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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

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Garon, Edward B, Ciuleanu, Tudor-Eliade, Arrieta, Oscar, Prabhash, Kumar, Syrigos, Konstantinos N, Goksel, Tuncay, Park, Keunchil, Gorbunova, Vera, Kowalyszyn, Ruben Dario, Pikiel, Joanna, Czyzewicz, Grzegorz, Orlov, Sergey V, Lewanski, Conrad R, Thomas, Michael, Bidoli, Paolo, Dakhil, Shaker, Gans, Steven, Kim, Joo-Hang, Grigorescu, Alexandru, Karaseva, Nina, Reck, Martin, Cappuzzo, Federico, Alexandris, Ekaterine, Sashegyi, Andreas, Yurasov, Sergey, Pérol, Maurice·2014·The Lancet

DOI 10.1016/s0140-6736(14)60845-x

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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.

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A Randomized, Double-Blind, Phase III Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non–Small-Cell Lung Cancer After Disease Progression After 1 Previous Platinum-Based Therapy (REVEL): Treatment Rationale and Study Design
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A multicenter, double-blind, randomized phase III trial of ramucirumab plus docetaxel versus placebo plus docetaxel for treatment of Stage IV non-small cell lung cancer after disease progression on or after platinum-based therapy (REVEL): An Indian patient subgroup analysis
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A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy
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Update of REVEL: A randomized, double-blind, phase III study of docetaxel (DOC) and ramucirumab (RAM; IMC-1121B) versus DOC and placebo (PL) in the second-line (2L) treatment of stage IV non-small cell lung cancer (NSCLC) including subgroup analysis of histology
Bidoli, P., Cappuzzo, F., Favaretto, A. G., Alabiso, O., Tiseo, M., Chella, A., Gebbia, V., Pizzuti, L., Paz-Ares, L. G., Pérol, M., et al. (2015) · Annals of Oncology · doi:10.1093/annonc/mdv343.04 · Cited by 2
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Authors: Garon, E. B., Ciuleanu, T.-E., Arrieta, O., Prabhash, K., Syrigos, K. N., Goksel, T., Park, K., Gorbunova, V., Kowalyszyn, R. D., Pikiel, J., Czyzewicz, G., Orlov, S. V., Lewanski, C. R., Thomas, M., Bidoli, P., Dakhil, S., Gans, S., Kim, J.-H., Grigorescu, A., Karaseva, N., Reck, M., Cappuzzo, F., Alexandris, E., Sashegyi, A., Yurasov, S., & Pérol, M.
Affiliations: University of California, Los Angeles (US)
Iuliu Hațieganu University of Medicine and Pharmacy (RO)
Instituto Nacional de Cancerología (MX)
Tata Memorial Hospital (IN)
Sotiria General Hospital (GR)
Samsung Medical Center (KR)
Russian Cancer Research Center NN Blokhin (RU)
Charing Cross Hospital (GB)
University Hospital Heidelberg (DE)
Azienda Ospedaliera San Gerardo (IT)
Cancer Center of Kansas (US)
Gemeinschaftskrankenhaus Herdecke (DE)
Yonsei University Health System (KR)
Institutul Oncologic Bucuresti (RO)
City Clinical Oncology Center (RU)
German Center for Lung Research (DE)
Ospedale di Livorno (IT)
Eli Lilly (United States) (US)
Corresponding author: Garon, Edward B
ORCID: Garon, Edward B
Ciuleanu, Tudor-Eliade
Arrieta, Oscar
Prabhash, Kumar
Park, Keunchil
Gorbunova, Vera
Pikiel, Joanna
Thomas, Michael
Dakhil, Shaker
Kim, Joo-Hang
Grigorescu, Alexandru
Reck, Martin
Cappuzzo, Federico
Sashegyi, Andreas
Yurasov, Sergey
Venue: The Lancet
Publisher: Elsevier BV
Published: 2014-08
Volume: 384
Issue: 9944
Pages: 665-673
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(14)60845-x
OpenAlex: W2140980839
Cited by: 1,309
References: 35
Citations by year: 2026: 57 · 2025: 71 · 2024: 116 · 2023: 102 · 2022: 110 · 2021: 97 · 2020: 108 · 2019: 102 · 2018: 106 · 2017: 148 · 2016: 155 · 2015: 115 · 2014: 19
FWCI: 116.89
Type: journal article
Language: en
Open access: green
www.sciencedirect.com
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
BOA (University of Milano-Bicocca) (submittedVersion)
YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: ramucirumab, docetaxel, non-small cell lung cancer, second-line therapy, VEGFR-2 inhibition, anti-angiogenic therapy, overall survival, progression-free survival, adverse events, drug safety, maintenance therapy, lung squamous cell carcinoma, non-squamous cell lung cancer
MeSH terms: Docetaxel, Ramucirumab, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Double-Blind Method, Female, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Placebos, Platinum, Quality of Life, Survival Rate, Disease Progression, Taxoids, Antibodies, Monoclonal, Humanized

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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

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