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Cancer drugs that the Food and Drug Administration (FDA) approved last year cost a yearly average of $171,000.[1] For many cancer patients and their families, treatment may simply be unaffordable.

Alarmingly, some evidence even suggests that only a few of these treatment drugs have (legitimate) positive effects. This has Americans wondering why — with a seemingly endless stream of cancer research funding — patients still have few real and lasting answers.

The FDA’s Role in the Drug Approval Process

Drug companies (or their sponsors) must first test any new drug on animals to determine its safety and effectiveness before they can move on to human test subjects. Once positive effects are shown in animal studies, they perform human tests to determine further whether it can safely and properly treat a disease or provide a measurable health benefit,[2] i.e., extend cancer patients’ life expectancy.

Any drug company that wishes to sell a new drug in the United States must send their test results to the FDA for review. This review happens through FDA’s Center for Drug Evaluation and Research (CDER). CDER exists to ensure that generic and brand-name drugs work appropriately and offer more health benefits than known risks.[2] Moreover, the center only tests drug quality, safety, and effectiveness standards — it doesn’t perform any drug tests of its own.

The center has a designated team of pharmacologists, chemists, statisticians, and physicians who review the company’s data and proposed labeling. Such a diverse team ideally enables them to arrive at unbiased decisions. Should the CDER team confirm that the health benefits of the drug outweigh the known risks, the FDA approves it for sale.[2]

 

chemo stats

The Estimated Number of US Cancer Survivors. Note: Estimates for specific cancer types take into account the potential for a history of more than one cancer type. Source: Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD.

 

The Effect of Chemotherapy: What Cancer Drug Studies Have Found

While cancer drugs exist that have improved survival or quality of life, “many more drugs…[offer] patients only marginal benefits,” according to Dr. Vinay Prasad, assistant professor of medicine at the Oregon Health and Sciences University.[3]

A study in JAMA Otolaryngology explored the seventy-two cancer therapies were FDA approved between 2002 and 2014. Researchers found that, in comparison to older cancer drugs, these therapies only extended lung cancer patient’s lives by just over two months. Which many may argue, is still an extremely valuable amount of time.

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Researcher Diana Zuckerman published a study in JAMA Internal Medicine that looked at eighteen FDA-approved cancer drugs. Zuckerman concluded that these drugs did little to nothing in helping to extend patients’ lives.

In fact, two of the drugs (Cabozantinib-S-malate and Peginterferon alfa-2blessened their quality of life and led to symptoms such as diarrhea, fatigue, sleep disturbance, distress, and memory issues. Only one drug called Crizotinib revealed evidence of improved quality of life (i.e., in pain and fatigue).[4]

Study: How Effective is Chemotherapy?

Chemotherapy is often used in combination with other cancer treatments, but a team of researchers from Australia wanted to know exactly how much chemo contributes to patients’ survival rate. When looking at adult cancer patients’ odds of surviving at least 5 years after cancer, when only chemotherapy was used, they found that its effect was surprisingly small (data was taken from Australia and USA from 1990-2004). Compared to Australia’s 60% 5-year survival rate, the results showed an average of 2% from chemotherapy alone.

However, it’s important to note that the results vary substantially depending on the cancer type and stage – for example, while the survival rate was less than 1% for stomach cancer, it was 41.8% for testicular cancer. This is largely due to the fact that some types of cancer are more responsive to chemotherapy than others. Researchers summarized, “Overall, only 13 out of the 22 malignancies evaluated showed any improvement in 5-year survival, and the improvement was greater than 10% in only three of those 13 malignancies. The five most ‘chemo-sensitive’ cancers, namely testis, Hodgkin’s disease and non-Hodgkin’s lymphoma, cervix and ovary, accounted for 8.4% of the total incidence in Australia in 1998. In this group, the 5-year survival rate due solely to cytotoxic chemotherapy was 14%.”

Bottom line? Chemotherapy can be effective as a stand-alone treatment in chemosensitive cancers, however the total proportion of chemosensitive cancers was only 8.4% of the total cancer incidence in Australia in 1998.

The Side Effects of Chemo

Useful or not, it’s no secret that chemotherapy comes along with a number of difficult and disruptive side effects, both physically and emotionally. Some of these side effects will go away immediately after treatment has stopped, while others can last months, years, or the rest of a patient’s life:[9]

  • Damage to normal, healthy cells (especially blood-forming cells in the bone marrow, hair follicles, and cells of the mouth, digestive tract, and reproductive system)
  • Fatigue
  • Hair loss
  • Easy bruising and bleeding
  • Infection
  • Anemia
  • Nausea and vomiting
  • Appetite changes
  • Constipation
  • Diarrhea
  • Mouth, tongue, and throat problems, such as painful swallowing and sores
  • Nerve and muscle problems such as numbness, tingling, and pain
  • Skin and nail changes, such as dryness or pigment (skin color) change
  • Urine and bladder changes, kidney problems
  • Mood changes
  • Libido and sexual function changes
  • Fertility problems

“People who refused chemotherapy treatment live on average 12 and a half years longer than people who are undergoing chemotherapy… People who accepted chemotherapy die within three years of diagnosis, a large number dies immediately after a few weeks.” says Dr. Jones of the common cancer treatment of choice.

FDA: In Defense of Cancer Drug Approvals

Despite approving many promising cancer (or chemotherapy) drugs, FDA officials seem to be okay with the current lack of evidence of improved survival.

In USA Today, the director of FDA’s Oncology Center of Excellence, Dr. Richard Pazdur highlighted the fact that cancers grow at both quick and slow rates. Due to the different growth speeds, some studies take longer to see whether a new cancer drug improves survival or quality of life.

The FDA’s hope is to allow patients to benefit as soon as possible from these approved drugs. Yes, this means that there won’t always be an absolute certainty that cancer patients who take it will survive. Fortunately or unfortunately, this is a risk that some may take because cancer patients don’t have time on their side.[3]

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He also maintained that newer and more advanced targeted therapies extend patients’ lives by years instead of months in some cases. Immunotherapy, for example, stimulate patients’ immune systems to combat cancer cells. In the case of advanced melanoma patients, immunotherapy drugs have helped increase survival rates from five percent to thirty-forty percent today.[3]

Although these results may seem small in the grand scheme of things, for people like Dr. Richard Schilsky, senior vice president and chief medical officer at the American Society of Clinical Oncology, “There is a lot of excitement about these [immunotherapy] drugs and for good reason. There’s no diminishing the progress that’s been made.”[3]

 

The Numbers In Review: Cancer treatment and survivorship statistics 2016

Chemotherapy is usually the first treatment for cancers that have metastasized, but in many situations other treatments and/or combinations of treatments may be used as well.  Chemotherapy’s effectiveness as a stand alone treatment is largely dependent on several factors including the type of cancer, stage, past medical history, individual health status, etc. On June 2, 2016 the Cancer Journal for Clinicians published a thorough review of the 2016 findings in cancer treatment and survivorship statistics across the US.  The cancer treatment data was analyzed from 2 sources: the National Cancer Data Base (NCDB) and the SEER program.

Most notable is the comparison data found on specific types of cancer, and the types and combinations of various treatment methods used.

For breast cancer specifically, the report mentions how an overall improvement in survival rate is due to several factors: “The overall 5-year relative survival rate for female patients with breast cancer has improved in the past 3 decades, because of improvements in treatment (ie, chemotherapy, hormone therapy, and targeted drugs) and earlier detection through increased awareness and widespread use of mammography.[23] The 5-year, 10-year, and 15-year relative survival rates for breast cancer are 89%, 83%, and 78%, respectively.”

The following is a breakdown of female breast cancer treatment patterns by cancer stage:

chemotherapy side effects

Female Breast Cancer Treatment Patterns (%) by Stage, 2013. BCS indicates breast-conserving surgery; chemo, chemotherapy (includes immunotherapy and targeted therapy); RT, radiation therapy. Source: National Cancer Data Base, 2013.

For muscle-invasive bladder cancers the following breakdown of treatment patterns was:

chemo side effects

Muscle-invasive Bladder Cancer Treatment Patterns (%), 2013. Chemo indicates chemotherapy (includes immunotherapy and targeted therapy); RT, radiation therapy; TURBT, transurethral resection of the bladder tumor. Source: National Cancer Data Base, 2013.

For Nonsmall cell lung cancer the following treatment patterns were found:

Nonsmall Cell Lung Cancer Treatment Patterns (%) by Stage, 2013. Chemo indicates chemotherapy (includes immunotherapy and targeted therapy); RT, radiation therapy. Source: National Cancer Data Base, 2013.

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These stats and treatment patterns help highlight the range of treatment methods available, as well as the importance of understanding that different types of cancer respond to chemotherapy differently.  Finally, it also helps show that often more than one treatment method is used, not just chemotherapy alone.

The Importance of Cancer Survivors’ Quality of Life

As of January 1, 2016, America had over fifteen-and-a-half million cancer survivors. By 2026, research suggests that America will have over twenty million cancer survivors.[5] According to the American Cancer Society’s Facts and Figures (2016-2017), one of their goals is to provide the highest possible quality of life for patients during and after treatment.

When we think about a person’s quality of life, there are many things to consider:

  • physical well-being
  • emotional (or psychological) well-being
  • social well-being
  • spiritual well-being.[5]

And as you read the stats below, it is clear that, while peoples’ quality of life is absolutely important, it can look different from person to person.

Quality of Life Statistics

  • 25% percent of cancer survivors report a decreased quality of life due to physical problems
  • 10% report the same, but due to emotional problems [6]
  • Long-term cancer survivors (five years or more) report a similar emotional well-being to those with no history of cancer
  • Many long-term cancer survivors report a significantly lower physical well-being compared to their peers[7]
  • In the long-term, people who went through more aggressive and invasive treatments report an overall poorer functioning and quality of life[8]

So, while the FDA may approve some cancer drugs (or chemotherapy drugs) that end up being ineffective, they also take ones off the market if the life-threatening side effects outweigh the health benefits. There are a lot of cases wherein people aren’t necessarily upset with the side effects but rather, how little extra time a drug seems to give them (i.e., only months).

However, highly targeted treatments such as immunotherapy are shining hope on a dreadful disease. As technology and medicine advances, These treatments may not cure cancer, but as technology and medicine advances hopefully approved cancer drugs will significantly improve the length and quality of life.

[1] https://www.mskcc.org/research-areas/programs-centers/health-policy-outcomes

[2] http://www.fda.gov/Drugs/DevelopmentApprovalProcess/

[3] http://www.usatoday.com/story/news/nation/2017/02/09/new-cancer-drugs-do-little-improve-survival/97712858/

[4] http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2589085

[5] https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-treatment-and-survivorship-facts-and-figures/cancer-treatment-and-survivorship-facts-and-figures-2016-2017.pdf

[6] Weaver KE, Forsythe LP, Reeve BB, et al. Mental and physical health-related quality of life among U.S. cancer survivors: population estimates from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012;21: 2108-2117.

[7] Kent EE, Ambs A, Mitchell SA, Clauser SB, Smith AW, Hays RD. Health-related quality of life in older adult survivors of selected cancers: data from the SEER-MHOS linkage. Cancer. 2015;121: 758-765.

[8] Zeltzer LK, Lu Q, Leisenring W, et al. Psychosocial outcomes and health-related quality of life in adult childhood cancer survivors: a report from the childhood cancer survivor study. Cancer Epidemiol Biomarkers Prev. 2008;17: 435-446.

[9] https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/chemotherapy/chemotherapy-side-effects.html

[10] http://onlinelibrary.wiley.com/doi/10.3322/caac.21349/full

Image Sources:

https://upload.wikimedia.org/wikipedia/commons/0/0e/Chemotherapy_bottles_NCI.jpg

http://onlinelibrary.wiley.com/doi/10.3322/caac.21349/full

 

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