Department of Medicine, Division of Hematology/Oncology, Chao Family Comprehensive Cancer Center, University of California Irvine, USA.
Department of Urology, University of California Irvine, USA.
Biomed Pharmacother. 2021 Nov;143:112226. doi: 10.1016/j.biopha.2021.112226. Epub 2021 Sep 24.
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 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.
我们进行了一项 II 期研究，旨在探讨多西他赛联合番茄红素在晚期去势抵抗性前列腺腺癌中的活性。患者未接受过化疗和生物治疗。多西他赛 75mg/m2 每 21 天给药一次，同时每日口服番茄红素 30mg。主要终点为 PSA 降低≥50%。次要终点为 PSA 进展的中位时间、缓解持续时间和总生存期。13 名患者开始接受方案治疗。中位年龄为 77 岁（55-90 岁）。12 名患者（92%）有骨转移。4 名患者（30%）有骨转移和内脏转移。10 名患者（76.9%[95%可信区间（CI），46.2-94.9%]）出现 PSA 反应。2 名患者疾病稳定（SD），疾病控制率为 92%。PSA 进展的中位时间为 8 个月[95%CI，3.5-8.7]。中位缓解持续时间（DOR）为 7.3 个月[95%CI，4.8-13.2]。5 年总生存率为 35.1 个月[95%CI 25.7-57.7]。未发现新的安全信号。无 3 级或以上贫血患者。1 名患者（7%）发生发热性中性粒细胞减少症。PSA 反应率为 76.9%，中位生存时间为 35.1 个月，与 TAX 237 试验报告的 45%PSA 反应率和 17.4 个月中位生存时间相比具有优势。虽然我们的研究由于样本量小而受到限制，但我们的结果表明，多西他赛联合番茄红素值得进一步研究。
