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

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). | Byeon et al. BMC Cancer 2021 21 1281 https s12885-021-09018-6 RESEARCH Open Access A prospective phase-II trial of biweekly docetaxel plus androgen deprivation therapy in patients with previously-untreated metastatic castration-naïve prostate cancer Seonggyu Byeon1 Hongsik Kim2 Hwang Gyun Jeon3 Seong Il Seo3 Seong Soo Jeon3 Hyun Moo Lee3 Soon Il Lee4 and Se Hoon Park2 Abstract Introduction The aim of this prospective phase II study was to evaluate the efficacy and safety of biweekly doc- etaxel plus androgen-deprivation therapy ADT in patients with metastatic castration-naïve prostate cancer mCNPC . Patients and methods Patients with histologically-proven previously-untreated mCNPC received ADT plus doc- etaxel 40 mg m2. 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. Results A total of 42 patients were registered and analyzed for final outcomes. Of the 42 patients 36 86 com- pleted 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 ng ml range . The median CRPC-free survival was months 95 confidence interval CI 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 95 CI . 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 . Conclusion 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 m2 plus

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