benefits to patients have been shown, limiting chemotherapy for people that are very weak and would not benefit from this additional treatment, and a greater coordination of care.  Additionally, they suggest an increased focus on palliative care, which has been found to make patients more comfortable, have better health outcomes, and reduce the number of costly and often ineffective treatments tried during the patient’s final months.[19,20]

To combat the rising costs of medications and medical devices, the 2010 health care reform law encourages more comparative effectiveness research through the formation of a non-profit Patient Centered Outcomes Research Institute.[21] This institute will help ensure that new medical treatments are studied to determine if they are better or worse than ones already on the market.  Similarly, two researchers are proposing a new type of regulation called “reference pricing” to ensure that patients are getting more out of these new treatments.  Reference pricing would require that medical products paid for by Medicare be tested to compare them to similar products that are already on the market. The companies would have 3 years to prove that their new product is better than the ones already on the market. If tests do not show that the product is safer or more effective, it could not be sold at a higher price than the older products on the market.  While reference pricing is not required as part of the health care reform law, it could be used as a strategy under the law to encourage medical product manufacturers to finance comparative effectiveness research.[22]

Changing physician and pharmaceutical company practices might seem like a daunting task, but there are some small steps that you as an individual can do to help lower costs associated with cancer treatments.  It is important that you discuss your financial and medical situation with your doctor. Make sure that you fully understand your illness and make sure your doctor fully understands your financial situation.  In some cases, your doctor may be able to prescribe less expensive, but just as effective, drug treatments that could save you money.[23] Additionally, it is important to talk to your doctor about regular cancer screenings and your family’s history of certain cancers or diseases.  You might be in the target age-range or at risk for other reasons that meet the standards of some screenings, but not for others.  This will help to maximize the benefits you will receive from these health screenings and help to eliminate unnecessary costs or treatments.[24]

Patients deserve a high standard of quality of care. Fortunately, it is possible to lower costs while maintaining or even improving the quality of care. We can do this with unbiased research to determine which treatments are most effective and by creating regulatory methods to ensure that the cost of medications must reflect their effectiveness.

If you or a loved one has been diagnosed with cancer and would like to learn about financial assistance options, please visit The National Cancer Institute (NCI) web site https://www.cancer.gov/about-cancer/managing-care/track-care-costs.  They offer a wide variety of resources to help with cancer treatment costs for those with and without health insurance.

References:

  1. National Cancer Institute, NIH, DHHS (2010) Cancer Trends Progress Report – 2009/2010 Update, Bethesda, MD, http://progressreport.cancer.gov.
  2. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, and Brown ML. (2011). Projections of the Cost of Cancer Care in the United States: 2010-2020., Journal of the National Cancer Institute 103(2). Retrieved from http://jnci.oxfordjournals.org/content/103/2/NP.2.full
  3. USA Today/Kaiser Family Foundation/Harvard School of Public Health National Survey of Households Affected by Cancer. November 20, 2009.http://www.kff.org/kaiserpolls/pomr112006pkg.cfm. Accessed February 10, 2010
  4.  No Author, (2011) The costly war on cancer. The Economist. Retrieved from http://www.economist.com/node/18743951
  5. Twombly, R. (2011). Avastin’s uncertain future in breast cancer treatment . Journal of the National Cancer Institute, 103(6), Retrieved from http://jnci.oxfordjournals.org/content/103/6/458.full
  6. Ranpura, V, Hapani, S, and Wu, S. (2011). Treatment-related mortality with bevacizumab in cancer patients. The Journal of the American Medical Association, 305(5), Retrieved from http://jama.ama-assn.org/content/305/5/487.full
  7. Goozner, M. (2011) Health care reform: Prove it works and CMS will pay. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2010/10/05/Health-Care-Reform-CMS-Wants-Proof-to-Pay.aspx
  8. Elkin EB and Bach PB (2010). Cancer’s next frontier: Addressing high and increasing costs. The Journal of the American Medical Association, 303(24). Retrieved from http://jama.ama-assn.org/content/303/11/1086.short?home
  9. Jost, TS. (2010). Oversight of marketing relationships between physicians and the drug and device industry: a comparative study. American Journal of Law and Medicine, 36. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/20726399
  10. Weight, CJ, Klien, EA, and Jones, JS. (2008). Androgen deprivation falls as orchiectomy rates rise after changes in reimbursement in the U.S. Medicare population. Cancer, 112(10), Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/18393326
  11. Goozner, M. (2011) Health care reform: Prove it works and CMS will pay. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2010/10/05/Health-Care-Reform-CMS-Wants-Proof-to-Pay.aspx
  12. No Author, (2011) The costly war on cancer. The Economist. Retrieved from http://www.economist.com/node/18743951
  13. Brody, H. (2009). Medicine’s ethical responsibility for health care reform – the top five list. New England Journal of Medicine. Retrieved from http://healthpolicyandreform.nejm.org/?p=2616
  14. American Society of Clinical Oncology (2011). Many elderly men are undergoing unnecessary PSA screenings, researchers find. ScienceDaily. Retrieved June 20, 2011, from http://www.sciencedaily.com­/releases/2011/03/110328161848.htm
  15. Lee, JW, Berkowitz, Z, and Saraiya, M. (2011). Low-risk human papillomavirus testing and other nonrecommended human papillomavirus testing practices among U.S. health care providers. Obstetrics & Gynecology, 118(1), doi: 10.1097/AOG.0b013e3182210034
  16. Lee, JW, Berkowitz, Z, and Saraiya, M. (2011). Low-risk human papillomavirus testing and other nonrecommended human papillomavirus testing practices among U.S. health care providers. Obstetrics & Gynecology, 118(1), doi: 10.1097/AOG.0b013e3182210034
  17. Quanstrum, KH and Hayward, RA. (2010). Lessons from the mammography wars. New England Journal of Medicine, 363. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMsb1002538
  18. Brody, H. (2009). Medicine’s ethical responsibility for health care reform – the top five list. New England Journal of Medicine. Retrieved from http://healthpolicyandreform.nejm.org/?p=2616
  19. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, and Brown ML. (2011). Projections of the Cost of Cancer Care in the United States: 2010-2020., Journal of the National Cancer Institute 103(2). Retrieved from http://jnci.oxfordjournals.org/content/103/2/NP.2.full
  20. Smith TJ and Hillner BE. (2011). Bending the cost curve in cancer care. New England Journal of Medicine. Retrieved from http://healthpolicyandreform.nejm.org/?p=14541&query=home
  21. Kaiser Family Foundation. (2011, April 19). Summary of new health reform law. Retrieved from http://www.kff.org/healthreform/8061.cfm
  22. Goozner, M. (2011) Health care reform: Prove it works and CMS will pay. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2010/10/05/Health-Care-Reform-CMS-Wants-Proof-to-Pay.aspx
  23. Consumers Union of U.S. (2009, March). 10 ways to reduce your drug costs. Retrieved from http://www.consumerreports.org/health/prescription-drugs/10-ways-to-reduce-your-drug-costs/overview/10-ways-to-reduce-your-drug-costs.htm
  24. Quanstrum, KH, and Hayward, RA. (2010). Lessons from the mammography wars. New England Journal of Medicine, 363. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMsb1002538

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Cancer Researchers with Industry Ties Report “Rosier” Results

Stephanie Portes-Antoine and Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund

With all of the cancer studies being performed today, how can consumers be sure of their accuracy? A study by Dr. Reshma Jagsi at the University of Michigan and her colleagues indicates that cancer studies are more likely to have positive results when the researchers have ties to the company that makes the product being studied.[1]

This study focused on cancer research articles published in eight medical journals, including Cancer, the Journal of the National Cancer Institute, the New England Journal of Medicine, the Journal of the American Medical Association, and the Lancet. An author was categorized as having a conflict of interest if he or she reported one or was employed, at the time of publication, by the company that makes the medical product being studied, or if a drug or medical device manufacturer was a source of funding for the study. Dr. Jagsi and colleagues relied exclusively on disclosures and information given in the articles themselves. They did no further investigation into authors’ financial ties to industry such as checking board memberships or employee listings. For this reason, the authors believe that their findings may underestimate the extent and effects of conflicts of interest in cancer research.

The authors reviewed 1,534 articles on cancer studies published in 2006. Twelve percent of the articles included at least one author employed by industry—a company that makes medical products—and 17% of articles declared industry funding. The articles most likely to have conflicts of interest included those with authors from medical oncology departments; articles from North America; and articles where the first or last author was a man (these are most likely to be the senior author or principle investigator).  Studies having to do with diagnostic radiology were least likely to have conflicts, whereas those involving prostate, lung, skin, and hematologic (blood-related) cancer were most likely to have conflicts.

Nearly one-quarter of the articles disclosed a conflict of interest. By looking at funding sources and author affiliations, Dr. Jagsi and colleagues concluded that 29% of articles had an apparent conflict of interest, meaning that disclosures do not tell the whole story. This discrepancy can be due to many factors: some journals may have chosen to omit certain information in the disclosures; different journals have different guidelines and policies on disclosure; and cultural norms regarding disclosure vary from one region of the world to another.

 

Cancer studies with conflict
Industry funding of study
17%
Industry employee
12%
Consulting
12%
Industry funding of other research by author
11%
Honoraria
9%
Stock
8%
Lecture fees
3%
Corporate board
3%
Industry-supplied drugs or technology
2%
Testimony/legal team
1%
Patent
1%

Source: “Frequency, Nature, Effects, and Correlates of Conflicts of Interest in Published Clinical Cancer Research,” Cancer. 2009; 115:2783-2791. Table in this form reproduced from: http://www.ama-assn.org/amednews/2009/05/25/prsa0525.htm

Industry-funded studies were far more likely to focus on treatment than non-industry funded studies (62% vs. 36%) and much less likely to look at epidemiology, risk factors, and effective means of disease prevention and diagnosis (20% vs. 47%).

Randomized clinical trials were more likely to find that a treatment or intervention improved patient survival if a conflict of interest was present. Dr. Jagsi and his co-authors suggest that several factors may account for this. Industry-funded research may tend to design studies that are likely to show their products are effective. The example they give is trials where a drug is tested against a placebo rather than against a drug already in use. Also, journals may be more interested in publishing positive results, which would inadvertently favor studies whose authors have conflicts of interest.

Since randomized clinical trials are the gold standard for the adoption of new therapies and technologies, these conflicts of interest or “funder effects” have serious implications for cancer treatment and public health. Even if industry funding does not lead researchers to exaggerate a treatment or product’s benefits, studies have indicated that they may tend to not publish negative findings. For example, an analysis of 44 studies on the cost-effectiveness of new oncology drugs found that those sponsored by industry were less likely to conclude that a drug was not cost-effective than studies funded by agencies or institutions without a profit incentive, such as government or university-funded studies.[2] In fact, the industry-funded studies were eight times less likely to assess a drug unfavorably than non-industry studies.

Studies dating back as far as 1986 have shown that clinical trials funded by industry are far more likely to favor new therapies over traditional ones.[3] New therapies usually cost more, and usually less is known about their potential risks.

Medical researchers often rely on industry funding, and this is true for cancer researchers. In a study published in 2013, Dr. Francisco Emilio Vera-Badillo and colleagues at the University of Toronto found that 63% of the breast cancer studies they looked at were funded by industry, but they did not find that the results of the studies necessarily favored the companies that paid for them.[4] Other studies, however, indicate that industry funding affects not only the way results are reported but the type of research that is carried out. This is why it is important that medical research—which is for the benefit of all, not just those who manufacture drugs and other therapies—receive funding from diverse sources, including those without a profit incentive. Since the new research indicates that not all conflicts of interest are acknowledged in medical publications, journals should implement stricter policies regarding accurate disclosure of potential conflicts of interest. In addition, peer reviewers and editors should scrutinize the study design and data analyses carefully and ask tough questions of authors to ensure the accuracy of the findings and conclusions. These efforts are especially crucial when the studies involve treatment for potentially fatal diseases such as cancer.

For information on the misrepresentation of effectiveness and side effects of cancer treatments, click here.

References:

  1. Jagsi R, Sheets N, Jankovic A, Motomura AR, Amarnath S, Ubel PA. Frequency, nature, effects, and correlates of conflict of interest in published clinical cancer research. Cancer. 2009;115: 2783-2791.
  2. Friedberg M, Saffran B, Stinson TJ, Nelson W, Bennett CL.. Evaluation of conflict of interest in economic analyses of new drugs used in oncology. Journal of the American Medical Association. 1999; 282: 1453-1457
  3. Davidson RA. Source of funding and outcome of clinical trials. Journal of General Internal Medicine. 1986; 1:155-158.
  4. Vera-Badillo, FE, Shapiro, R, Ocana, A, Amir, E, Tannock, IF. Bias in reporting of endpoints of efficacy and toxicity in randomized, clinical trials for women with breast cancer. Annals of Oncology. 2013; 00: 1-6.