Background: Results from randomized phase III trials have shown that thrice-weekly docetaxel added to androgendeprivation\ntherapy (ADT) has a significant impact on the survival of patients with metastatic castration-naïve prostate\ncancer (mCNPC) and established early chemotherapy as part of the standard of care for high-risk disease. Controversy\nremains, however, because some patients experience critical toxicities related to docetaxel. The purpose of the current\nstudy was to evaluate the feasibility and adverse events of biweekly-administered docetaxel in patients with previouslyuntreated,\nhigh-risk mCNPC.\nMethods: The study included 35 consecutive patients with high-risk mCNPC who received ADT plus docetaxel 40 mg/\nM^2. Oral prednisone 5 mg twice daily was also given. Treatment was repeated every two weeks for up to 12 cycles or\nuntil disease progression or unacceptable toxicity occurred. High-risk was defined as bone metastases beyond axial\nskeleton and/or visceral disease.\nResults: The included patientsâ?? median age was 68 years (range: 31-86 years) and 17 (49%) had visceral metastases.\nBiweekly docetaxel was generally well-tolerated; the most commonly observed adverse events, considering those of all\ngrades, included alopecia (74%), nail changes (42%), and constipation (31%). Hematologic adverse events were\ninfrequent, and no patient received hematopoietic growth factors. One patient died after the fourth cycle due\nto respiratory failure, which occurred as a complication of pneumonia. Among the 35 patients, 28 completed\nthe planned 12 cycles of biweekly docetaxel. Prostate-specific antigen response (> 50% decrease from baseline)\nwas recorded in 33 patients (94%), and the radiologic response rate was 49%. Median progression-free survival was\n13.6 months (95% confidence interval: 6.7-20.4).\nConclusion: ADT plus biweekly-administered docetaxel appeared to be tolerated and effective in patients with\nhigh-risk mCNPC.
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