TY - JOUR
TI - Treatment outcomes by histology in REVEL: A randomized phase III trial
of Ramucirumab plus docetaxel for advanced non-small cell lung cancer
AU - Paz-Ares, Luis G.
AU - Perol, Maurice
AU - Ciuleanu, Tudor-Eliade and
AU - Kowalyszyn, Ruben Dario
AU - Reck, Martin
AU - Lewanski, Conrad R. and
AU - Syrigos, Konstantinos
AU - Arrieta, Oscar
AU - Prabhash, Kumar
AU - Park,
AU - Keunchil
AU - Pikiel, Joanna
AU - Goksel, Tuncay
AU - Lee, Pablo and
AU - Zimmermann, Anna
AU - Carter, Gebra Cuyun
AU - Alexandris, Ekaterine and
AU - Garon, Edward B.
JO - Translational Lung Cancer Research
PY - 2017
VL - 112
TODO - null
SP - 126-133
PB - Elsevier Ireland Ltd
SN - null
TODO - 10.1016/j.lungcan.2017.05.021
TODO - Non-small-cell lung cancer; Histology; Ramucirumab; Docetaxel
TODO - Objectives: Ramucirumab, a recombinant human immunoglobulin G1
monoclonal antibody inhibiting vascular endothelial growth factor
receptor-2, increased overall survival (OS) combined with docetaxel
versus docetaxel alone in non-small cell lung cancer (NSCLC) in the
REVEL trial. Pre-specified exploratory analysis examined efficacy and
safety by histology.
Materials and methods: 1253 patients with NSCLC were randomized to
receive ramucirumab (10 mg/kg; n = 628) plus docetaxel (75 mg/m(2)) or
placebo plus docetaxel (n = 625) after disease progression on or after
platinum-based therapy, with or without bevacizumab or maintenance
therapy. OS was analyzed using Kaplan-Meier method. Hazard ratios (HRs)
and 95% confidence intervals (CIs) were obtained using an unstratified
Cox proportional hazards model. Primary quality-of-life analysis was
time to deterioration (TtD) of the Lung Cancer Symptom Scale (LCSS)
scores using the Kaplan-Meier method and Cox regression.
Results: Median OS for adenocarcinoma was 11.2 months for
ramucirumab-docetaxel (n = 377) and 9.8 months for placebo-docetaxel (n
= 348); HR = 0.83 (95% CI: 0.69-0.99). In squamous disease, median OS
was 9.5 months for ramucirumab-docetaxel (n = 157) versus 8.2 months for
placebo-docetaxel (n = 171); HR 0.88 (95% CI: 0.69-1.13). Median OS for
other nonsquamous was 10.8 months for ramucirumab-docetaxel (n = 74) and
9.3 months for placebo-docetaxel (n = 78); HR = 0.86 (95% CI:
0.59-1.26). Treatment-emergent adverse events were comparable between
treatment arms across histologic subgroups. TtD for LCSS scores was
similar between treatment arms in the nonsquamous and squamous
subgroups.
Conclusion: REVEL demonstrated similar favorable efficacy and manageable
safety for ramucirumab-docetaxel across histologic subgroups of NSCLC.
ER -