Ⅱ期研究：奈达铂和伊立替康联合胸部放疗治疗局部晚期非小细胞肺癌。
Phase II study of nedaplatin and irinotecan with concurrent thoracic radiotherapy in patients with locally advanced non-small-cell lung cancer.
机构信息
Department of Thoracic Oncology, Kanagawa Cancer Center, Nakao 1-1-2, Asahi-ku, Yokohama 241-0815, Japan.
出版信息
Br J Cancer. 2010 Oct 26;103(9):1325-30. doi: 10.1038/sj.bjc.6605875. Epub 2010 Oct 12.
BACKGROUND
Current international guidelines recommend the use of platinum-based chemotherapy with thoracic radiotherapy (TRT) for patients with locally advanced non-small-cell lung cancer (NSCLC).
METHODS
Patients with unresectable stage IIIA or IIIB NSCLC were treated with nedaplatin (NP) at 50 mg m(-2) and irinotecan (CPT) at 60 mg m(-2) on days 1 and 8 every 4 weeks for two to four cycles with concurrent TRT (2 Gy per day, total 60 Gy).
RESULTS
All 35 patients were able to receive a total of 60 Gy. Adverse effects and events in chemotherapy with TRT were grade 3 or 4 anaemia, neutropenia and thrombocytopenia, which occurred in 3.0%, 32.8% and 6.0% of patients, respectively. There was no grade 3 pneumonitis or oesophagitis. Adverse effects and events in chemotherapy alone were mild. There was no treatment-related death. An overall response rate was 94.3%. The median progression-free and overall survivals were 13.0 and 36.0 months, respectively. The 5-year disease-free and overall survival rates were 25.7% and 40.0%, respectively.
CONCLUSION
NP and CPT treatment with concurrent TRT is effective and safe for patients with unresectable, locally advanced NSCLC.
背景
目前国际指南建议对局部晚期非小细胞肺癌（NSCLC）患者使用含铂化疗联合胸部放疗（TRT）。
方法
对不可切除的 IIIA 或 IIIB 期 NSCLC 患者，使用奈达铂（NP）50mg/m²和伊立替康（CPT）60mg/m²，每 4 周 1 天和 8 天各用一次，连用 2-4 个周期，同时给予 TRT（2Gy/天，总剂量 60Gy）。
结果
所有 35 例患者均能接受 60Gy 总剂量。化疗联合 TRT 的不良反应和事件为 3 级或 4 级贫血、中性粒细胞减少和血小板减少，分别发生在 3.0%、32.8%和 6.0%的患者中。无 3 级肺炎或食管炎。单纯化疗的不良反应较轻。无治疗相关死亡。总的客观缓解率为 94.3%。中位无进展生存期和总生存期分别为 13.0 和 36.0 个月。5 年无病生存率和总生存率分别为 25.7%和 40.0%。
结论
NP 和 CPT 联合 TRT 治疗不可切除的局部晚期 NSCLC 是有效且安全的。
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