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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 
 Cancer Chemotherapy and Pharmacology, Vol.77(3) : 539-548, 2016 
Journal Title
 Cancer Chemotherapy and Pharmacology 
Issue Date
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Carboplatin/administration & dosage ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; DNA-Binding Proteins/genetics* ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Disease-Free Survival ; Endonucleases/genetics* ; Female ; Gene Expression Regulation, Neoplastic ; Humans ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Male ; Middle Aged ; RNA, Messenger/metabolism ; Survival Rate ; Taxoids/administration & dosage ; Treatment Outcome ; Tumor Suppressor Proteins/genetics* ; Vinblastine/administration & dosage ; Vinblastine/analogs & derivatives ; Young Adult
Chemotherapy ; ERCC1 ; Non-small cell lung cancer ; RRM1 ; mRNA expression
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).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Shim, Hyo Sup(심효섭) ORCID logo https://orcid.org/0000-0002-5718-3624
Lim, Sun Min(임선민)
Jung, Inkyung(정인경) ORCID logo https://orcid.org/0000-0003-3780-3213
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
Heo, Su Jin(허수진) ORCID logo https://orcid.org/0000-0002-0615-5869
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