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Prostate Cancer Survival Improves With Earlier Use of Docetaxel
Newly diagnosed patients with metastatic, hormone-sensitive prostate cancer gained a dramatic survival benefit when they were started on two drugs simultaneously, rather than delaying the second drug until the cancer began to worsen, according to results of a clinical trial reported in The New England Journal of Medicine (NEJM).
After a median follow-up of 28.9 months, patients who underwent six cycles of treatment with the chemotherapy drug docetaxel along with a hormone blocker had a median overall survival (OS) of 57.6 months, more than a year longer than the median 44-month OS for men who received only the hormone-blocker (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.47–0.80; P < 0.001). The median time to biochemical, symptomatic, or radiographic progression was 20.2 months in the combination group, compared with 11.7 months in the hormone-blocker-only group (HR, 0.61; 95% CI, 0.51–0.72; P < 0.001).
In the combination group, the rate of grade 3 or 4 febrile neutropenia was 6.2%, the rate of grade 3 or 4 infection with neutropenia was 2.3%, and the rate of grade 3 sensory neuropathy and of grade 3 motor neuropathy was 0.5%.
The multicenter, phase III trial, involving 790 patients (median age, 63 years), "is the first to identify a strategy that prolongs survival in men newly diagnosed with metastatic, hormone-sensitive prostate cancer," says lead author Christopher J. Sweeney, MBBS, of Dana-Farber Cancer Institute's Lank Center for Genitourinary Oncology. He said the results of the trial should change the way doctors have routinely treated such patients since the 1940s.
Sweeney reported initial results of the trial in June 2014 at the annual meeting of the American Society of Clinical Oncology (ASCO), and they were so favorable that the new regimen has been adopted by some physicians. Since then, confirmatory data from a trial called STAMPEDE were presented at the 2015 ASCO meeting, and those results, along with the new publication in the NEJM, are the final pieces "required for treatment guidelines to be updated around the globe," Sweeney said.
It has been standard practice for decades to treat this group of prostate cancer patients with hormone blockers, withholding chemotherapy until the hormone blockers become ineffective, which they do, on average, in about three years.
The new trial was designed and conducted by the ECOG-ACRIN Cancer Research Group to test Sweeney's hypothesis that adding chemotherapy to hormone treatment from the start would impair the tumor cells' ability to repair damage, delaying the development of resistance.
Sources: Dana-Farber Cancer Institute; August 5, 2015; and NEJM; August 5, 2015.