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Should Docetaxel Be Added to ADT in High-Risk Prostate Cancer?

By: Lauren Harrison, MS
Posted: Thursday, April 11, 2019

Although androgen-deprivation therapy (ADT) plus docetaxel is the standard of care for hormone-naive metastatic prostate cancer, it does not significantly improve prostate-specific antigen (PSA) progression-free survival. Stéphane Oudard, MD, PhD, of Hôpital Européen Georges Pompidou, and colleagues reported their findings from their phase III randomized clinical trial in JAMA Oncology.

“Addition of docetaxel to androgen-deprivation therapy seems to be unwarranted in patients with high-risk prostate cancer without metastases in the absence of better predictors of risk for metastatic disease,” concluded the authors.

This open-label trial included 254 patients with high-risk factors but no current evidence of metastatic disease. Patients were randomly assigned to receive ADT for 1 year plus docetaxel every 3 weeks (6 cycles) or ADT alone for 1 year. PSA progression-free survival was used as the primary outcome and was defined as a greater than 50% relative increase above PSA nadir with an absolute increase of 0.2 ng/mL.

At the median follow-up of 30 months, the median PSA progression-free survival was 20.3 months with ADT plus docetaxel and 19.3 months with ADT alone (hazard ratio = 0.85, P = .31). After 10.5 years, there was no significant difference between the treatments in radiologic progression-free survival (hazard ratio=  1.03).

Common grade 3 or 4 hematologic toxic effects with ADT plus docetaxel were neutropenia (48%), febrile neutropenia (8%), and thrombocytopenia (3%). There was no significant different between the arms in terms of quality of life.

Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.



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