Cancer Res Treat.  2017 Jul;49(3):678-687. 10.4143/crt.2016.365.

ERCC1 Expression-Based Randomized Phase II Study of Gemcitabine/Cisplatin Versus Irinotecan/Cisplatin in Patients with Advanced Non-small Cell Lung Cancer

• Han JY
• Lee GK
• Lim KY
• Lee YJ
• Nam BH
• Lee JS

• KMID: 2388313
• DOI: http://doi.org/10.4143/crt.2016.365

Abstract

PURPOSE
We evaluated the clinical utility of excision repair cross-complementation group 1 (ERCC1) expression as a predictive biomarker for platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC).
MATERIALS AND METHODS
Eligible patients were randomly assigned to the GP (gemcitabine 1,250 mg/m² on days 1 and 8, and cisplatin 75 mg/m² on day 1 every 3 weeks) or IP (irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8 every 3 weeks) arm. The primary goal of this study was to compare the response rate (RR) of the GP and IP arms according to the ERCC1 expression level.
RESULTS
A total of 279 patients were randomly assigned to the GP (n=139) and IP (n=140) arms, among which 63% were ERCC1-positive and 268 patients were assessable for the RR. The GP and IP arms did not differ significantly with respect to the RR (29.8% vs. 27.0%, respectively; p=0.082), median progression-free survival (PFS; 4.5 months vs. 3.9 months, respectively; p=0.117), and overall survival (OS; 16.5 months vs. 16.7 months, respectively; p=0.313). When comparing the efficacy between the ERCC1-positive and ERCC1-negative groups, there was no significant difference in the RR (GP, 28.2% vs. 32.6%, respectively, p=0.509; IP, 30.2% vs. 21.6%, respectively, p=0.536), median PFS (GP, 4.6 months vs. 5.0 months, respectively, p=0.506; IP, 3.9 months vs. 3.7 months, respectively, p=0.748), or median OS (GP, 18.6 months vs. 11.9 months, respectively, p=0.070; IP, 17.5 months vs. 14.0 months, respectively, p=0.821).
CONCLUSION
Immunohistochemical analysis of the ERCC1 expression level did not differentiate the efficacy of platinum-based chemotherapy in advanced NSCLC.

Keyword

ERCC1; Platinum; Non-small-cell lung carcinoma

MeSH Terms

Arm
Carcinoma, Non-Small-Cell Lung*
Cisplatin
Disease-Free Survival
DNA Repair
Drug Therapy
Humans
Platinum
Cisplatin
Platinum

Figure

• 

  Fig. 1. CONSORT diagram. ERCC1, excision repair cross-complementation group 1; GP, gemcitabine and cisplatin; IP, irinotecan and cisplatin; PFS, progression-free survival; OS, overall survival.

Reference

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