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卡铂-顺铂-依托泊苷联合化疗用于晚期非小细胞肺癌的II期研究

A phase II study of carboplatin-cisplatin-etoposide combination chemotherapy in advanced non-small-cell lung cancer.

作者信息

Makimoto T, Tsuchiya S, Nakano H, Watanabe S, Minato K, Takise A, Ezawa K, Fueki N, Naruse I, Nomoto T, Takei Y, Ishihara S, Mori M, Saitoh R

机构信息

Department of Internal Medicine, National Nishi-Gunma Hospital, Shibukawa, Gunma, Japan.

出版信息

Am J Clin Oncol. 1997 Feb;20(1):51-4. doi: 10.1097/00000421-199702000-00011.

Abstract

It is reported that the combination of cisplatin (CDDP) and carboplatin (CBDCA) is synergistic in vitro. The objective of this study was to evaluate the therapeutic effect and safety of the two platinum compounds in combination with etoposide in the treatment of non-small-cell lung cancer (NSLC). Forty patients were registered. Based on the results of a phase I study, patients were treated with CDDP (80 mg/m2 i.v. on day 1), CBDCA (280 mg/m2 i.v. on day 1), and etoposide (80 mg/m2 i.v. on days 1-3). Of the 40 patients, 30 were men and 10 women. Histology revealed adenocarcinoma(AC) (n = 20), squamous cell carcinoma(SCC) (n = 18), and large cell carcinoma(LCC) (n = 2). Staging: IIIA (n = 3); IIIB (n = 17); and IV (n = 20). A 32.5% overall response rate [13 of 40; 95% confidence interval (CI) 18-47%] was achieved. The response rates in patients with SCC and AC were 55.6 and 10.0% (p < 0.005), respectively. The median duration of response was 47.1 weeks and the overall median survival time was 57.1 weeks. Leukopenia and thrombocytopenia--World Health Organization (WHO) grade IV--occurred in nine and 11 patients, respectively. Nonhematological toxicities were mainly nausea, vomiting, and alopecia. In conclusion, further investigations of this regimen are warranted in the treatment of NSLC.

摘要

据报道,顺铂(CDDP)与卡铂(CBDCA)联合应用在体外具有协同作用。本研究的目的是评估这两种铂类化合物与依托泊苷联合治疗非小细胞肺癌(NSLC)的疗效和安全性。登记了40例患者。根据I期研究结果,患者接受顺铂(第1天静脉注射80mg/m²)、卡铂(第1天静脉注射280mg/m²)和依托泊苷(第1 - 3天静脉注射80mg/m²)治疗。40例患者中,男性30例,女性10例。组织学检查显示腺癌(AC)(n = 20)、鳞状细胞癌(SCC)(n = 18)和大细胞癌(LCC)(n = 2)。分期:IIIA期(n = 3);IIIB期(n = 17);IV期(n = 20)。总缓解率为32.5%[40例中的13例;95%置信区间(CI)18 - 47%]。SCC和AC患者的缓解率分别为55.6%和10.0%(p < 0.005)。中位缓解持续时间为47.1周,总中位生存时间为57.1周。分别有9例和11例患者出现白细胞减少和血小板减少——世界卫生组织(WHO)IV级。非血液学毒性主要为恶心、呕吐和脱发。总之,该方案在NSLC治疗中值得进一步研究。

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