A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer

Su Jin Heo, Inkyung Jung, Choong Kun Lee, Jee Hung Kim, Sun Min Lim, Yong Wha Moon, Hyo Sup Shim, Jaeheon Jeong, Joo Hang Kim, Hye Ryun Kim, Byoung Chul Cho

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)539-548
Number of pages10
JournalCancer Chemotherapy and Pharmacology
Volume77
Issue number3
DOIs
Publication statusPublished - 2016 Mar 1

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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