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Novel agent may be effective in poor-prognosis metastatic prostate cancer
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The addition of the experimental drug custirsen to docetaxel significantly extended OS in patients with metastatic castration-resistant prostate cancer who had negative prognostic factors, according to results of a phase 3 study.
The analysis included 984 men who were treated with docetaxel with or without custirsen (OGX-011, OncoGeneX) — a novel clusterin blocker — as first-line therapy.
After 509 patients had died, overall results from the SYNERGY trial indicated patients in the custirsen arm demonstrated similar median OS as patients in the control arm (23.4 months vs 22.2 months; HR = 0.93).
Kim N. Chi, MD, senior scientist at BC Cancer Agency, and colleagues hypothesized that clusterin inhibition may be more useful among a subgroup of patients with poor prognostic factors.
Thus, researchers retrospectively divided patients into good-risk and poor-risk groups using a prognostic statistical model based on commonly known risk factors in prostate cancer, including presence of liver metastasis, opioid use, Karnofsky performance status of 80 or lower, PSA of 59 ng/mL or higher, lactate dehydrogenase of 331 IU/L or higher, alkaline phosphatase of 92 U/L or higher, and hemoglobin less than 124 g/L.
That analysis included 492 patients with poor-prognosis disease. In that group, researchers reported longer median OS among those treated with docetaxel plus custirsen than those who received docetaxel alone (17 months vs. 14 months; HR = 0.73; 95% CI, 0.59-0.9).
Researchers then conducted an additional analysis of patients who had two or fewer negative prognostic factors. In this subgroup, median OS was 16 months among those who received custirsen and 13.7 months among those who received docetaxel alone (HR = 0.73; 95% CI, 0.58-0.92). – by Rob Volansky
Reference:
Chi KN, et al. Abstract 5009.
Disclosure: The researchers report employment with OncoGeneX Pharmaceuticals, as well as stock ownership in and travel accommodations from OncoGeneX and Teva.
Perspective
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Sumanta K. Pal, MD
Chemotherapy has an evolving role in advanced prostate cancer. We are starting to use it earlier on the basis of several encouraging trials. One of the challenges we have is that we have not been able to build on chemotherapy. Chi and colleagues previously reported the principal results of this study, in which there was no significant benefit of custirsen with chemotherapy. What we see here is that researchers teased out the subset of patients who receive benefit from the drug. Those tend to be patients with a poor prognosis based on laboratory-based data and clinical factors. This is an important study that points to the need to correctly select patients for these clinical trials that may improve outcomes in the future of prostate cancer.Click Here to Manage Email Alerts