Phase II study of a gemcitabine and cisplatin combination regimen in taxane resistant metastatic breast cancer
Phase II study of a gemcitabine and cisplatin combination regimen in taxane resistant metastatic breast cancer
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DOI：
10.1007/s00280-006-0266-x
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发表时间：
2007-02-01
影响因子：
3
通讯作者：
Koo, Bum Hwan
中科院分区：
文献类型：
--
作者：
Seo, Jae Hong;Oh, Sang Cheul;Koo, Bum Hwan
目的：观察吉西他滨联合顺铂治疗紫杉烷类耐药转移性乳腺癌的疗效和安全性。患者及方法：33例紫杉烷耐药转移性乳腺癌患者接受吉西他滨1，250 mg/m2静脉输注30 min，第1天和第8天，顺铂75 mg/m2静脉输注1 h，第1天，21天为1个周期。结果：在30例可评价患者中，有9例（30%）部分缓解，无完全缓解，总体客观缓解率为30%。所有研究受试者的中位至进展时间和中位生存期分别为7个月（95% CI 5.1-8.9个月）和15个月（95% CI 10.5-19.5个月）。毒性反应包括3级和4级白细胞减少10例（30%），血小板减少6例（18%），贫血2例（6%）和口腔粘膜炎2例（6%）。未观察到3级或4级周围神经病变、肾功能不全、肝功能不全或恶心/呕吐，未发生治疗相关死亡。结论：所述吉西他滨加顺铂联合治疗被认为是紫杉烷耐药转移性乳腺癌患者的有效和可耐受的挽救方案。
Purpose: To determine the safety and efficacy of gemcitabine and cisplatin in patients with taxane resistant metastatic breast cancer. Patients and methods: Thirty-three taxane resistant metastatic breast cancer patients were treated with gemcitabine 1,250 mg/m(2) IV infusion over 30 min on days 1 and 8, and with cisplatin 75 mg/m(2) by IV infusion over 1h on day 1 in 21 day cycles. Results: Of the 30 evaluable patients, there were 9 (30%) partial responses and no complete response, an overall objective response rate of 30%. Median time to progression and median survival duration for all study subjects were 7 (95% CI 5.1-8.9 months) and 15 months (95% CI 10.5-19.5 months), respectively. Toxicities included grade 3 and 4 leucopenia in 10 ( 30%), thrombocytopenia in 6 (18%), anemia in 2 (6%) and oral mucositis in 2 (6%). No grade 3 or 4 peripheral neuropathy, renal dysfunction, hepatic dysfunction, or nausea/vomiting was observed, and no treatment-related deaths occurred. Conclusion: The described gemcitabine plus cisplatin combination was found to be an active and tolerable salvage regimen in patients with taxane resistant metastatic breast cancer.