Advanced Prostate Cancer--Trials Don't Live Up to Expectations

 Dr. Tom Beer and Dr. Joshi Alumkal, of Oregon Health and Science University,  published an editorial in the July 12, 2016 issue of the Journal of Clinical Oncology questioning the value and accuracy of recent Clinical Trials using Docetaxel (a chemotherapy drug) to control symptoms and prolong life in metastatic castration-resistant prostate cancer (mCRPC) patients. Here are some of the topics they covered.

Since 2004 numerous Phase III clinical trials have used Docetaxel as one part of clinical trials looking for survival advantage in men with advanced prostate cancer. More than half of the trials failed to produce positive results and others produced very weak results. The authors explore how and why this has happened.

Some trials produce 'statistical' success (e.g. significance)  but not much 'clinical' benefit (e.g. a survival benefit of only a month or two). With such a high rate of Phase III failures, it makes sense to change the design of these clinical trials. The authors suggest:

1    Include the patient in the planning process. What do these men want and expect? What would be a positive outcome for them? What would make them want to volunteer for a clinical trial?

2    Identify and focus on patients most likely to benefit from a particular drug or treatment. Then design small studies including only those patients.

3    Determine what success is--improvement in survival, better quality of life, lower risk of toxicity, etc.

There have been too many failures in mCRPC phase III clinical trials to justify continuing the same procedures again and again. Trials are costly, patients are exposed to potentially toxic agents with little benefit, and marginally effective drugs may be moved toward approval. Studies should focus on providing the greatest likelihood of significantly improving the lives of patients.



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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

Clinical Trial stopped early for Breast Cancer Drug Ibrance®

Another clinical trial success story

 

Ibrance® (palbociclib) trials were halted early by its creator Pfizer when it met its primary endpoint—a statistically significant improvement in progression-free survival in postmenopausal women with HR+, HER2 metastatic breast cancer. This has been a particularly difficult cancer to treat.

Pfizer announced in an April, 15, 2015 press release:

IBRANCE was approved by the U.S. Food and Drug Administration (FDA) in February 2015 as a first-line treatment for women with advanced or metastatic estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. IBRANCE® (palbociclib), in combination with letrozole, is indicated for the treatment of postmenopausal women with ER+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled. IBRANCE is not approved for the use being investigated in PALOMA-3 or for any indication in any market outside the U.S.

The trials were conducted in more than 150 global sites. Although the FDA has approved Ibrance®, the Phase III studies are ongoing. The combination of Ibrance® plus letrozole extended progression-free survival by about 50% (from 10.2 months with letrozole alone to 20.2 months with the combination) in the Phase II part of the study.

If you or somebody you know might benefit from this drug, talk to your doctors.

The American Cancer Society (ACS) estimates that more than 230,000 American women will be diagnosed the breast cancer and more than 39,000 women will die from breast cancer this year. This new drug is expected to prolong many lives.

This drug is one of the new generation of highly effective and very expensive drugs. The projected cost of Ibrance® will be $9,850 a month. This is not out of line with other recently approved cancer treatment drugs.

For more information on clinical trials, what they are, where they are, and if you might qualify to participate, go to the National Institutes of Health clinical trials site.

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