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.

 

Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Prostate Cancer Research at OHSU--Interview

 Tom's interview with Reggie Aqui at KGW Channel 8 in Portland.


He covered prostate cancer basics, risk, types, and when to get tested.

Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Advances in Prostate Cancer Treatment this Past Year-ASCO 2015

Dr. Tom Beer attended the 2015 ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago. He wrote a paper about some of the  recent discoveries and important advances in prostate cancer treatment. This is a summary of that paper. You can find the original in the Oncology Journal.

•  A trial called STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) recruited men starting hormone therapy for high-risk, locally advanced prostate cancer. Multiple arms of the study are testing the addition of various agents to standard hormonal therapy. The results of adding docetaxel, zoledronic acid, or both were reported at ASCO. Nearly 3,000 men have participated in the study. The use of docetaxel, with or without zoledronic acid, significantly increased overall survival. The bottom line‑the use of chemotherapy with hormonal therapy in patients with advanced metastatic prostate cancer was supported.

• In Radiation Therapy Oncology Group study 0521, the early use of chemotherapy was also evaluated, along with radiation and hormonal therapy, in high-risk localized disease.[2] Six hundred twelve patients with localized prostate cancer and features consistent with a high risk of relapse were treated with radiation therapy and 2 years of hormonal therapy with or without 6 cycles of docetaxel. The addition of chemotherapy resulted in an improvement in the 4-year overall survival rate and improvement in 5-year disease free survival. These results support earlier trials which found that using chemotherapy in the initial management of metastatic prostate cancer increased survival time. Additional follow-up is necessary before this becomes standard treatment.

• A French study, the GETUG-AFU 16 trial, used radiation in men with a PSA rise after a prostatectomy. A six month regimen of hormonal therapy was added for some of the patients. Progression-free survival was significantly improved in those patients receiving the combination therapy.

• How soon to begin hormonal therapy in men with rising PSA levels was the focus of another study. Men were randomly assigned to a group that started hormonal therapy in two years or four years. The overall survival rate was significantly higher in the men who began therapy at two years. A concern in using hormonal therapy is toxic side effects. Early study results suggest earlier use of hormonal therapy may save lives in spite of side effects. Larger, more definitive studies are needed to test these results.

•  A comparison of the use of intermittent hormonal therapy versus continual hormone therapy was the focus of a study conducted by the Southwest Oncology Group (SWOG). One group of older men received continual ongoing hormonal therapy and the other group intermittent treatment. Early results suggest the intermittent treatment group had more medical events over the time of the study than those on continual hormonal therapy.

• Hormonal therapy is routinely combined with radiation for the treatment of high-risk and most intermediate-risk patients. But in intermediate-risk patients, the combination is not as well studied and questions about the need for hormonal therapy have been raised. A randomized trial that involved 600 participants showed that biochemical and disease-free survival with 6 months of hormonal therapy plus radiation were superior even to results with dose-escalated radiation, providing support for the widely practiced approach of combining these two treatment modalities.

 
Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker