临床时讯 ＞ 临床研究
在最近的国际Ⅲ期研究中，经过4个周期铂类为基础的诱导化疗后，没有进展的晚期非小细胞肺癌（NSCLC）患者，随机接受了培美曲塞维持治疗或安慰剂。2012年3月的国际肺癌研究协会（IASLC）《胸科肿瘤学杂志》（Journal of Thoracic Oncology）发表了该回顾性、探索性、事后亚组分析比较培美曲塞或安慰剂治疗东亚患者与非东亚患者的结果。
J Thorac Oncol. 2012 Mar;7(3):567-573.
Efficacy and Safety of Pemetrexed Maintenance Therapy versus Best Supportive Care in Patients from East Asia with Advanced, Nonsquamous Non-small Cell Lung Cancer: An Exploratory Subgroup Analysis of a Global, Randomized, Phase 3 Clinical Trial.
Belani CP, Wu YL, Chen YM, Kim JH, Yang SH, Zhang L, Peterson P, Orlando M.
Penn State Hershey Cancer Institute, Hershey, Pennsylvania; Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China; Taipei Veterans General Hospital, School of Medicine, National Yang-Ming University, Taipei City, Taiwan, Republic of China; Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea; Korea Cancer Center Hospital, Seoul, Republic of Korea; Cancer Center of Sun Yat-Sen University, Guangzhou, People's Republic of China; #Eli Lilly and Company, Indianapolis, Indiana; and Eli Lilly Interamérica Inc., Buenos Aires, Argentina.
INTRODUCTION: In a recent global phase 3 trial, patients with advanced non-small cell lung cancer (NSCLC), who had not progressed after four cycles of platinum-based induction chemotherapy, were randomized to maintenance therapy with pemetrexed or placebo. The objective of this retrospective, exploratory, post hoc subgroup analysis was to compare outcomes of East Asian patients with non-East Asian patients treated with pemetrexed or placebo.
METHODS: Only patients with nonsquamous histology were analyzed. Patients were grouped by enrollment location (East Asian = China, Korea, or Taiwan; non-East Asian = all other countries). The Kaplan-Meier method was used to calculate median progression-free survival (PFS) and overall survival (OS) times. Hazard ratios (HRs) were calculated using unadjusted Cox proportional hazard models.
RESULTS: Of the 663 patients enrolled in the study, 481 patients had nonsquamous NSCLC: East Asian = 27% and non-East Asian = 73%. In the East Asian subgroup, there were more women, never smokers, and patients with adenocarcinoma. PFS was similar between the subgroups and significantly prolonged in patients treated with pemetrexed than placebo (median PFS: East Asian, 4.4 versus 1.6 months, HR = 0.42, p < 0.001; non-East Asian, 4.5 versus 2.8 months, HR = 0.45, p < 0.001). OS was numerically prolonged in East Asians (median OS: pemetrexed, 19.7 months; placebo, 16.4 months) compared with non-East Asians (pemetrexed, 13.2 months; placebo, 8.5 months). Pemetrexed was reasonably well tolerated with few severe adverse events reported.
CONCLUSION: The results of this subgroup analysis support pemetrexed as maintenance therapy for East Asian patients with advanced, nonsquamous NSCLC.