伊立替康作为晚期非小细胞肺癌三线或四线治疗的II期研究：NJLCG0703

Phase II study of irinotecan as a third- or fourth-line treatment for advanced non-small cell lung cancer: NJLCG0703.

作者信息

Matsubara Nobumichi, Maemondo Makoto, Inoue Akira, Ishimoto Osamu, Watanabe Kana, Sakakibara Tomohiro, Fukuhara Tatsuro, Morikawa Naoto, Tanaka Masashi, Sugawara Shunichi, Nukiwa Toshihiro

机构信息

Department of Respiratory Medicine, Miyagi Cancer Center, 47-1 Nodayama, Medeshima-shiote, Natori, 981-1293, Japan.

出版信息

Respir Investig. 2013 Mar;51(1):28-34. doi: 10.1016/j.resinv.2012.09.004. Epub 2012 Nov 13.

DOI:10.1016/j.resinv.2012.09.004

PMID:23561256

Abstract

BACKGROUND

We aimed to evaluate the efficacy and safety of irinotecan monotherapy as a third- or fourth-line treatment for advanced non-small cell lung cancer (NSCLC) patients.

METHODS

Patients with advanced NSCLC refractory to 2 or more previous regimens were treated with 80 mg/m2 irinotecan on days 1, 8, and 15, every 4 weeks. The primary endpoint was the overall response rate (ORR), whereas secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profiles.

RESULTS

From December 2007 to April 2009, 32 patients (median age, 60 years) were enrolled. Most of the patients (75.0%) were male, and 18.8% had a performance status of 2. Six partial responses to irinotecan monotherapy were observed (ORR, 18.8%: 95% confidence interval, 5.3%-32.3%). The disease control rate (DCR) was 78.1%, median PFS was 4.0 months, and median survival time (MST) was 10.4 months. Grade 3-4 neutropenia was observed in 22% of patients, but other toxic effects were moderate. No cases of grade 3-4 diarrhea or treatment-related death were noted. Of the 15 patients for whom progressive disease represented the best response to previous treatment regimens, 2 exhibited a partial response and 9 showed stable disease after irinotecan monotherapy, with a DCR of 73.3%, median PFS of 4.4 months, and MST of 8.2 months.

CONCLUSIONS

Irinotecan monotherapy is effective for advanced NSCLC patients who have previously failed 2 or more treatment regimens.

摘要

背景

我们旨在评估伊立替康单药治疗作为晚期非小细胞肺癌（NSCLC）患者三线或四线治疗的疗效和安全性。

方法

对先前接受过2种或更多治疗方案后难治的晚期NSCLC患者，每4周在第1、8和15天给予80mg/m²伊立替康治疗。主要终点为总缓解率（ORR），次要终点包括无进展生存期（PFS）、总生存期（OS）和毒性反应。

结果

2007年12月至2009年4月，共纳入32例患者（中位年龄60岁）。大多数患者（75.0%）为男性，18.8%的患者体能状态为2。观察到6例对伊立替康单药治疗有部分缓解（ORR为18.8%：95%置信区间为5.3%-32.3%）。疾病控制率（DCR）为78.1%，中位PFS为4.0个月，中位生存时间（MST）为10.4个月。22%的患者出现3-4级中性粒细胞减少，但其他毒性反应为中度。未观察到3-4级腹泻或治疗相关死亡病例。在15例对先前治疗方案最佳反应为疾病进展的患者中，2例出现部分缓解，9例在伊立替康单药治疗后病情稳定，DCR为73.3%，中位PFS为4.4个月，MST为8.2个月。