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伊立替康联合顺铂与依托泊苷联合顺铂治疗小细胞肺癌的随机临床试验

Irinotecan plus cisplatin compared with etoposide plus cisplatin for small cell lung cancer: a randomized clinical trial.

作者信息

Pan Deng, Hou Mei, Li Hui, Yu Ping, Liu Jianwei

机构信息

Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P.R.China.

出版信息

Zhongguo Fei Ai Za Zhi. 2006 Oct 20;9(5):443-6. doi: 10.3779/j.issn.1009-3419.2006.05.11.

Abstract

BACKGROUND

Etoposide plus cisplatin (EP) is a standard combination chemotherapy regimen for small cell lung cancer (SCLC). The objective of this randomized trial is to compare the efficacy and toxicity of combined chemotherapy regimen of irinotecan plus cisplatin (IP) with the EP regimen in the treatment of SCLC.

METHODS

A randomized clinical trial was conducted in which the IP regimen was compared with EP regimen in the treatment of patients with SCLC. A total of 61 patients were randomly divided into IP group (n=30) and EP group (n=31). All patients were given more than two chemotherapy cycles.

RESULTS

(1)The overall response rate was 66.7% in IP group and 61.3% in EP group respectively. The complete response was 23.3% in IP group and 16.1% in EP group. There was no significant difference in the response rate between the two groups (P > 0.05). (2)Severe or life-threatening myelosuppressions such as leucopenia, neutropenia and thrombocytopenia were more frequent in EP group than those in IP group (P < 0.01), and severe diarrhea was more frequent in IP group than that in EP group, and there was significant statistical difference (P=0.008).

CONCLUSIONS

IP regimen is an effective regimen for SCLC. Compared with EP regimen, IP regimen has less hematological toxicities but higher diarrhea incidence. The diarrhea of irinotecan can be controlled by appropriate treatment.

摘要

背景

依托泊苷联合顺铂(EP)是小细胞肺癌(SCLC)的标准联合化疗方案。本随机试验的目的是比较伊立替康联合顺铂(IP)方案与EP方案在治疗SCLC中的疗效和毒性。

方法

进行了一项随机临床试验,比较IP方案与EP方案治疗SCLC患者的疗效。共61例患者被随机分为IP组(n = 30)和EP组(n = 31)。所有患者均接受了两个以上的化疗周期。

结果

(1)IP组和EP组的总缓解率分别为66.7%和61.3%。IP组的完全缓解率为23.3%,EP组为16.1%。两组缓解率差异无统计学意义(P>0.05)。(2)EP组白细胞减少、中性粒细胞减少和血小板减少等严重或危及生命的骨髓抑制比IP组更常见(P<0.01),IP组严重腹泻比EP组更常见,差异有统计学意义(P = 0.008)。

结论

IP方案是治疗SCLC的有效方案。与EP方案相比,IP方案血液学毒性较小,但腹泻发生率较高。伊立替康所致腹泻可通过适当治疗得到控制。

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