NIP与EP方案一线治疗167例晚期复合性小细胞肺癌的回顾性分析

目的:比较NIP方案(长春瑞滨+异环磷酰胺+顺铂)和EP方案(依托泊苷+顺铂)一线治疗晚期复合性小细胞肺癌的疗效和不良反应.方法:回顾性分析2006年1月-2010年12月167例晚期复合性小细胞肺癌患者(Ⅲ～Ⅳ期),其中NIP方案组76例,EP方案组91例.所有患者均接受2～6周期的化疗.每2个化疗周期评价1次疗效.主要研究终点为总生存(overall survival,OS),次要研究终点为疾病无进展时间(progression-free survival,PFS)、客观有效率(objective response rate,ORR)和安全性.结果:NIP方案组ORR为28.9％ (22/76),EP方案组ORR为40.7％ (37/91),差异无统计学意义(P=0.115)；NIP方案组中位PFS为5.8个月,EP方案组中位PFS为6.5个月,差异无统计学意义(P=0.177)；NIP方案组中位生存期和1年OS分别为9.8个月和35.5％ (27/76),EP方案组中位生存期和1年OS分别为10.8个月和49.4％ (45/91),EP方案组较NIP方案组有更佳的生存获益,但差异无统计学意义(P=0.883,P=0.090).不良反应2组均可耐受,NIP方案组Ⅰ～Ⅱ度中性粒细胞减少和脱发发生率均高于EP方案组(32.9％ vs 11.0％,P＜0.001; 35.5％ vs 13.2％,P＜0.001).结论:NIP方案治疗晚期复合性小细胞肺癌的ORR、PFS和OS均略低于EP方案组,但差异无统计学意义；不良反应可以耐受.由此提示,对于3药联合化疗在晚期复合性小细胞肺癌中的地位和作用还有待商榷.

Navelbine-ifosfamide-cisplatin versus etoposide-cisplatin as the first-line treatment of advanced combined small-cell lung cancer:retrospective analysis of 167 cases

Objective:A retrospective study was performed to compare the efficacy and adverse effects between NIP regimen(navelbine + ifosfamide + cisplatin) and EP regimen(etoposide+cisplatin) as the first-line treatment of advanced combined small-cell lung cancer.Methods:A retrospective study was performed in 167 patients with advanced combined small-cell lung cancer(stages Ⅲ-Ⅳ) eligibly enrolled between January 2006 and December 2010.These patients received NIP regimen(n = 76) or EP regimen(n = 91) as the first-line treatment of advanced combined small-cell lung cancer.All the patients received 2-6 cycles of chemotherapy,and the response was evaluated every two cycles.The primary endpoint was overall survival(OS),and the secondary endpoints were progression-free survival(FPS),objective response rate(ORR) and adverse effects.Results:There was no significant difference in ORR between the NIP group(28.9%,22/76) and the EP group(40.7%,37/91)(P = 0.115).The median PFS of the EP group was little longer than that of the NIP group(6.5 vs 5.8 months,P = 0.177).The median survival and one-year survival rates of the NIP group and the EP group were 9.8 months and 35.6%(27/76),and 10.8 months and 49.4%(45/91),respectively;the EP regimen exerted a better survival benefit than the NIP regimen,but it failed to reach a statistical difference(P = 0.883;P = 0.090).The adverse effects of the two regimens could both be well tolerated.The rates of grade Ⅰ/Ⅱ leucopenia and alopecia for the NIP regimen were both significantly higher than those for the EP regimen(32.9% vs 11.0%,P<0.001;35.5% vs 13.2%,P<0.001).Conclusion:The ORR,PFS and OS for NIP regimen are little inferior to those of EP regimen as the first-line treatment of advanced combined small-cell lung cancer,but the differences are not significant.The toxicity of NIP regimen is less tolerable as compared with EP.Thus,the role of NIP regimen in the first-line treatment of advanced combined small-cell lung cancer need to be further comfirmed.