一项关于基于ERCC1和RRM1 mRNA表达的化疗与多西他赛/卡铂治疗晚期非小细胞肺癌的随机II期试验。
A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer.
作者信息
Heo Su Jin, Jung Inkyung, Lee Choong-Kun, Kim Jee Hung, Lim Sun Min, Moon Yong Wha, Shim Hyo Sup, Jeong Jaeheon, Kim Joo-Hang, Kim Hye Ryun, Cho Byoung Chul
机构信息
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-Gu, Seoul, 120-752, Korea.
Department of Biostatistics and Medical Informatics, Yonsei University College of Medicine, Seoul, Korea.
出版信息
Cancer Chemother Pharmacol. 2016 Mar;77(3):539-48. doi: 10.1007/s00280-016-2968-z. Epub 2016 Jan 25.
OBJECTIVES
To evaluate whether the selection of first-line chemotherapy based on ERCC1 and RRM1 mRNA expression levels would improve clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients.
MATERIALS AND METHODS
Eligible patients were randomly assigned 1:1 to the experimental and control arms; the experimental arm received gemcitabine/carboplatin (GC) if ERCC1 and RRM1 expression was low, gemcitabine/vinorelbine (GV) if ERCC1 was high and RRM1 was low, docetaxel/carboplatin (DC) if ERCC1 was low and RRM1 was high, and docetaxel/vinorelbine (DV) if both were high. In the control arm, patients received DC.
RESULTS
This study was prematurely terminated after the futility analysis of 43 progression-free survival (PFS) events. A total of 55 patients (n = 26 in the experimental arm, n = 29 in the control arm) were evaluable for efficacy and toxicity. Nineteen (73.1%) patients were assigned to receive GC, 0 (0.0%) to GV, 4 (15.4%) to DC, and 3 (11.5%) to DV in the experimental arm. The overall response rates were 42.3 and 48.3% in the experimental and control arms, respectively, which were not statistically different (P = 0.657). The median PFS was 5.2 months in the experimental arm and 5.4 months in the control arm (P = 0.286). The median overall survival was 17.4 months in the experimental arm and 12.6 months in the control arm (P = 0.638). The occurrence of grade 3 or higher neutropenia (69.2 vs. 93.1%, P = 0.035) and febrile neutropenia (3.8 vs. 24.1%, P = 0.054) was more common in the control arm.
CONCLUSION
ERCC1 and RRM1 mRNA expression-based chemotherapy did not improve clinical outcomes in advanced NSCLC (NCT01648517).
目的
评估基于ERCC1和RRM1 mRNA表达水平选择一线化疗方案是否能改善晚期非小细胞肺癌（NSCLC）患者的临床结局。
材料与方法
符合条件的患者按1:1随机分配至试验组和对照组；试验组中，若ERCC1和RRM1表达水平低则接受吉西他滨/卡铂（GC），若ERCC1高而RRM1低则接受吉西他滨/长春瑞滨（GV），若ERCC1低而RRM1高则接受多西他赛/卡铂（DC），若两者均高则接受多西他赛/长春瑞滨（DV）。对照组患者接受DC。
结果
在对43个无进展生存期（PFS）事件进行无效性分析后，本研究提前终止。共有55例患者（试验组26例，对照组29例）可进行疗效和毒性评估。试验组中，19例（73.1%）患者被分配接受GC，0例（0.0%）接受GV，4例（15.4%）接受DC，3例（11.5%）接受DV。试验组和对照组的总缓解率分别为42.3%和48.3%，差异无统计学意义（P = 0.657）。试验组的中位PFS为5.2个月，对照组为5.4个月（P = 0.286）。试验组的中位总生存期为17.4个月，对照组为12.6个月（P = 0.638）。3级或更高等级中性粒细胞减少症（69.2%对93.1%，P = 0.035）和发热性中性粒细胞减少症（3.8%对24.1%，P = 0.054）在对照组中更常见。
结论
基于ERCC1和RRM1 mRNA表达的化疗未改善晚期NSCLC患者的临床结局（NCT01648517）。
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