Phase II trial of cisplatin plus prednisone in docetaxel-refractory castration-resistant prostate cancer patients
Phase II trial of cisplatin plus prednisone in docetaxel-refractory castration-resistant prostate cancer patients
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DOI：
10.1007/s00280-011-1594-z
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发表时间：
2011-06-01
影响因子：
3
通讯作者：
Lorenzo, Giuseppe Di
中科院分区：
文献类型：
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作者：
Buonerba, Carlo;Federico, Piera;Lorenzo, Giuseppe Di
背景 多西他赛是去势抵抗性前列腺癌 (CRPC) 的一线治疗方法。 CRPC患者的后续治疗方案需要新的治疗方案。 方法 2007年4月至2010年1月，在那不勒斯费德里科二世大学分子和临床肿瘤学和内分泌科入组接受多西紫杉醇预处理的进展性CRPC患者。纳入的患者每3周接受75 mg/m(2)剂量的顺铂治疗，每日10 mg泼尼松。反应和进展的测量是根据前列腺癌工作组 (PCWG1) 标准定义的。根据美国国家癌症研究所通用毒性标准 3.0 版对毒性进行分级。结果 招募了 25 名患者。中位年龄为 65 岁（四分位数范围 55-74 岁）。所有患者均可评估 PSA 反应和毒性，其中 13 名患者 (52%) 可评估可测量疾病。总共进行了170个周期的顺铂化疗。中位剂量强度相当于可输送的最大剂量强度的 96%（范围 83.8-98.3%）。 3 名患者 (12%) 出现 3-4 级神经病变，10 名患者 (40%) 出现 3-4 级中性粒细胞减少症。 5 名患者 (20%) 的 PSA 下降超过 50%，13 名患有可测量疾病的患者中有 3 名出现部分缓解。中位无进展生存期为 5.6 个月（24 周；范围 15-24）。中位生存期为 55 周（范围 46-64；见图 1）。 结论 顺铂加泼尼松似乎代表了多西紫杉醇难治性 CRPC 的积极治疗方案，且毒性特征可接受。有必要在这种情况下进行进一步的调查，以证实这些早期令人鼓舞的发现。
Background Docetaxel represents the first-line treatment for castration-resistant prostate cancer (CRPC). New therapeutic options are needed for subsequent lines of therapy in CRPC patients.Methods Patients with progressive CRPC, pretreated with docetaxel, were enrolled at the Department of Molecular and Clinical Oncology and Endocrinology of University 'Federico II of Naples' from April 2007 to January 2010. Accrued patients received cisplatin at the dose of 75 mg/m(2) every 3 weeks with daily 10 mg prednisone. Measures of response and progression were defined according to the Prostate Cancer Working Group (PCWG1) criteria. Toxicity was graded according to the Common Toxicity Criteria of the National Cancer Institute, version 3.0.Results Twenty-five patients were recruited. Median age was 65 years (interquartile range 55-74 years). All patients were evaluable for PSA response and toxicity and thirteen patients (52%) were evaluable for measurable disease. A total of 170 cycles of cisplatin chemotherapy were administered. Median dose intensity corresponded to 96% (range 83.8-98.3%) of the maximum dose intensity that could be delivered. Three patients (12%) presented grade 3-4 neuropathy and ten (40%) presented grade 3-4 neutropenia. Five patients (20%) showed a greater than 50% PSA decline, and three of thirteen patients with measurable disease presented a partial response. Median progression-free survival was 5.6 months (24 weeks; range 15-24). Median survival was 55 weeks (range 46-64; see Fig. 1).Conclusions Cisplatin plus prednisone appears to represent an active regimen in docetaxel-refractory CRPC with an acceptable toxicity profile. Further investigations in this setting are warranted to confirm these early encouraging findings.