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Prostate cancer recommendations updated
As new data are generated to predict clinical benefit, recommendations will continue to evolve.
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The Prostate Cancer Clinical Trials Working Group has recommended that an increased emphasis be placed on time-to-event endpoints, such as failure to progress, to help make decisions when proceeding from phase-2 to phase-3 trials.
In a recent issue of the Journal of Clinical Oncology, members of the PSA Working Group presented new consensus criteria for prostate cancer trials, updating eligibility and outcome measures in trials that evaluate systemic treatment for patients who have progressive prostate cancer despite castrate levels of testosterone.
The guidelines were created by a committee of investigators following a review of previously published criteria and emerging trial data.
According to the researchers, the Prostate Cancer Clinical Trials Working Group recommends a two-objective standard, which includes controlling, relieving or eliminating disease manifestations present at the initiation of treatment and preventing or delaying disease manifestations that are expected to occur.
Updated guidelines
"The criteria originally published by the Journal of Clinical Oncology set out what we would agree upon as measures of treatment effect," Michael J. Morris, MD, of the Memorial Sloan-Kettering Cancer Center, told HemOnc Today. "During the past several years, we've recognized that those outcome measures needed to be updated.
“We were using an understanding of the disease that we’d had from several years ago, but now we recognize that there are new drugs that may not have those predictable effects on PSA, and perhaps some of those definitions that seemed reasonable then are no longer appropriate.”
The guidelines address topics such as how prostate cancers that progress despite castrate testosterone levels should be termed castration-resistant and not hormone-refractory, update eligibility criteria in order to confirm disease progression, identify distinct clinical subtypes and incorporates predictive models.
Definitions for assessable changes in PSA and bone scans were also reevaluated.
"In this set of criteria, you order a confirmatory bone scan before you take a patient off-study," Morris said. "We do not want to prematurely take patients off treatment before we feel confident that they have failed treatment."
One of the major changes, according to Morris, is the recognition that the whole concept of response may not optimally describe treatment outcomes for prostate cancer in general, especially in light of novel biologic therapies currently being developed.
“The previous criteria were written when we might have seen dramatic changes in response to hormones or chemotherapy, and you may not see those dramatic changes with biologic therapies or antiangiogenic therapies,” Morris said. “This set of criteria has a new emphasis on progression-free survival as opposed to response.”
The updated guidelines have already begun to be implemented in trials now open for enrollment following their official introduction at the 2007 ASCO meeting, according to Morris. – by Cara Dickinson
For more information:
- Scher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008;26:1148-1159.