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Title: Outcomes in patients with aggressive or refractory disease from REVEL: A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non-small-cell lung cancer.
Authors: Reck, Martin
Paz-Ares, Luis
Bidoli, Paolo
Cappuzzo, Federico
Dakhil, Shaker
Moro-Sibilot, Denis
Borghaei, Hossein
Johnson, Melissa
Jotte, Robert
Pennell, Nathan A
Shepherd, Frances A
Tsao, Anne
Thomas, Michael
Carter, Gebra Cuyun
Chan-Diehl, Faye
Alexandris, Ekaterine
Lee, Pablo
Zimmermann, Annamaria
Sashegyi, Andreas
Pérol, Maurice
Keywords: Angiogenesis;Clinical trial;Docetaxel;Histology;Human monoclonal antibody;Non-small cell lung cancer (NSCLC);Phase 3 clinical trial;Ramucirumab;Refractory patients;Vascular endothelial growth factor (VEGF)
metadata.dc.subject.mesh: Adult
Aged, 80 and over
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Carcinoma, Non-Small-Cell Lung
Disease Progression
Drug Resistance, Neoplasm
Kaplan-Meier Estimate
Lung Neoplasms
Middle Aged
Neoplasm Staging
Quality of Life
Treatment Outcome
Young Adult
Issue Date: 5-Aug-2017
Abstract: The REVEL study demonstrated improved efficacy for patients with advanced non-small cell lung cancer treated with ramucirumab plus docetaxel, independent of histology. This exploratory analysis characterized the treatment effect in REVEL patients who were refractory to prior first-line treatment. Refractory patients had a best response of progressive disease to first-line treatment. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and safety. Kaplan-Meier and Cox proportional hazards regression were performed for OS and PFS, and Cochran-Mantel-Haenszel test was used for response. QoL was assessed with the Lung Cancer Symptom Scale. Sensitivity analyses were performed on subgroups of the intent-to-treat population with limited time on first-line therapy. Of 1253 randomized patients in REVEL, 360 (29%) were refractory to first-line treatment. Baseline characteristics were largely balanced between treatment arms. In the control arm, median OS for refractory patients was 6.3 versus 10.3 months for patients not meeting this criterion, demonstrating the poor prognosis of refractory patients. Median OS (8.3 vs. 6.3 months; HR, 0.86; 95% CI, 0.68-1.08), median PFS (4.0 vs. 2.5 months; HR, 0.71; 95% CI, 0.57-0.88), and ORR (22.5% vs. 12.6%) were improved in refractory patients treated with ramucirumab compared to placebo, without new safety concerns or further deteriorating patient QoL. The effect of ramucirumab in refractory patients is similar to that in the intent-to-treat population. The benefit/risk profile for refractory patients suggests that ramucirumab plus docetaxel is an appropriate treatment option even in this difficult-to-treat population.
metadata.dc.identifier.doi: 10.1016/j.lungcan.2017.07.038
Appears in Collections:Producción 2020

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