Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-8666, Japan.
Eur J Cancer. 2011 Jun;47(9):1336-42. doi: 10.1016/j.ejca.2011.03.007. Epub 2011 Mar 30.
The aim of the present phase II study was to assess the antitumour activity and safety of the combination of irinotecan and carboplatin in elderly patients with small-cell lung cancer (SCLC).
Patients with previously untreated SCLC were eligible if they had a performance status of 0-2, were 70 years or older, and had adequate organ function. Patients were treated with carboplatin at an area under the plasma concentration versus time curve of 5 min/ml on day 1 and with irinotecan at 50mg/m(2) on days 1 and 8 every 3 weeks.
Thirty patients (26 men and 4 women; median age, 76 years; age range, 70-86 years) were enrolled. Eight patients had limited disease (LD) and 22 patients had extensive disease (ED). The overall response rate was 83.3% (95% confidence interval: 65.3-94.4%). Response rates did not differ significantly between patients with LD (87.5%) and those with ED (81.8%; p=0.71). The median survival time was 14 months overall and was significantly longer in patients with LD (26 months) than in patients with ED (11 months; p=0.025). The median progression free survival time was 6 months overall and was significantly longer in patients with LD (12 months) than in patients with ED (6 months; p=0.016). Grade 3-4 toxicities included neutropenia in 83% of patients, thrombocytopenia in 47%, anaemia in 60%, infection in 23%, and diarrhoea in 20%. There were no treatment-related deaths.
This chemotherapy is safe and effective for elderly patients with SCLC.
本 II 期研究的目的是评估伊立替康联合卡铂治疗老年小细胞肺癌（SCLC）患者的抗肿瘤活性和安全性。
符合条件的患者为未经治疗的 SCLC 患者，其表现状态为 0-2 分，年龄 70 岁或以上，且器官功能良好。患者在第 1 天接受卡铂治疗，曲线下血浆浓度面积与时间的 AUC 为 5 min/ml，伊立替康在第 1 天和第 8 天给予 50mg/m2，每 3 周一次。
共纳入 30 例患者（26 例男性和 4 例女性；中位年龄为 76 岁；年龄范围为 70-86 岁）。8 例患者为局限性疾病（LD），22 例患者为广泛性疾病（ED）。总体缓解率为 83.3%（95%置信区间：65.3-94.4%）。LD 患者（87.5%）和 ED 患者（81.8%；p=0.71）的缓解率无显著差异。总生存时间的中位数为 14 个月，LD 患者（26 个月）明显长于 ED 患者（11 个月；p=0.025）。无进展生存时间的中位数为 6 个月，LD 患者（12 个月）明显长于 ED 患者（6 个月；p=0.016）。3-4 级毒性包括 83%的患者中性粒细胞减少，47%的患者血小板减少，60%的患者贫血，23%的患者感染，20%的患者腹泻。无治疗相关死亡。
该化疗方案对老年 SCLC 患者安全有效。
