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Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial.

Authors
 Edward B Garon  ;  Tudor-Eliade Ciuleanu  ;  Oscar Arrieta  ;  Kumar Prabhash  ;  Konstantinos N Syrigos  ;  Tuncay Goksel  ;  Keunchil Park  ;  Vera Gorbunova  ;  Ruben Dario Kowalyszyn  ;  Joanna Pikiel  ;  Grzegorz Czyzewicz  ;  Sergey V Orlov  ;  Conrad R Lewanski  ;  Michael Thomas  ;  Paolo Bidoli  ;  Shaker Dakhil  ;  Steven Gans  ;  Joo-Hang Kim  ;  Alexandru Grigorescu  ;  Nina Karaseva  ;  Martin Reck  ;  Federico Cappuzzo 
Citation
 Lancet, Vol.384(9944) : 665-673, 2014 
Journal Title
 Lancet 
ISSN
 0140-6736 
Issue Date
2014
MeSH
Adult ; Aged ; Antibodies, Monoclonal/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/pathology ; Disease Progression ; Double-Blind Method ; Female ; Humans ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Neoplasm Staging ; Placebos ; Platinum ; Quality of Life ; Survival Rate ; Taxoids/administration & dosage
Abstract
BACKGROUND: Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2. We aimed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer (NSCLC) after platinum-based therapy. METHODS: In this multicentre, double-blind, randomised phase 3 trial (REVEL), we enrolled patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen. Patients were randomly allocated (1:1) with a centralised, interactive voice-response system (stratified by sex, region, performance status, and previous maintenance therapy [yes vs no]) to receive docetaxel 75 mg/m(2) and either ramucirumab (10 mg/kg) or placebo on day 1 of a 21 day cycle until disease progression, unacceptable toxicity, withdrawal, or death. The primary endpoint was overall survival in all patients allocated to treatment. We assessed adverse events according to treatment received. This study is registered with ClinicalTrials.gov, number NCT01168973. FINDINGS: Between Dec 3, 2010, and Jan 24, 2013, we screened 1825 patients, of whom 1253 patients were randomly allocated to treatment. Median overall survival was 10·5 months (IQR 5·1-21·2) for 628 patients allocated ramucirumab plus docetaxel and 9·1 months (4·2-18·0) for 625 patients who received placebo plus docetaxel (hazard ratio 0·86, 95% CI 0·75-0·98; p=0·023). Median progression-free survival was 4·5 months (IQR 2·3-8·3) for the ramucirumab group compared with 3·0 months (1·4-6·9) for the control group (0·76, 0·68-0·86; p<0·0001). We noted treatment-emergent adverse events in 613 (98%) of 627 patients in the ramucirumab safety population and 594 (95%) of 618 patients in the control safety population. The most common grade 3 or worse adverse events were neutropenia (306 patients [49%] in the ramucirumab group vs 246 [40%] in the control group), febrile neutropenia (100 [16%] vs 62 [10%]), fatigue (88 [14%] vs 65 [10%]), leucopenia (86 [14%] vs 77 [12%]), and hypertension (35 [6%] vs 13 [2%]). The numbers of deaths from adverse events (31 [5%] vs 35 [6%]) and grade 3 or worse pulmonary haemorrhage (eight [1%] vs eight [1%]) did not differ between groups. Toxicities were manageable with appropriate dose reductions and supportive care. INTERPRETATION: Ramucirumab plus docetaxel improves survival as second-line treatment of patients with stage IV NSCLC. FUNDING: Eli Lilly.
Full Text
http://www.sciencedirect.com/science/article/pii/S014067361460845X
DOI
10.1016/S0140-6736(14)60845-X
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Joo Hang(김주항)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/99575
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