TY - JOUR
T1 - Outcomes in patients with aggressive or refractory disease from REVEL
T2 - A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non-small-cell lung cancer
AU - Reck, Martin
AU - Paz-Ares, Luis
AU - Bidoli, Paolo
AU - Cappuzzo, Federico
AU - Dakhil, Shaker
AU - Moro-Sibilot, Denis
AU - Borghaei, Hossein
AU - Johnson, Melissa
AU - Jotte, Robert
AU - Pennell, Nathan A.
AU - Shepherd, Frances A.
AU - Tsao, Anne
AU - Thomas, Michael
AU - Carter, Gebra Cuyun
AU - Chan-Diehl, Faye
AU - Alexandris, Ekaterine
AU - Lee, Pablo
AU - Zimmermann, Annamaria
AU - Sashegyi, Andreas
AU - Pérol, Maurice
N1 - Publisher Copyright:
© 2017 The Authors
PY - 2017/10
Y1 - 2017/10
N2 - Objectives 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. Materials and methods 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. Results 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. Conclusions 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.
AB - Objectives 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. Materials and methods 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. Results 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. Conclusions 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.
KW - Angiogenesis
KW - Clinical trial
KW - Docetaxel
KW - Histology
KW - Human monoclonal antibody
KW - Non-small cell lung cancer (NSCLC)
KW - Phase 3 clinical trial
KW - Ramucirumab
KW - Refractory patients
KW - Vascular endothelial growth factor (VEGF)
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U2 - 10.1016/j.lungcan.2017.07.038
DO - 10.1016/j.lungcan.2017.07.038
M3 - Article
C2 - 29191593
AN - SCOPUS:85028455397
SN - 0169-5002
VL - 112
SP - 181
EP - 187
JO - Lung Cancer
JF - Lung Cancer
ER -