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).
Bibliographical noteFunding Information:
This study was supported partly by Sanofi-Aventis Korea Ltd. and Sandoz Korea. This study was supported in part by the National Research Foundation of Korea (NRF) funded by the Korea government (MEST) (2012R1A2A2A01046927 to B.C.Cho) and by Korea Ministry of Environment (MOE) as “the Environmental Health Action Program” (2015001350002 to H.R. Kim).
© 2016 Springer-Verlag Berlin Heidelberg.
All Science Journal Classification (ASJC) codes
- Cancer Research
- Pharmacology (medical)