Aug 25, 2015

Cancer Clinical Trials and the Elderly—an Unlikely Combination

Did you know?

Q         What age group is most likely to have Cancer?

A         People older than 65. They represent 13% of the population and more than 60% of all those with cancer.

Q         Who is most likely to die of cancer?
A         Seniors. About 80% of all cancer deaths occur in those older than 65.

Q         What age group is least likely to be represented in cancer clinical trials?
A         Seniors. 

Q         Can seniors respond to cancer medications in a different way than younger patients? (For example, having more toxic side effects.)
A         Yes

Q         So, WHY are seniors with cancer not included more in clinical trials?
A         It’s a long story……

Improving the research base for treating older adults with cancer was a focus of the 2015 ASCO conference. An expert panel presented the problem and possible solutions. The Journal of Clinical Oncology reprinted the complete report and recommendations.

Factors such as meeting eligibility requirements can create hurdles. Many older patients are limited in mobility, have numerous previous treatment regimens, have a more limited predicted lifespan, and take multiple medications (the average is more than 9 for patients over 65). Multiple medications can interfere with trial medications. More than 80% of older patients have a chronic condition (such as diabetes or arthritis) which can complicate cancer treatment. 

Doctors often do not even recommend older patients for inclusion in clinical trials, although Doctor recommendation is the number one predictor of older people choosing to participate in clinical trials.

Many oncologists, such as Stuart Lichtman, MD, Memorial Sloan Kettering Cancer Center in NY, believes that seniors with cancer are being short changed when it comes to cancer treatment because they are under-represented in research.

ASCO makes five recommendations to improve evidence generation in the 65+ population:

(1) Use clinical trials to improve the evidence base for treating older adults (older than 65) with cancer,

(2) Leverage research designs and infrastructure for generating evidence on older adults with cancer (change trial requirements to fit older patients),

(3) Increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer,

(4) Increase clinicians' recruitment of older adults with cancer to clinical trials (educate doctors to recommend older patients for trials), and

(5) Use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.

Doctors currently have no choice but to use results from clinical trials conducted with people in their 50s to treat people in their 80s.

Research results from clinical trials with older patients could provide a better scientific basis for treating cancer in the elderly. As someone who is elderly and has cancer, this author wholeheartedly supports these recommendations.

Click on the links in this article for a more comprehensive discussion of this issue.

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(c) 2012 Tom Beer and Larry Axmaker

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