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吉西他滨和顺铂联合方案用于紫杉烷耐药转移性乳腺癌的II期研究

Phase II study of a gemcitabine and cisplatin combination regimen in taxane resistant metastatic breast cancer.

作者信息

Seo Jae Hong, Oh Sang Cheul, Choi Cheul Won, Kim Byung Soo, Shin Sang Won, Kim Yeul Hong, Kim Jun Suk, Kim Ae-Ree, Lee Jae-Bok, Koo Bum Hwan

机构信息

Department of Internal Medicine, Division of Hematology/Oncology, College of Medicine, Korea University Guro Hospital, 97 Gurodong-gil, Guro-ku, Seoul, Korea, 152-703.

出版信息

Cancer Chemother Pharmacol. 2007 Feb;59(2):269-74. doi: 10.1007/s00280-006-0266-x. Epub 2006 Jun 9.

DOI:10.1007/s00280-006-0266-x
PMID:16763791
Abstract

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/m2 IV infusion over 30 min on days 1 and 8, and with cisplatin 75 mg/m2 by IV infusion over 1 h 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.

摘要

目的

确定吉西他滨和顺铂用于紫杉烷耐药转移性乳腺癌患者的安全性和有效性。

患者与方法

33例紫杉烷耐药转移性乳腺癌患者接受治疗,在第1天和第8天,静脉输注吉西他滨1250mg/m²,持续30分钟;在第1天静脉输注顺铂75mg/m²,持续1小时,每21天为一个周期。

结果

30例可评估患者中,有9例(30%)部分缓解,无完全缓解,总客观缓解率为30%。所有研究对象的中位疾病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:粒细胞减少3/4级10例(30%),血小板减少6例(18%),贫血2例(6%),口腔黏膜炎2例(6%)。未观察到3/4级周围神经病变、肾功能不全、肝功能不全或恶心/呕吐,且未发生与治疗相关的死亡。

结论

在紫杉烷耐药转移性乳腺癌患者中,所描述的吉西他滨联合顺铂方案是一种有效的且耐受性良好的挽救方案。

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