Περίληψη:
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.
Συγγραφείς:
Paz-Ares, Luis G.
Perol, Maurice
Ciuleanu, Tudor-Eliade and
Kowalyszyn, Ruben Dario
Reck, Martin
Lewanski, Conrad R. and
Syrigos, Konstantinos
Arrieta, Oscar
Prabhash, Kumar
Park,
Keunchil
Pikiel, Joanna
Goksel, Tuncay
Lee, Pablo and
Zimmermann, Anna
Carter, Gebra Cuyun
Alexandris, Ekaterine and
Garon, Edward B.
