RT Journal Article
T1 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.
A1 Reck, Martin
A1 Paz-Ares, Luis
A1 Bidoli, Paolo
A1 Cappuzzo, Federico
A1 Dakhil, Shaker
A1 Moro-Sibilot, Denis
A1 Borghaei, Hossein
A1 Johnson, Melissa
A1 Jotte, Robert
A1 Pennell, Nathan A
A1 Shepherd, Frances A
A1 Tsao, Anne
A1 Thomas, Michael
A1 Carter, Gebra Cuyun
A1 Chan-Diehl, Faye
A1 Alexandris, Ekaterine
A1 Lee, Pablo
A1 Zimmermann, Annamaria
A1 Sashegyi, Andreas
A1 Pérol, Maurice
K1 Angiogenesis
K1 Clinical trial
K1 Docetaxel
K1 Histology
K1 Human monoclonal antibody
K1 Non-small cell lung cancer (NSCLC)
K1 Phase 3 clinical trial
K1 Ramucirumab
K1 Refractory patients
K1 Vascular endothelial growth factor (VEGF)
AB 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.
YR 2017
FD 2017-08-05
LK http://hdl.handle.net/10668/11859
UL http://hdl.handle.net/10668/11859
LA en
DS RISalud
RD Apr 8, 2025