Category Archives: Treatment & Management

How to Report Problems With Medical Products to the FDA

National Center for Health Research.


Every year, tens of thousands of consumers suspect that their medicines or medical devices might be causing unexpected side effects. Side effects – also called adverse reactions – can be quite minor, such as a rash or stomach upset, or very serious, such as mental confusion, heart damage or an autoimmune reaction. It is sometimes difficult to tell if the health problem is caused by the medical product or is merely a coincidence. That is why serious problems that are possibly related to a medical product should be reported to your physician and to the Food and Drug Administration (FDA). You do not have to be certain that the health problem is caused by the medical product – the purpose of a tracking program is to figure out if there is a problem by looking for a pattern in the reports. By tracking these reports, the FDA can determine if there is a pattern that may indicate the need to warn consumers or even to withdraw a product from the market.

The FDA has a program called MedWatch for reporting serious reactions and problems with medical products, including drugs and implanted devices.

The process is relatively simple and is outlined on the MedWatch website. You may ask your doctor to fill out a MedWatch form detailing the problem you have been experiencing. The MedWatch form is available online or you or your doctor can request a copy of the form by calling the FDA toll free at 1-888-INFO-FDA (1-888-463-6332).

If for some reason you do not wish to have the form filled out by your doctor or your doctor refuses to fill out the form (doctors are not required by law to complete a report to the FDA), then you can complete the form yourself. MedWatch provides a set of instructions for completing the form on their website, as well as an online form that you can submit on the website.

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you have questions or comments about a specific drug or medical device, you can call the FDA toll free information number at 1-888-INFO-FDA (1-888-463-6332), press 2, followed by 1 for information, then:

  • for dietary supplements, press 2
  • for drug products, press 3
  • for medical devices, press 4
  • for biologics, including human cells, tissues and cellular and tissue-based products, press 6

Reporting problems helps fix them and ensure that other patients do not experience the same unexpected side effects or reactions.

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

Hormonal Therapy for Ductal Carcinoma In Situ (DCIS)

Diana Zuckerman, PhD and Danielle Shapiro, MD, MPH, 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, at which point it is called invasive. 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, but 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]

Some women also try hormone therapy such as tamoxifen or aromatase inhibitors. That is the focus of this article.

DCIS does not need to be treated immediately. A woman can spend a few weeks after her diagnosis to talk with her doctors, learn the facts about her treatment choices, and think about what is important to her before she chooses which kind of treatment to have.

Hormonal Therapy

Hormonal therapy is recommended for some women with DCIS to help prevent breast cancer from developing and to prevent DCIS from returning after it has been surgically removed.  It is only effective for women whose DCIS is “estrogen receptor positive”, which DCIS usually is.

Hormonal therapy is taken as a pill every day for at least 5 years. Side effects include increased risk of endometrial cancer, severe circulatory problems, or stroke. In addition, hot flashes, vaginal dryness, abnormal vaginal bleeding, and a possibility of premature menopause are common for women who were not yet menopausal when they started treatment.[1]

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 (8.2% in women taking tamoxifen vs. 13.4% in 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 (from 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]

What is the benefit of hormone therapy for lumpectomy patients who do not undergo radiation therapy?

Although radiation therapy is usually recommended for lumpectomy patients, it is inconvenient and many women prefer to avoid it.  In addition, radiation is only beneficial for preventing cancer in the one breast, while hormone therapy helps prevent cancer in both breasts. A study of more than 1,700 women with DCIS who underwent a lumpectomy evaluated radiation and/or tamoxifen.  The women were randomly assigned either to radiation, tamoxifen, radiation plus tamoxifen, or no treatment after surgery. 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%. Interestingly, 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]

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]

Side Effects

While there are benefits to using hormonal therapy, tamoxifen and aromatase inhibitors carry risks of serious harms. Because estrogen plays an important role in maintaining strong bones and healthy cholesterol, blocking estrogen can put healthy women at greater risk for heart disease and osteoporosis.

Tamoxifen:

  • endometrial (uterine) cancer- for every 1,000 women, 2 more will develop uterine cancer
  • blood clots- for every 1,000 women, 3 more will develop potentially dangerous blood clots
  • strokes-  for every 100 women, 1 will develop a stroke
  • cataracts
  • hot flashes
  • vaginal discharge
  • vaginal bleeding

source: Medscape

Aromatase Inhibitors:

  • uterine cancer-  for every 1000 women, 20 more will develop uterine cancer
  • blood clots- for every 1,000 women, 20 more will develop a blood clot
  • strokes- for every 100 women, 2 more will develop a stroke
  • Joint pain for every 1000 women, 20 to 100 more will develop joint pains
  • hot flashes
  • vaginal bleeding
  • vaginal discharge

source: Medscape

The Bottom Line

In women diagnosed with DCIS, hormonal therapy can help prevent DCIS from recurring.  If a woman doesn’t undergo radiation therapy, hormonal therapy can reduce her chances of  invasive cancer in the opposite breast, but not invasive cancer in the same breast. And, hormonal therapy used in addition to radiation treatment apparently has no benefit, but does have added risks.

Perhaps most important, women who take hormonal therapies do not live any longer than women who don’t.

Too often, women with DCIS are encouraged to undergo radiation as well as hormonal therapy, but as you can see, the benefits of doing both are not greater than the benefits of choosing one or the other. And, the benefits of either radiation or hormonal therapy are primarily for reducing the chances of recurrence, but there is no benefit in terms of living longer.  Fortunately, almost all women with DCIS will live regardless of which of these treatments they have.

Talk to your doctor about which treatment options may be right for you.

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

Footnotes:

  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
  5. Medscape. Drugs & Diseases. Available online: https://reference.medscape.com/drug/soltamox-tamoxifen-342183#4 and https://reference.medscape.com/drug/arimidex-anastrozole-342208#4

What are the Alternatives to Traditional Radiation Therapy for Breast Cancer?

Dana Casciotti, PhD, Anna E. Mazzucco, PhD, and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

Almost all women with early-stage breast cancer will live just as long if they choose lumpectomy (also called breast conserving surgery) instead of mastectomy. However, traditional radiation treatment is recommended for lumpectomy patients because it lowers their chances of the cancer returning.

Traditional radiation therapy is given on an outpatient basis 5 days each week for 6-8 weeks, and that is a difficult schedule for many patients. Many women living in rural areas or far from the hospital choose to get a mastectomy because daily radiation is so inconvenient.

For some women, radiation to a smaller area of the breast over a shorter period of time may be a useful alternative. These options are called partial breast irradiation (PBI).

PBI can be given with just 5-10 treatments over about a week’s time, and researchers are testing if treatments can be shortened to 2 days. According to experts, PBI can reduce the chances of a tumor coming back in the area around the lumpectomy from 10-25% to 3-4%.[1]

Based on a comprehensive 2016 research review, women who had PBI were more likely to have their tumor come back or to have a new tumor form in the same breast than women who had whole breast radiation treatment (WBRT). However, women who had PBI were not more likely to die any sooner or to later need a mastectomy.[2] 

PBI is not for everyone (see considerations below). Each type of PBI carries a different potential risk than the other types. For example, PBI with brachytherapy carries a higher risk of infection or seroma (fluid filled pocket in the breast tissue after surgery) than PBI with external beam radiation.[3] However, PBI with external beam radiation, increases risk for harmful effects to the lungs and heart. Three-dimensional models can reduce the radiation exposure to normal tissue, but do not completely eliminate risk.[4]

Across many studies, it is not clear whether PBI is more harmful to skin tissue than traditional radiation therapies.[5, 6,7] Harmful effects on the skin are rated on a scale of 1 to 4, with 4 being the worst. The changes in skin appearance include wrinkling, shrinkage, color change, red blotches, thickening, skin loss and destruction, etc.[8]  

PBI has been studied in clinical trials lasting no longer than 5 years, which isn’t really long enough to know if the therapy works the same or better than traditional radiation treatment. Traditional radiation therapy has been proven to be safe and effective for women for at least 15 years after treatment.

Who Should Consider PBI?

The American Society of Therapeutic Radiology and Oncology (ASTRO) provides the following recommendations: [9]

  1. Women aged 50 and over
  2. Early-stage breast cancer that is confined to one defined area of one breast only
  3. Estrogen receptor-positive breast cancer
  4. Women who had a breast lump removed with “clean margins” (no cancer cells were found in the area that was removed surrounding the lump)
  5. Women who did not have chemotherapy prior to surgery

Who should not be given PBI?

  1. Women aged 40 and younger
  2. Women who had the cancer removed but the margins contained cancer cells (“positive margins”)

What are the Types of PBI?

PBI can be given in the following ways:

  1. Intracavitary brachytherapy or MammoSite- A radiation bead is placed in the surgical cavity (the space left in the breast tissue after the breast lump is removed). This can be done at the time of surgery or later.
  2.  Interstitial brachytherapy- Several catheters are placed into the surgical cavity. Radioactive beads can be put in the breast through the catheters.
  3. Intra-operative technique- During the surgery, a machine is used that gives local radiation to the surgical cavity before the wound is closed.
  4. External beam radiotherapy using 3D modeling- Beams of radiation are given from different directions to match the 3D shape of the tumor. This focuses the rays on the tumor while reducing damage to the rest of the breast.

What are the Benefits and Harms of PBI?

Advantages of PBI:

  1. Smaller area of breast is given radiation, which reduces damage to normal breast tissue.
  2. Treatments can be given over days instead of weeks, making it more convenient and easier to schedule with other medical appointments.
  3. Because of the more convenient schedule, more women may be able to choose to get lumpectomy instead of mastectomy.

Disadvantages of PBI:

  1. Increased chances of tumor coming back or new tumor forming in the same breast compared to traditional radiation therapy.
  2. Because PBI can give a bigger dose of radiation, women may have later toxic effects, which affect the way the breast looks.
  3. Invasive approaches (placing beads in the surgical wound or catheters in the wound) can increase the chance of infection and can slow wound healing, which may affect the way the breast looks.

The Bottom Line

Radiation treatment can help women to conserve breast and prevent cancer spread after lumpectomy. PBI can be more convenient in the short run, but in the long run, we do not know if it is as safe or effective as traditional radiation treatment.

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

References:
1. Kuznar, W. ASCO Reading Room: APBI: A Compromise Solution Following BCT–In low-risk breast cancer patients, recurrence rates equivalent to those for WBI. Medpage Today. (July 26, 2016). Available Online: https://www.medpagetoday.com/reading-room/asco/breast-cancer/59322?pop=0&ba=1&xid=tmd-md&hr=trendMD

2. Hickey BE, Lehman M, Francis DP, See AM. Partial breast irradiation for early breast cancer. Cochrane Database of Systematic Reviews 2016, Issue 7. DOI: 10.1002/14651858.CD007077.pub3.

3. Lei RY, Leonard CE, Howell KT, et al. Four-year clinical update from a prospective trial of accelerated partial breast intensity-modulated radiotherapy (APBIMRT). Breast Cancer Research and Treatment. 2013;140(1):119-133. doi:10.1007/s10549-013-2623-x.

4. Jacobson GM, Siochi RA. Low-Energy Intraoperative Radiation Therapy and Competing Risks of Local Control and Normal Tissue Toxicity. Frontiers in Oncology. 2017;7:212. doi:10.3389/fonc.2017.00212.

5. Whelan TJ, Olivotto I, Parpia S, et al. Interim toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation (APBI) using 3D conformal external beam radiation therapy (3D CRT) Int J Radiat Oncol Biol Phys. 2013;85:21–22. DOI: 10.1200/JCO.2013.50.5511

6. Keshtgar MRS, Williams NR, Bulsara M, et al. Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomized controlled trial. Breast Cancer Res Treat. 2013;140:519–525. DOI: 10.1007/s10549-013-2641-8.

7. Akhtari M, Abboud M, Szeja S, et al. Clinical outcomes, toxicity, and cosmesis in breast cancer patients with close skin spacing treated with accelerated partial breast irradiation (APBI) using multi-lumen/catheter applicators. Journal of Contemporary Brachytherapy. 2016;8(6):497-504. doi:10.5114/jcb.2016.64830.

8. RTOG Foundation. RTOG/EORTC Late Radiation Morbidity Scoring Schema. Available online: https://www.rtog.org/ResearchAssociates/AdverseEventReporting/RTOGEORTCLateRadiationMorbidityScoringSchema.aspx.

9. Correa C, et al. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-based Consensus Statement. Practical Radiation Oncology 2017, Issue 7. DOI: 10.1016/j.prro.2016.09.007.

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

Ovarian Cancer: What Are the Treatment Options?

By Lea Simms and Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund

Ovarian cancer is the 5th leading cause of cancer death in women in the U.S. Approximately 21,000 women will receive a new diagnosis of ovarian cancer in 2015. [1]

Ovarian cancer begins in or near the ovaries, which is part of the female reproductive system. There are two ovaries, one on either side of the uterus, connected to the uterus by the fallopian tubes. Ovarian cancer is often undetected until it has spread to the uterus, pelvis, and abdomen.[2]

Like all cancers, treatment is much more successful in the early stages when the cancer has not yet spread.[3] Women over the age of 55, women who have a family history of breast or ovarian cancer, and women who have had trouble getting pregnant or have never been pregnant are all at increased risk for ovarian cancer.[4]

To find out more about who is at risk and what to do about it, see our article Ovarian Cancer: who should be concerned and what can they do?

Traditionally, there have been three different types of ovarian cancer described:[5]

  • Epithelial
  • Germ cell
  • Stromal

Epithelial tumors are the most common type: 85%-90% of all ovarian cancers are epithelial.[2]These tumors start from the layer of cells that cover the outside of the ovaries or line the inside of the fallopian tubes, and can then spread to other parts of the body. There are four different types of epithelial ovarian cancer: serous (the most common), mucinous, endometroid, and clear cell. These different types of epithelial cancer describe how the tissue looks under the microscope and also the behavior of the cancer.

Germ cell tumors are a rarer form of ovarian cancer, in which the tumor starts growing in the germ cells that produce the eggs. Germ cell tumors make up about 2% of ovarian cancer cases and have a very high survival rate of 90%.[2] This type of cancer is most commonly seen in women under 25 years old (ovarian cancer research fund). There are several types of germ cell tumors: teratomas, dysgerminomas, endodermal sinus tumors, and choriocarcinomas.

There are also stromal tumors which begin in the tissue cells that hold the ovary together. Stromal tumors are diagnosed in about 1% of women with ovarian cancer and have a high survival rate of 75%.[2]

Like most cancers, ovarian cancer is probably not a single disease, but is made up of several different types of cancer that start in different places in or near the ovaries. Each type of cancer has its own unique genetic make-up, place where it begins to grow, and way of spreading. For example, the most common form of ovarian cancer, high-grade serous carcinoma, is now thought to start in the fallopian tube instead of the ovary [6]. New treatments for ovarian cancer are in the early stages, but the goal is to develop treatment options for these specific types of ovarian cancer.

Benign ovarian tumors are not cancerous and can be treated by removal of all or a part of an ovary. Tumors that are cancerous can metastasize (spread) and can be fatal. The stage of the tumor is used to describe how much it has spread ranging from stage I (only within the ovary or fallopian tube and has not yet spread) to stage IV (has spread to outside organs like the liver or lungs). The grade classifies the tumor on how much it looks like normal tissue: 1 is the most like normal tissue and 3 is the least like normal tissue. These classifications are used to determine what treatment is recommended.[1]

Treatments

If you were diagnosed with ovarian cancer, your medical team will recommend one or more treatment options. The main treatments for ovarian cancer are:

The most common recommendation for all stages of ovarian cancer is surgery followed by chemotherapy.[1]

Surgery

Surgery for epithelial ovarian cancer has two main goals: to stage and debulk (remove) the tumor. Staging refers to the doctors looking to see how far the cancer has spread and then taking tissue samples to test in a lab. Usually this means the doctor will remove the ovaries, uterus, cervix, fallopian tubes and omentum (fatty tissue around these organs), and then remove tissue and fluid samples from the abdominal cavity and pelvis.[1] The surgeon will then remove as much of the tumor as possible, which is called debulking. If the disease seems to be limited to one or both ovaries, the surgeon will biopsy the pelvis and abdomen to find out if the cancer has spread. Sometimes debulking is not possible because the patient is not healthy enough or the tumor may be attached to other organs. In these cases, chemotherapy will be used to treat the cancer that can’t be surgically removed.[1]

Research has shown that if the cancer is caught early enough, a woman can be safely treated without removing her uterus (read more about it http://dev.stopcancerfund.org/p-ovarian-cancer/patients-under-50-with-early-stage-ovarian-cancer-safe-treatment-with-no-loss-of-fertility/).  Women with later stage ovarian cancer usually must undergo surgery that removes the uterus and thus causes infertility.[7]

For germ cell tumors and stromal tumors the main goal of surgery is to remove the cancer. Germ cell tumors are usually treated with a hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy (removal of ovaries and fallopian tubes). If the cancer is found in one ovary, then only one of the ovaries and a fallopian tube will be removed to preserve the woman’s fertility. Stromal tumors are treated by removing the cancerous ovary, unless the cancer has spread to other areas, in which case a hysterectomy or bilateral salpingo-oophorectomy will be performed.[1]

Chemotherapy

After surgery, patients with epithelial ovarian cancer are treated with chemotherapy. Typical chemotherapy is a combination of 2 or more drugs, every 3-4 weeks, with 3-6 cycles. A cycle is a schedule of regular doses of drugs followed by a rest period.[2]

The chemo drugs are given by mouth, injected into a vein (Intravenous chemotherapy also known as IV), or injected through a catheter directly into the abdomine (called intraperitoneal chemotherapy or IP). IP therapy works by bringing the toxic drugs in a concentrated form to exactly where the cancer is, while IV therapy aims to kill cancer cells wherever they might be located.[5] In 2006, researchers reported that on average, patients receiving IP chemotherapy lived 65 months, compared to 50 months for patients receiving IV chemo only [8]. That is why the National Cancer Institute currently recommends IP administration of chemo to treat ovarian cancer. However, this recommendation may soon change. In 2016, a study of 1,560 ovarian cancer patients surprisingly found no difference in survival for women receiving IP chemo compared to other traditional methods [9]. This is important because IP therapy tends to  cause worse side effects.[5]

Although IP and IP/IV administration has been shown to have benefits and has been recommended by the National Cancer Institute, the combination tends to have worse side effects.[5] That is probably why most eligible patients do not receive a combination of IP and IV chemotherapy.[7]

There are many different types of chemotherapy drugs and research has shown that giving a combination of drugs in the initial treatment of ovarian cancer is more effective.[10] Most doctors prescribe a platinum compound such as cisplatin or carboplatin and a taxane compound such as paclitaxel or docetaxel.[1] A very large study in 2006 compared 198 clinical trials of 48,440 women being treated for ovarian cancer and found that the regimen that best prolonged survival is a platinum and taxane combination with intraperitoneal administration.[8]

Hormone Therapy

Hormones or hormone-blocking drugs can stop the growth of tumors. Tamoxifen is an anti-estrogen drug that is common in the treatment of breast cancer and some ovarian stromal tumors.[1] There have been no large studies of Tamoxifen for ovarian cancer, however.  It is generally used as a second-line therapy for recurrent stromal tumors or tumors that do not respond to standard chemotherapy. Since side effects are generally mild, it is considered a less toxic choice for women who cannot tolerate the side effects of standard chemotherapy. However, tamoxifen can increase the risk of serious blood clots in the legs, so patients should be aware of this risk before considering it.[1]

Targeted Therapy

Targeted therapy uses genetically engineered drugs such as bevacizumab (Avastin) and olaparib (Lynparza) to attack the cancer cells. In several studies, Avastin has been shown to have some effectiveness in delaying the progression of ovarian cancer but it is not clear whether it helps patients live longer, and it has substantial side effects that can harm quality of life.[11][12]

Olaparib (Lynparza) is approved by the FDA for the treatment of ovarian cancer in women with BRCA1 or BRCA2 mutations as a last resort for women who have had three or more prior unsuccessful treatments of chemotherapy.[13]  It has not been proven safe or effective for other ovarian cancer patients, but two studies are underway to see if the drug can be a useful treatment for women with BRCA mutations who have previously tried at least one platinum-based chemotherapy treatment.[14][15]

Radiation Therapy

Radiation therapy is not common for ovarian cancer.  Radiation therapy uses high energy x-rays or particles to kill the cancer cells.  It is sometimes used for recurrent cases when the cancer is confined to a small area.[2]

Which types of treatment you and your doctor decide to go with depends on the type of ovarian cancer you have and how it has advanced.

Clinical Trials

Clinical trials are used to help find new treatments for cancer.[2] If more effective treatments are found through clinical trials, they may become the standard treatment. If the new treatment is found to be less effective or have worse side effects, it probably will not be approved by the FDA and will not be available in the future.  Patients can enter clinical trials at different stages of their cancer treatment, but some trials may only be open to patients who have not yet started treatment. Remember: the treatments tested in clinical trials are not proven to be effective and the side effects are often unknown.  The new treatment may be worse than standard treatments, better, or identical in terms of effectiveness or side effects.  For those reasons, clinical trials are usually chosen by patients who have no other good options for treatment.  See here for the National Cancer Institute’s list of clinical trials: http://www.cancer.gov/about-cancer/treatment/clinical-trials.

The Latest Research

New research suggests that the most common route of treatment (first surgery, then chemo) might not be the most effective route of treatment. There is now evidence that having chemotherapy first, then followed by surgery, may be more effective for women with ovarian cancer, especially with epithelial ovarian tumors.[16]  Research has shown that chemotherapy prior to surgery improved the debulking of the tumor[17][18] and that patients also had fewer surgical complications and better post-operative recovery.[19]

The latest research, by Dr. Sean Kehoe and his team of doctors, took place in 87 hospitals in the UK and New Zealand.[18] The study randomly assigned 552 women with stage III or IV ovarian cancer to either the “Primary Surgery Group” (surgery followed by 6 cycles of chemotherapy) or to the “Primary Chemotherapy Group” (3 cycles of chemotherapy, then surgery followed by 3 more cycles of chemotherapy). The study measured overall survival rate as well as progression free survival (delaying the spread of cancer) and quality of life. At the conclusion of the study, 231 patients in the primary surgery group had died as had 220 in the primary chemotherapy group. Although the number of patients that died was similar, the Primary Chemotherapy group lived 1.5 months longer on average and had fewer adverse side effects and fewer toxic effects than the Primary Surgery group. The median survival rate (how long they lived after treatment) for the Primary Surgery group was 22.6 months compared to 24.1 months for the Primary Chemotherapy group. These results are also consistent with observational studies that showed similar results in survival rates.[20]

Although the differences in survival rate and duration of survival were similar, the chemotherapy group did have marginally better outcomes. This new finding may change the way doctors treat ovarian cancer and gives women another option rather than immediate surgery.

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

References

  1. How is ovarian cancer treated? (2015, March 12). Retrieved June 8, 2015, from http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-treating-general-info
  2. Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. (n.d.). Retrieved June 8, 2015, from http://www.cancer.gov/types/ovarian
  3. Ovarian cancer. (n.d.). Retrieved June 16, 2015, from http://www.mayoclinic.org/diseases-conditions/ovarian-cancer/basics/definition/con-20028096
  4. Waghray, P. (n.d.). Ovarian cancer: Who should be concerned and what can they do? Retrieved August 12, 2015, from http://dev.stopcancerfund.org/uncategorized/ovarian-cancer-who-should-be-concerned-and-what-can-they-do/
  5. Types of Ovarian Cancer. (n.d.). Retrieved June 16, 2015, from http://www.ocrf.org/about-ovarian-cancer/what-is-ovarian-cancer/types-of-ovarian-cancer
  6. Perets  R, Drapkin  R.  It’s totally tubular… riding the new wave of ovarian cancer research. Cancer Res. 2016;76(1):10-17.
  7. Bromberg, J. (n.d.). Patients under 50 with early-stage ovarian cancer: Safe treatment with no loss of fertility. Retrieved August 12, 2015, from http://dev.stopcancerfund.org/p-ovarian-cancer/patients-under-50-with-early-stage-ovarian-cancer-safe-treatment-with-no-loss-of-fertility/
  8. Armstrong DK, Bundy B, Wenzel L, et al. Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer. N Engl J Med. 2006; 354:34-43.
  9. Walker JL, Brady, MF, Wenzel L. A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study. Annual Meeting on Women’s Cancer. March 19-22, 2016. San Diego, CA. Presentation.
  10. Kyrgiou, M, G Salanti, N Pavlidis, E Paraskevaidis, and JPA Ioannidis. n.d. “Survival benefits with diverse chemotherapy regimens for ovarian cancer: Meta-analysis of multiple treatments.” Jnci-Journal Of The National Cancer Institute 98, no. 22: 1655-1663. Science Citation Index, EBSCOhost (accessed August 12, 2015).
  11. Garcia A, Singh H. Bevacizumab and ovarian cancer. Ther Adv Med Oncol. 2013; 5(2): 133–141. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3556875/
  12. Li, J., Zhou, L., Chen, X., & Ba, Y. (2015). Addition of bevacizumab to chemotherapy in patients with ovarian cancer: a systematic review and meta-analysis of randomized trials. Clinical & Translational Oncology: Official Publication of The Federation of Spanish Oncology Societies And of The National Cancer Institute of Mexico.
  13. Lynparza (Olaparib) label. (2014, December 1). Retrieved August 13, 2015, from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162
  14. Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1). (2013, April 30). Retrieved August 13, 2015, from https://www.clinicaltrials.gov/ct2/show/NCT01844986
  15. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy. (2013, June 7). Retrieved August 13, 2015.
  16. Bristow RE, Chi DS. Platinum-based neoadjuvant chemotherapy and interval surgical cytoreduction for advanced ovarian cancer: a meta-analysis. Gynecol Oncol 2006; 103: 1070–76.
  17. Vergote I, De Wever I, Tjalma W, Van Gramberen M, Decloedt J, van Dam P. Neoadjuvant chemotherapy or primary debulking surgery in advanced ovarian carcinoma: a retrospective analysis of 285 patients. Gynecol Oncol 1998; 71: 431–36.
  18. Kang S, Nam BH. Does neoadjuvant chemotherapy increase optimal cytoreduction rate in advanced ovarian cancer? Meta-analysis of 21 studies. Ann Surg Oncol 2009; 16: 2315–20.
  19. Hou JY, Kelly MG, Yu H, et al. Neoadjuvant chemotherapy lessens surgical morbidity in advanced ovarian cancer and leads to improved survival in stage IV disease. GynecolOncol 2007; 105: 211–17.
  20. Kehoe, S., Hook, J., Nankivell, M., Jayson, G., Kitchener, H., Lopes, T., . . . Swart, A. (n.d.). Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): An open-label, randomised, controlled, non-inferiority trial. The Lancet.

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!

Can Taking Fish Oil Supplements Help Lung Cancer Patients Undergoing Chemotherapy?

Katherine Ip, Cancer Prevention and Treatment Fund

Fish oil is a well-known dietary supplement that is likely to reduce the risk of getting heart disease. More research is needed to find out if it may also reduce high blood pressure, menstrual pain, the risk of stroke, and the symptoms of arthritis, bipolar disorder and ADHD.[1]

Some studies have suggested that fish oil and the omega-3 fatty acids it contains might also help improve the effectiveness of chemotherapy for cancer patients, while reducing the bad side effects.  The types of chemotherapy tested include anthracyclines, cisplatin, irinotecan, and alkylating agents. Only two studies were done on humans, and the others were done on animals or cancer cells in test tubes.[2]

Fish Oil Supplements, Lung Cancer, and Chemotherapy

Late-stage non-small cell lung cancer (NSCLC) is usually treated with chemotherapy, but chemotherapy is often ineffective.[3] And, the current treatments have very unpleasant side effects that can severely harm the quality of a patient’s life, so researchers are always looking for ways to minimize damage to the body’s healthy cells while still attacking cancer cells with full force.[4]

In 2011, a very small study by researchers from Canadian Universities looked at whether fish oil could help chemotherapy patients with non-small cell lung cancer (NSCLC) that has spread to the lymph nodes or to other parts of the body (Stage III and Stage IV).[5] Patients with these late stages of lung cancer, on average, only live about 2 years after being diagnosed.

Since the cancer had already spread, all the patients were given the same palliative chemotherapy, aimed at reducing cancer symptoms and improving the patient’s quality of life, rather than curing the patient. Researchers only included lung cancer patients who had never had chemotherapy before. Only 15 of the patients were given fish oil and 31 were not. When they started their chemotherapy, the patients in the group taking fish oil had a choice of taking four capsules a day (each with 1 gram of fish oil), or 7.5 milliliters of actual fish oil, which provides the same amount of omega-3 fatty acids.

How did Fish Oil Affect Survival?

The patients who took fish oil responded much better to chemotherapy than those who didn’t. Their tumors shrank more in size or shrank more quickly, and they were almost twice as likely to be alive a year after treatment compared to the patients who didn’t take fish oil (60% compared to 39%). These results held true regardless of how old the patient was, whether the patient was a man or woman, and how much muscle mass the patient had.  The latter is important because patients with lower muscle mass tend to suffer from more negative side effects from chemotherapy.

Patients who did not take fish oil were more likely to have their cancer get worse after two cycles of chemotherapy than patients who took fish oil. And, more of the patients who took fish oil were able to complete all of their planned chemotherapy, because they experienced less side effects for the same levels of chemotherapy as patients who did not take fish oil. Since the patients who took fish oil felt well enough to receive more cycles of chemotherapy, their tumors also shrank more and they lived longer.

Did Fish Oil Affect Quality of Life?

When chemotherapy kills the body’s healthy cells (think of it like “friendly fire”), it can cause side effects such as nausea, vomiting, and constipation, and it also lowers the body’s ability to fight infection. Since the patients taking fish oil were able to complete more cycles of chemotherapy, we would expect them to have worse side effects. Instead, the side effects listed above were about the same for patients taking fish oil and those that did not. The researchers suspect that the reason why is that fish oil protected the healthy cells from the chemotherapy, but not the cancer cells. Their findings are consistent with a study where mice with lung cancer responded better to treatment when fed fish oil.[6] They are also consistent with a study in which breast cancer patients responded better to chemotherapy when their breast tissue had a higher concentration of DHA, one of two fatty acids found in fish oil.[7]

Is There a Catch?

The study of fish oil and lung cancer included only 31 patients not taking fish oil and 15 patients taking fish oil. Such a small study does not provide adequate evidence, but it does mean more research is warranted.

The Bottom Line:

In this one small study, taking fish oil supplements appears to help late stage lung cancer patients tolerate their chemotherapy better so that they can get the most benefit from it.  And, fish oil is inexpensive and has no known risks. More research is needed to find out if fish oil is usually effective for lung cancer patients and possibly other cancer patients. Since fish oil is very safe, if you or someone you know is about to start chemotherapy, it’s probably a good idea to start taking fish oil supplements right away.

References:

  1. Natural Medicines Comprehensive Database. Omega-3 Supplements: Medline Plus supplements. 2012. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/natural/993.html. Accessed February 4, 2013.
  2. Bougnoux P, Hajjaji N, Ferrasson MN, Giraudeau B, Couet C, Le FO. Improving outcome of chemotherapy of metastatic breast cancer by docosahexaenoic acid: a phase II trial. Br J Cancer. 2009; 101: 1978-1985.
  3. Pujol JL, Barlesi F, Daures JP. Should chemotherapy combinations for advanced non-small cell lung cancer be platinum-based? A meta-analysis of phase III randomized trials. Lung Cancer. 2006; 51: 335-345.
  4. Carney DN. Lung cancer–time to move on from chemotherapy. N Engl J Med. 2002; 346: 126-128.
  5. Murphy RA, Mourtzakis M, Chu QSC, Varacos VE, Reiman T, & Mazurak VC. Supplementation with fish oil increases first-line chemotherapy efficacy in patients with advanced nonsmall cell lung cancer.
  6. Yam D, Peled A, Shinitzky M. Suppression of tumor growth and metastasis by dietary fish oil combined with vitamins E and C and cisplatin. Cancer Chemother Pharmacol. 2001; 47: 34-40.
  7. Bougnoux P, Germain E, Chajes V, et al. Cytotoxic drug efficacy correlates with adipose tissue docosahexaenoic acid level in locally advanced breast carcinoma. Br J Cancer. 1999; 79: 1765-1769.

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

Lung Cancer and African Americans

Sarah Miller, RN, Cancer Prevention and Treatment Fund

For years, doctors and medical researchers have been puzzled by the fact that African-Americans are more likely to die from lung cancer than people of any other race or ethnicity, although they are not more likely to smoke. How could this be? Is it because they don’t get diagnosed and treated in time, is it genetic, or is there something else going on? Research indicates that a combination of factors may be responsible for the unequal rates of death from lung cancer.

The Problem

African-Americans are disproportionately affected by lung cancer. The percentage of African-American men diagnosed with lung cancer each year is at least 30% higher than among white men, even though they have similar rates of smoking as white men. In fact, African-American men tend to smoke fewer cigarettes per day than white male smokers. While African-American women are less likely to smoke than white women, they are about as likely to develop lung cancer and die from lung cancer as white women. African-Americans also tend to be diagnosed with lung cancer at a younger age. Research has examined many possible explanations for these differences.

Is it Genetic?

Scientists have recently identified several genes that are linked to lung cancer. People who have these genes and smoke are more likely to develop lung cancer than other smokers. They have also found genes that cause a person to metabolize nicotine differently, which could be a factor in whether a person develops lung cancer.6 Some of these genes have been found to be more common in people with African ancestry. This suggests that genetics may have a role in the higher rates of lung cancer among African-Americans.

Genetics are only a part of the equation, though. There are many other factors that contribute to differences in lung cancer rates and in death from lung cancer.

Does the Type of Cigarettes Matter?

Tobacco companies have a long history of targeting the African-American community with advertisements for menthol cigarettes. As a result, about 80% of African-American smokers smoke menthol cigarettes, compared with only 20% of white American smokers.

Many researchers have tried to find a link between lung cancer and menthol cigarettes. Some have theorized that the “cooling” effect of menthol cigarettes allows menthol smokers to inhale the smoke more deeply, which could cause more damage to their lungs. Others have speculated that menthol cigarettes might be more addictive than regular cigarettes.

While studies have shown that smokers of menthol cigarettes may have a more difficult time quitting, and are more likely to smoke their first cigarette sooner after waking in the morning than people who smoke regular cigarettes, researchers have not been able to find any chemical properties of menthol cigarettes that make them more addictive.

Smokers of menthol cigarettes do not, on average, smoke any more cigarettes in their lifetime than regular cigarette smokers, and research so far has failed to show that menthol cigarettes cause more cases of cancer than other kinds of cigarettes.

The one obvious problem with menthol cigarettes is that the menthol makes cigarette smoke less harsh for first-time smokers. Because, of this, many young teens smoke them. In fact, while smoking is declining among adults and adolescents, menthol cigarettes are becoming increasingly popular among both adults and kids ages 12-17. Since we know that people who begin smoking at younger ages are more likely to become regular smokers, it is troubling that there is a product available that helps teens to start smoking. Although African-American teens start smoking later than white teens, they disproportionately smoke menthol cigarettes.

Does the Environment Affect Lung Cancer Disparities?

Industries that produce heavier air pollution (for example, factories, oil refineries, and chemical plants) are often located in African-American communities. Exposure to pollution from working in or living near these industries can increase a person’s risk for lung cancer.,

A person who smokes and is exposed to air pollution is at higher risk for lung cancer than a smoker who is not exposed to air pollution. People who are exposed to air pollution on the job are at especially high risk. The fact that these polluting industries are frequently located in African American communities and employ members of that community may also help to explain why African-Americans are disproportionately affected by lung cancer.

Is it Because of Differences in Treatment?

While differences in diagnosis and treatment don’t explain why more African-Americans develop lung cancer, it may help to explain the higher death rate from lung cancer among blacks.

One study of all the lung cancer patients in the Florida Cancer Registry found that the survival time for African-American patients diagnosed for lung cancer was shorter than that of white patients. The researchers also found that the entire difference in survival time between African-Americans and whites could be attributed to the fact that white patients tended to get more timely and appropriate treatment.

They concluded that if African-American patients could begin treatment as early as white patients, and were provided the best treatment for their condition, then their survival time would catch up with that of white patients.

Another study found that many patients with a certain type of lung cancer, for which surgical removal of part of the lung offers the best chance for a cure, did not get the proper surgery. Shockingly, only 62% of all patients who would have a good chance of the surgery helping them had the surgery. When the researchers separated the results out by race, 66% of white patients who were appropriate candidates had the surgery while only 55% of African-American patients who were appropriate candidates had the surgery. While this is bad news for all patients with this type of lung cancer, it is worse news for African-Americans since they were substantially less likely than white patients to get the surgery.

Why Don’t African-American Patients Receive the Proper Treatment?

One reason that African American patients are less likely to receive the proper treatment than white Americans may be that they are less likely to have health insurance. While about 13% of white American adults under the age of 65 are uninsured, 21% of African American adults in the same age group are without health insurance. Uninsured patients may decide against treatment because they can’t afford it, or may have a difficult time finding a hospital that is willing to provide the treatment to uninsured patients.

Another reason that African American patients do not always receive the most appropriate care is that there seem to be communication problems between providers and patients.

Studies have found that the type of communication a patient has with a doctor or health care provider has an impact on his or her decision-making about treatments. In the long-term, this has a huge impact on the state of a person’s health.

Health care providers are increasingly pressured to fit more patient visits into shorter time periods. Because of this, providers have less time to spend getting to know each patient. In this type of situation, people tend to make snap judgments.

Providers make a judgment based on their first impression of a person (what they think of that person after glancing at his or her chart and based on personal appearance). This judgment influences the provider’s judgment about what medical information the patient wants or doesn’t want, what type of treatment the patient is likely to find acceptable, and how reliable the person will be with his or her follow-up care.

Patients, too, know that they have only a short time for an appointment. They also may judge a provider based on his or her appearance and make assumptions. They may assume that the provider is very knowledgeable and that they should just do what the provider says. Patients may also assume, based on a snap judgment, that the provider will not respond well to being asked questions, that the provider does not care about the patient, or that the provider is not going to be helpful.

Research has shown that when the provider is of a different race or culture than the patient, these breakdowns in communication are more severe and have more negative results in terms of the quality of care a patient receives.

What is Being Done to Reduce Disparities in Lung Cancer Survival?

While healthcare providers and lawmakers recognize that this is a serious problem, they also recognize that there is no quick fix.

One step that is being taken by medical schools is to try and attract more African-American students. Currently, African-Americans are under-represented in the medical profession. The assumption is that African-American physicians be able to communicate more effectively with African-American patients, and that they will be able to educate their colleagues to do so as well.

Many people are also trying to limit advertising of menthol cigarettes, especially ads that target African-American teens.

Some public health advocates are urging the FDA to ban menthol in cigarettes. Other flavored cigarettes (“bidis”) have already been banned on the principle that they attract teens to smoking and make cigarettes more tolerable. Since we know that menthol also makes smoking more desirable for teens, and since it is a flavoring for cigarettes, it makes sense that it should be banned along with the other flavors. Banning menthol cigarettes would likely reduce the number of African-American teens that smoke, and might help reduce lung cancer deaths among African-American men and women.

References:

Centers for Disease Control and Prevention; Summary Health Statistics for US adults: National Health Interview Survey, December 2008; Vital and Health Statistics, 10 (242), 2009.

Stellman, SD; Chen, Y; Mucsat, JE; Djordjevic, MV; Richie, JP; Lazarus, P; Thompson, S; et.al. Lung Cancer Risk in White and Black Americans.  Annals of Epidemiology. 2003. 13(4). Pp.294-302.

National Cancer Institute; SEER stat fact sheets: Lung and Bronchus. Surveillance Epidemiology and End Results. 2010. Retrieved from: http://seer.cancer.gov/statfacts/html/lungb.html#incidence-mortality

American Lung Association; Too May Cases, Too Many Deaths: Lung Cancer in African-Americans, 2010. Retrieved from http://www.lungusa.org/assets/documents/publications/lung-disease-data/ala-lung-cancer-in-african.pdf  on August 10, 2010.

Hansen HM, Xiao Y, Rice T, Bracci PM, Wrensch MR, Sison JD, Chang JS, et. al; Fine mapping of chromosome 15q25.1 lung cancer susceptibility in African-Americans. Human Molecular Genetics.2010 (Epub ahead of print)

Amos CI, Gorlov IP, Dong Q, Wu X, Zhang H, Lu EY, Scheet P, Greisinger AJ, Mills GB, Spitz MR. Nicotinic acetylcholine receptor region on chromosome 15q25 and lung cancer risk among African-Americans: a case-control study. J Natl Cancer Inst. 2010.102(15):1199-205.

Yerger, VB; Przewoznik, J; & Malone. RE; Racialized Geography, corporate activity, and health disparities: Tobacco industry targeting of inner cities. J Health Care Poor Underserved. 2007;18(4 Suppl):10-38.

Okuyemi KS; Ebersole-Robinson M; Nazir N; & Ahluwalia JS; African-American menthol and nonmenthol smokers: differences in smoking and cessation experiences. J Natl Med Assoc. 2004;96(9):1208-11.

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