A prospective phase-II trial of biweekly docetaxel plus androgen deprivation therapy in patients with previously-untreated metastatic castration-naïve prostate cancer

• Published in: BMC cancer 2021-11, Vol.21 (1), p.1281-7, Article 1281
• Main Authors: Byeon, Seonggyu, Kim, Hongsik, Jeon, Hwang Gyun, Seo, Seong Il, Jeon, Seong Soo, Lee, Hyun Moo, Lee, Soon Il, Park, Se Hoon
• Format: Article
• Language: English
• Subjects: Adverse events; Aged; Aged, 80 and over; Androgen Antagonists - administration & dosage; Androgen Antagonists - adverse effects; Androgen suppression therapy; Androgens; Anemia - chemically induced; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Castration; Chemotherapy, Combination; Diarrhea; Diarrhea - chemically induced; Disease-Free Survival; Docetaxel; Docetaxel - administration & dosage; Docetaxel - adverse effects; Drug Administration Schedule; Drug therapy; Fatigue - chemically induced; Follow-Up Studies; Hematology; Humans; Hypotheses; Male; Metastases; Metastasis; Methods; Middle Aged; Mucositis; Nail Diseases - chemically induced; Neutropenia; Neutropenia - chemically induced; Patients; Pneumonia - chemically induced; Pneumonitis; Prospective Studies; Prostate cancer; Prostate-specific antigen; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms, Castration-Resistant; Stomatitis - chemically induced; Survival; Testing
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-021-09018-6

The aim of this prospective phase II study was to evaluate the efficacy and safety of biweekly docetaxel plus androgen-deprivation therapy (ADT) in patients with metastatic castration-naïve prostate cancer (mCNPC). Patients with histologically-proven, previously-untreated mCNPC received ADT plus docetaxel, 40 mg/m . Docetaxel was repeated every 2 weeks, up to 12 cycles. Endpoints included castration-resistant prostate cancer (CRPC)-free survival, prostate-specific antigen (PSA) response, and safety. A total of 42 patients were registered and analyzed for final outcomes. Of the 42 patients, 36 (86%) completed the 12 planned cycles of docetaxel plus ADT. During a median follow up of 25 months, all but two patients (95%) achieved a PSA response with a nadir PSA level of 0.42 ng/ml (range 0.01-1280.87). The median CRPC-free survival was 26.4 months (95% confidence interval [CI] 20.9-32.0) with a one-year CRPC-free rate of 79% (33 patients, 95% CI 66-91). Multivariable analysis revealed that the performance status of the Eastern Cooperative Oncology Group 0 was independently associated with longer CRPC-free survival (hazard ratio [HR] 0.27, 95% CI 0.07-0.99). The most common adverse events of any grade were anemia (95%), followed by nail changes (33%), fatigue (29%), and oral mucositis (26%). Severe (grade 3 or higher) adverse events were infrequent: pneumonitis (n = 2), diarrhea (n = 1), and neutropenia (n = 1). Our results suggest that biweekly docetaxel plus ADT is feasible, and clinical efficacy does not seem to be compromised compared to a standard triweekly docetaxel 75 mg/m plus ADT regimen.