1. A phase II study of docetaxel plus lycopene in metastatic castrate resistant prostate cancer.
- Author
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Zhuang E, Uchio E, Lilly M, Zi X, and Fruehauf JP
- Subjects
- Adenocarcinoma blood, Adenocarcinoma mortality, Adenocarcinoma secondary, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, California, Disease Progression, Docetaxel adverse effects, Humans, Kallikreins blood, Lycopene adverse effects, Male, Middle Aged, Progression-Free Survival, Prostate-Specific Antigen blood, Prostatic Neoplasms, Castration-Resistant blood, Prostatic Neoplasms, Castration-Resistant mortality, Prostatic Neoplasms, Castration-Resistant pathology, Time Factors, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Docetaxel therapeutic use, Lycopene therapeutic use, Prostatic Neoplasms, Castration-Resistant drug therapy
- Abstract
We carried out a phase II study to investigate the activity of docetaxel plus lycopene in advanced castrate resistant adenocarcinoma of the prostate. Patients were chemotherapy and biological therapy naive. Docetaxel 75 mg/m
2 was given every 21 days with daily oral lycopene 30 mg. The primary endpoint was a ≥50% reduction in PSA. Secondary endpoints were median time to PSA progression, duration of response and overall survival. Thirteen patients were initiated on protocol therapy. Median age was 77 (range 55-90). Twelve patients (92%) had bone metastases. Four patients (30%) had both bone and visceral metastases. PSA response was seen in 10 patients (76.9% [95% confidence interval (CI), 46.2-94.9%]). Two patients had stable disease (SD), yielding a disease control rate of 92%. Median time to PSA progression was 8 months [95% CI, 3.5-8.7]. Median duration of response (DOR) was 7.3 months [95% CI, 4.8-13.2]. Median overall survival at 5 years was 35.1 months [95% CI 25.7-57.7]. No new safety signals were noted. No patients experienced grade 3 or above anemia. One patient (7%) experienced febrile neutropenia. A PSA response rate of 76.9% and median survival of 35.1 months compares favorably to the 45% PSA response rate and 17.4 months median survival reported for the TAX 237 trialists. While our study was limited due to small sample size, our results suggest that the combination of docetaxel and lycopene merits further study., (Copyright © 2021 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)- Published
- 2021
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