Phase II Trial of Amrubicin for Second-Line Treatment of Advanced Non-small Cell Lung Cancer Results of the West Japan Thoracic Oncology Group Trial (WJTOG0401)
Phase II Trial of Amrubicin for Second-Line Treatment of Advanced Non-small Cell Lung Cancer Results of the West Japan Thoracic Oncology Group Trial (WJTOG0401)
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DOI：
10.1097/jto.0b013e3181c07c6c
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发表时间：
2010-01-01
影响因子：
20.4
通讯作者：
Nakagawa, Kazuhiko
中科院分区：
文献类型：
--
作者：
Kaneda, Hiroyasu;Okamoto, Isamu;Nakagawa, Kazuhiko
背景：氨柔比星是一种合成蒽环类药物，是一种有效的拓扑异构酶II抑制剂。我们已经进行了一个阶段，它的临床试验，以评估氨柔比星的疗效和安全性与以前治疗的非小细胞肺癌（NSCLC）的患者。方法：晚期NSCLC谁经历了疾病复发后，一个铂为基础的化疗方案有资格在这项研究中招募。氨柔比星以40 mg/m2的剂量静脉注射给药，每3周连续3天。结果：61例入选患者共接受了192个治疗周期（中位数，2;范围，1-15）。反应如下：完全反应，0;部分反应，7（11.5%）;稳定疾病，20（32.8%）;和。疾病进展34例（55.7%）。中位无进展生存期为1.8个月，而中位总生存期为8.5个月，1年生存率为32%。3级或4级血液学毒性包括中性粒细胞减少（82.0%）、白细胞减少（73.8%）、血小板减少（24.6%）和贫血（27.9%）。18例患者（29.5%）发生发热性中性粒细胞减少。观察到1例因感染导致的治疗相关死亡。nonhematologictoxicswere mild.Conclusions：氨柔比星是一种可能的替代二线治疗晚期NSCLC，虽然相关的血液学毒性是显着的，特别是与发热性中性粒细胞减少症。
Background: Amrubicin is a synthetic anthracycline drug that is a potent inhibitor of topoisomerase II. We have performed a phase It trial to evaluate the efficacy and safety of amrubicin for patients with previously treated non-small cell lung cancer (NSCLC).Methods: Patients with advanced NSCLC who experienced disease recurrence after one platinum-based chemotherapy regimen were eligible for enrollment in the study. Amrubicin was administered by intravenous injection at a dose of 40 mg/m(2) on 3 consecutive days every 3 weeks.Results: Sixty-one enrolled patients received a total of 192 treatment cycles (median, 2; range, 1-15). Response was as follows: complete response, 0; partial response, seven (11.5%); stable discase, 20 (32.8%); and. progressive disease, 34 (55.7%). Median progression-free survival was 1.8 months, whereas median overall survival was 8.5 months, and the 1-year survival rate was 32%. Hematologic toxicities of grade 3 or 4 included neutropenia (82.0%), leukopenia (73.8%), thrombocytopenia (24.6%), and anemia (27.9%). Febrile neutropenia occurred in 18 patients (29.5%). One treatment-related death due to infection was observed. Nonhematologic toxicities were mild.Conclusions: Amrubicin is a possible alternative for second-line treatment of advanced NSCLC, although a relevant hematological toxicity is significant, especially with a febrile neutropenia.