Subgroup Analysis from REVEL: Safety by Histology and Efficacy in Nonsquamous NSCLC
REVEL, a global, randomized phase 3 study inclusive of nonsquamous (NSQ) and squamous (SQ) NSCLC, led to FDA approval of second-line ramucirumab plus docetaxel (RAM+DOC) for patients with metastatic NSCLC based on improved overall survival (OS).a Neutropenia, febrile neutropenia, gastrointestinal, and pulmonary hemorrhage events were similar across NSQ and SQ histologies. In the presentation by Paz-Ares and colleagues,b a subanalysis of REVEL by histologic subgroups was shown in which 1,253 patients with SQ or NSQ NSCLC received DOC (75 mg/m2) plus RAM (10 mg/kg; N = 628) or placebo (N = 625) after disease progression on platinum-based therapy. Endpoints evaluated in specified histologic subgroups were OS, progression-free survival (PFS), response rates, safety, and quality of life (QoL) analyzed by time to deterioration (TtD) on the Lung Cancer Symptom scale (LCSS). Of the 73% (N = 912) of NSQ tumors, the majority were adenocarcinoma (79%; N = 725).
Efficacy outcomes for patients with adenocarcinoma were similar to the NSQ population (see Table). Incidences of patients with ? 1 treatment-emergent adverse event (TEAE), ? 1 serious adverse event, TEAEs grade ? 3, and TEAEs leading to dose adjustment or discontinuation were similar between treatment arms and across NSQ and SQ histologies. The TtD for total LCSS score was similar between treatment arms in NSQ and SQ subgroups. This subanalysis of REVEL demonstrated an acceptable benefit/risk profile for RAM+DOC, with favorable efficacy and manageable safety outcomes seen across SQ, adenocarcinoma, and NSQ histologic subtypes of NSCLC, with no impairment of QoL.
- Garon EB, et al. Lancet. 2014;384:665-673.
- Paz-Ares L, et al. ASCO 2015. Abstract 8055.