WHO Documents Worldwide Need for Better Drug Abuse Treatment—and Access to It

Abstract

tor, increased overall survival to 18.4 months for patients taking the drug compared with 13.6 months for those taking placebo. The randomized, double-blind, placebo-controlled, multinational phase 3 study involved 1199 patients with castration-resistant prostate cancer who had received up to 2 regimens of docetaxel-based chemotherapy. Meanwhile, a 17-year study begun in 1995 comparing intermittent androgen deprivation therapy with continuous androgen deprivation therapy came up with an answer that did not sit well with some researchers and treating physicians. In this study, 1535 patients with hormone-sensitive metastatic prostate cancer were randomized to receive intermittent or continuous androgen deprivation therapy. After a median follow-up of 9.2 years, the researchers found that intermittent therapy was not proven to be noninferior to continuous therapy and may have even increased risk for shorter survival. The findings were questioned by proponents of intermittent therapy, which has become the standard of care in many communities. Roth said he was accepting of the results. “We’re not going to redo this trial or have a confirmation trial, so we’re stuck withtheresults,”Rothsaid.“Myquestion to those in favor of intermittent therapy is, ‘Whatareyougoingto tell thenextpatient you see that you offer intermittent therapy?’Areyougoingtoarguethat this isa statistical fluke?Howcanyoudefend that? The data are the data.”