Smith John W, McIntyre Kristi J, Acevedo Patrick V, Encarnacion Carlos A, Tedesco Karen L, Wang Yunfei, Asmar Lina, O'Shaughnessy Joyce A
US Oncology Research, Inc., The Woodlands, TX, USA.
Breast Cancer Res Treat. 2009 Nov;118(2):361-7. doi: 10.1007/s10549-009-0410-5. Epub 2009 May 21.
Cisplatin and carboplatin have antitumor activity in breast cancer. Satraplatin, an orally bioavailable platinum analog, offers a potential alternative to intravenous chemotherapy. We conducted a multicenter phase II study of this agent as first- or second-line treatment of metastatic breast cancer. Satraplatin 80 mg/m(2) was taken PO Days 1-5 q 21 days in cycles 1 and 2, and if tolerated, increased to 100 mg/m(2) for subsequent cycles. Restaging studies to assess response were performed after every 2 cycles. Between November 2005 and March 2006, 40 patients were enrolled. Baseline characteristics: 48% prior adjuvant chemotherapy, 60% prior chemotherapy for MBC; median age, 62 years (ranges 43-83), 58% ER+/PR+, 23% ER+/PR-, 18% ER-/PR-/HER2-, and 5% HER2+. In 31 patients with measurable disease, there were two partial responses (PR; 6%; 95% CI 0, 15.2); and four patients (13%) had SD > or =6 months for a clinical benefit rate of 19%. Among the subanalysis of seven triple-negative patients with measurable disease, there were 2 SD and 2 PD. Median survival was 15 months and median progression-free survival was 2.7 months. The most common grade 3-4 toxicities were neutropenia (28%) and thrombocytopenia (25%). AEs leading to treatment discontinuation were nausea (n = 3), thrombocytopenia (n = 3), fever (n = 2), and vomiting (n = 2). This phase II study demonstrates oral satraplatin has limited activity as a single agent for MBC. Satraplatin, at a lower dose used in this study, could be combined with other chemotherapy agents in future trials in breast cancer.
顺铂和卡铂对乳腺癌具有抗肿瘤活性。沙铂是一种口服生物可利用的铂类似物，为静脉化疗提供了一种潜在的替代方案。我们开展了一项多中心II期研究，将该药物作为转移性乳腺癌的一线或二线治疗。在第1和第2周期中，沙铂80mg/m²于第1 - 5天口服，每21天为一个周期，若耐受，则后续周期剂量增至100mg/m²。每2个周期后进行重新分期研究以评估疗效。2005年11月至2006年3月，共入组40例患者。基线特征：48%曾接受辅助化疗，60%曾接受MBC化疗；中位年龄62岁（范围43 - 83岁），58% ER+/PR+，23% ER+/PR-，18% ER-/PR-/HER2-，5% HER2+。在31例可测量病灶的患者中，有2例部分缓解（PR；6%；95% CI 0，15.2）；4例患者（13%）疾病稳定≥6个月，临床获益率为19%。在对7例可测量病灶的三阴性患者的亚分析中，有2例疾病稳定和2例疾病进展。中位生存期为15个月，中位无进展生存期为2.7个月。最常见的3 - 4级毒性反应为中性粒细胞减少（28%）和血小板减少（25%）。导致治疗中断的不良事件有恶心（n = 3）、血小板减少（n = 3）、发热（n = 2）和呕吐（n = 2）。这项II期研究表明，口服沙铂作为MBC的单一药物活性有限。在本研究中使用的较低剂量的沙铂，在未来乳腺癌试验中可与其他化疗药物联合使用。
