Department of Respiratory Medicine, NHO Shikoku Cancer Center, Matsuyama, Japan.
Acta Oncol. 2012 Jul;51(6):768-73. doi: 10.3109/0284186X.2011.648342. Epub 2012 Jan 27.
The survival advantage achieved by existing anti-cancer agents as second-line therapy for relapsed non-small cell lung cancer (NSCLC) is modest and further improvement of treatment outcome is desired. Combination chemotherapy with irinotecan and amrubicin for advanced NSCLC has not been fully evaluated.
The primary endpoint of this phase II clinical trial was objective response. Patients with NSCLC who had been treated previously with one or two chemotherapy agents were enrolled. Irinotecan and amrubicin were both administered on Days 1 and 8 of a 21-day cycle, at doses of 100 mg/m(2) and 40 mg/m(2), respectively.
Between 2004 and 2006, 31 patients received a total of 101 courses; the median number of courses administered was three (range, one to six). Objective response was obtained in nine of the 31 patients (29.0% response rate; 95% confidence interval (CI), 12.1-46.0%). With a median follow-up time of 43.9 months, median survival time and the median progression-free survival time were 14.2 and 4.0 months, respectively. Myelosuppression was the most frequently observed adverse event, with grade 3/4 neutropenia in 51% of patients. Febrile neutropenia developed after nine courses (9%) and resulted in one treatment-related death. Cardiac toxicity and diarrhea, possibly specific for both agents, were infrequent and manageable.
Combination chemotherapy with irinotecan and amrubicin is effective in patients with NSCLC but showed moderate toxicities in second- or third-line settings.
现有抗癌药物作为复发性非小细胞肺癌（NSCLC）二线治疗的生存优势有限，需要进一步提高治疗效果。伊立替康联合氨柔比星治疗晚期 NSCLC 尚未得到充分评估。
本Ⅱ期临床试验的主要终点为客观缓解。招募了先前接受过一种或两种化疗药物治疗的 NSCLC 患者。伊立替康和氨柔比星分别在 21 天周期的第 1 天和第 8 天给药，剂量分别为 100mg/m²和 40mg/m²。
2004 年至 2006 年期间，31 名患者共接受了 101 个疗程；中位数为 3 个疗程（范围 1 至 6 个）。31 名患者中有 9 名获得了客观缓解（29.0%的缓解率；95%置信区间[CI]，12.1-46.0%）。中位随访时间为 43.9 个月，中位总生存期和中位无进展生存期分别为 14.2 个月和 4.0 个月。最常见的不良反应是骨髓抑制，51%的患者出现 3/4 级中性粒细胞减少症。9 个疗程（9%）发生发热性中性粒细胞减少症，导致 1 例与治疗相关的死亡。心脏毒性和腹泻可能与两种药物均相关，较为少见且可管理。
伊立替康联合氨柔比星治疗 NSCLC 有效，但在二线或三线治疗中显示出中度毒性。
