贝伐珠单抗和司他膦酸盐在多西紫杉醇预处理的转移性去势抵抗性前列腺癌中的 II 期临床试验。
Phase II trial of bevacizumab and satraplatin in docetaxel-pretreated metastatic castrate-resistant prostate cancer.
机构信息
Department of Oncology, Department of Medicine, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI.
Department of Oncology, Department of Medicine, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI.
出版信息
Urol Oncol. 2014 Jan;32(1):31.e25-33. doi: 10.1016/j.urolonc.2012.11.017. Epub 2013 Feb 21.
BACKGROUND
Satraplatin is an oral platinum compound that has demonstrated efficacy and tolerability in prostate cancer. Preclinical synergy between bevacizumab and platinum has been noted.
METHODS
Docetaxel-pretreated metastatic castrate-resistant prostate cancer patients with disease progression were eligible. Satraplatin 80 mg/m(2) orally on days 1 to 5, prednisone 5mg twice daily, and bevacizumab 10mg/kg on day 1, and 15 mg/kg on day 15 were administered in 35-day cycles.
RESULTS
Thirty one patients were enrolled. Grade 3 or 4 toxicities were pulmonary embolism in 2 patients and thrombocytopenia in 1 patient. 31% of the patients had a ≥ 30% decline in prostate-specific antigen. Median time to progression was 7.0 months (90% confidence interval [CI] 4.7-8.5mo) and median overall survival was 11.2 months (90% CI 9.1-16.4 mo). Polymorphism in the excision repair cross-complementation-1 (ERCC-1) gene was associated with time to progression (hazard ratio = 1.91). A circulating tumor cell count ≥ 5 was moderately prognostic of overall survival (hazard ratio = 1.49) as compared with CTC <5.
CONCLUSIONS
The combination was tolerable, and revealed promising efficacy in metastatic castrate-resistant prostate cancer. ERCC1 genotype maybe predictive of clinical benefit with platinum-based therapy in metastatic prostate cancer.
背景
Satraplatin 是一种口服铂化合物，已在前列腺癌中显示出疗效和耐受性。已注意到贝伐单抗和铂之间的临床前协同作用。
方法
符合条件的是接受多西他赛预处理的转移性去势抵抗性前列腺癌患者，疾病进展。Satraplatin 80mg/m² 口服，每天 1 至 5 天，泼尼松 5mg，每日两次，贝伐单抗 10mg/kg 于第 1 天，15mg/kg 于第 15 天，每 35 天为一个周期。
结果
共纳入 31 例患者。2 例患者发生 3 级或 4 级肺栓塞，1 例患者发生血小板减少症。31%的患者前列腺特异性抗原下降≥30%。中位无进展生存期为 7.0 个月（90%置信区间 [CI] 4.7-8.5mo），中位总生存期为 11.2 个月（90%CI 9.1-16.4 mo）。切除修复交叉互补基因 1（ERCC-1）基因的多态性与无进展时间相关（风险比=1.91）。循环肿瘤细胞计数≥5 与 CTC<5 相比，对总生存期有中度预后意义（风险比=1.49）。
结论
该联合方案耐受良好，在转移性去势抵抗性前列腺癌中显示出有希望的疗效。ERCC1 基因型可能是预测转移性前列腺癌铂类治疗临床获益的指标。
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