medwireNews: Continuing enzalutamide treatment in combination with docetaxel reduces the risk for progression versus placebo plus docetaxel in men with metastatic castration-resistant prostate cancer (mCRPC) that progressed during enzalutamide monotherapy, PRESIDE study data show.
The findings were presented by Axel Merseburger (Universitätsklinikum Schleswig-Holstein, Lübeck, Germany) at the 2022 ASCO Genitourinary Cancers Symposium in San Francisco, California, USA.
Axel Merseburger discusses the results of the PRESIDE trial of enzalutamide rechallenge in metastatic castration-resistant prostate cancer in the context of the current treatment landscape, and outlines unanswered questions (4:35).
He reported that, during the first period of the PRESIDE study, 687 chemotherapy-naïve men with mCRPC that had progressed on androgen deprivation therapy received enzalutamide 160 mg/day.
Those with confirmed disease progression (n=271) after an initial prostate-specific antigen (PSA) or radiographic response in the first 13 weeks then moved to the second period of the study during which they were randomly assigned to continue with enzalutamide 160 mg/day (n=136) or to receive placebo (n=135), each given in combination with docetaxel 75 mg/m2 every 3 weeks and prednisolone 10 mg/day.
During period 2, the researchers found that the risk for disease progression was a significant 28% lower among the people who continued with enzalutamide relative to those given placebo, with median progression-free survival of 9.5 and 8.3 months, respectively.
In addition, men who received enzalutamide during period 2 had a significantly longer median time to PSA progression than those who received placebo, at 8.4 versus 6.2 months, which corresponded to a significant 42% lower risk for PSA progression with enzalutamide.
Enzalutamide use also resulted in a mean 37.1% decrease in PSA levels during the first 13 weeks of period 2, which was significantly different from the 9.1% mean increase observed in the placebo group.
The overall response rate was numerically higher with enzalutamide, at 31.6%, than with placebo, at 25.9%.
Merseburger said that when enzalutamide was combined with docetaxel it “retained an acceptable safety profile consistent with the known individual safety profiles of these drugs.”
Treatment-related adverse events (TRAEs) occurred in 46.3% of individuals in the enzalutamide arm and 41.5% of those in the placebo arm, with serious TRAEs recorded in a respective 5.1% and 7.4%.
Merseburger concluded: “These data suggest that continued treatment with enzalutamide plus docetaxel offers clinical benefit and could be a future treatment option for some patients who progress on enzalutamide alone.”
Discussant Elisabeth Heath (Wayne State University School of Medicine, Detroit, Michigan, USA) congratulated Merseburger and colleagues on the study and agreed that the regimen they tested is a treatment option for men who have progressed on enzalutamide monotherapy, but cautioned that it is not a new standard of care.
She said that “knowing your patient matters,” and in this case the combination therapy can be considered for men with an initial response to enzalutamide who ultimately progressed but show ongoing clinical benefit and are fit enough for combination treatment.
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