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Title: Chemotherapy "Holiday" Safe for Some Men With Advanced Prostate Cancer
URL: http://www.pslgroup.com/dg/21DB32.htm
Doctor's Guide
February 26, 2008

NEW YORK -- February 26, 2008 -- In a first-of-its-kind study, researchers from the Oregon Health & Science University (OHSU) Cancer Institute have found that men with advanced prostate cancer can take a safe break from chemotherapy. The results of the study were published in Cancer.

In this double-blind, multi-institutional, randomised trial, principal investigator Tomasz Beer, MD, Grover C. Bagby Endowed Chair for Cancer Research, Director, OHSU Cancer Institute Prostate Cancer Program, Associate Professor, OHSU School of Medicine, Portland, Ore., and colleagues determined whether men with metastatic, androgen-independent prostate cancer could take a break from docetaxel. Prior to this study, it was not known whether stopping chemotherapy would lead to treatment resistance.

"We wanted to see if we could improve the quality of life for these patients by giving them time away from chemotherapy and possibly extend the time their cancer is controlled. Essentially, what we proved is that in selected subjects, chemotherapy holidays are feasible and provided meaningful breaks from treatment," said Dr. Beer.

Of the study participants (N = 250), 18 percent entered the intermittent arm of the study. These men previously had responded well to chemotherapy. The median duration of the first break from chemotherapy was 18 weeks. When chemotherapy was resumed, the majority of men responded to treatment. The results indicated that 45.5 percent of the men responded with a greater than 50 percent reduction in prostate specific antigen (PSA) from their post-holiday baseline; of those, 45.5 percent had stable PSAs for at least 12 weeks, and 9.1 percent developed disease progression.

The next step is to study the addition of immunotherapy during the breaks between chemotherapy sessions. "Because we know holidays are a good thing, we want to find ways to make them even longer," noted Dr. Beer.

OHSU and Dr. Beer have significant financial interest in Novacea, Inc., a company that has a commercial interest in the results of this research and technology. This potential conflict was reviewed and a management plan approved by the OHSU Conflict of Interest in Research Committee and the Integrity Program Oversight Council was implemented.

Source: Cancer, January 15, 2008

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