Six cycles of docetaxel at the beginning of androgen deprivation therapy (ADT) for treatment-naïve men with metastatic, hormone-sensitive prostate cancer resulted in significantly longer overall survival than with ADT alone, a new study published online ahead of print in The New England Journal of Medicine has shown.1
“In the current environment, [docetaxel] is typically given late in the course of patients after they have failed other types of hormone therapy,” study author David F. Jarrard, MD, professor of urologic surgery at the University of Wisconsin School of Medicine and Public Health, in Madison, WI, said in an interview with Cancer Therapy Advisor.
The CHAARTED study showed that after a median follow-up of 28.9 months, the median overall survival was 57.6 months with ADT plus docetaxel compared with 44.0 months with ADT alone (HR for death = 0.61; 95% CI: 0.47, 0.80; P<0.001).1
In addition, the median time to biochemical, symptomatic, or radiographic progression was 8.5 months longer with the combination than ADT alone (HR = 0.61; 95% CI: 0.51, 0.72; P<0.001).
The rate of a prostate-specific antigen (PSA) level less than 0.2 ng/mL at 12 months was 27.7% and 16.8%, respectively (P<0.001).
For the study, researchers enrolled 790 patients with a median age of 63 years with metastatic, hormone-sensitive prostate cancer. Participants were randomly assigned to receive ADT plus docetaxel 75 mg/m2 intravenously every 3 weeks for six cycles or ADT alone.
“No advances [had] been made in hormone-sensitive metastatic disease since the 1940s, and knowing docetaxel worked in late-stage, castration-resistant disease, it was logical to see if it had more of an effect in [the early] stage setting,” principal investigator Christopher J. Sweeney, MBBS, associate professor of medicine at Harvard Medical School and Senior Physician at Dana-Farber Cancer Institute in Boston, MA, told Cancer Therapy Advisor.
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In regard to safety, 6.2% and 2.3% of patients in the combination group experienced grade 3 or 4 febrile neutropenia and grade 3 or 4 infection with neutropenia, respectively. The rate of grade 3 sensory neuropathy and of grade 3 motor neuropathy was 0.5% in those who received docetaxel.