LBA30 - Elung: A Multicenter, Randomized Phase IIB Trial of “Standard” Platinum Doublets Plus Cetuximab (CET) as First-Line Treatment of Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

Abstract

ABSTRACT Background CET added to platinum doublet chemotherapy (chemo) improves survival in advanced NSCLC (Pirker R, et al. Lancet 2009). However, the optimal chemo combination with CET is not established for either squamous cell (SQ) or non-squamous (NSQ) histology. Arm (N) Median OS in months (95% CI) 1-year survival % (95% CI) NSQ SQ NSQ SQ PG + CET (236) 9.3 (7.3-12.2)* 7.1 (5.9-9.5)† 40.6 (32.8-50.1) 32.6 (24.3-44.0) CbPc + CET (233) 9.5 (7.0-12.5)* 9.6 (7.9-11.5)† 42.9 (35.1-52.4) 35.4 (27.0-46.5) PPm + CET (130) 10.6 (8.0-14.5)* N/A 47.3 (39.1-57.1) N/A Chemo + CET (599) 9.9 (8.3-11.4)¥ 8.7 (7.4-10.1)¥ 44.0 (39.0-49.0) 34.1 (28.0-42.0) * † Log-Rankp-value = 0.1863 Log-Rank p-value = 0.2570; ¥ Log-Rankp-value = 0.0082 Methods eLung was an open-label randomized phase II study in SQ & NSQ cohorts of patients (pts) with advanced NSCLC. Pts with NSQ were randomized to 1 of 3 treatment arms: cisplatin or carboplatin + either gemcitabine (PG) or pemetrexed (PPm); or carboplatin + paclitaxel (CbPc). SQ pts were randomized to PG or CbPc. All pts received concurrent CET at initial/weekly dose of 400 mg/m2/250 mg/m2. Chemo + CET was given for up to six 3-week cycles; stable and responding pts continued CET 500 mg/m2 Q 2 week as maintenance. Primary endpoint was overall survival (OS). Results Between 12/08 and 5/11, 601 stage IIIb/IV chemo naive pts (399 NSQ and 202 SQ) were randomized from 97 centers. Baseline demographics in NSQ/SQ cohort: male 62/55%, median (range) age: 67 (45-89)/67 (35-86), 81/83% Caucasian, 13/9% African-American, 0.5/1.0% Asian, stage IIIb 7.2/4.5%, ECOG PS 0, 33/39% and ECOG PS 1, 67/60%. Median OS & 1-year survival are shown in Table 1. Grade 3/4/5 AEs in > 5% of pts included rash (8%), neutropenia (26%), thrombocytopenia (24%), anemia (11%), hypomagnesemia (5%), hypokalemia (5%), fatigue (8%), dehydration (5%) and dyspnea (5%). In exploratory analysis pts with grade > 3 rash had median OS of 14.0 months vs. 9.4 for lesser grade rash (p = .031). Conclusions No new safety signals for platinum doublets + CET were identified. There were no significant differences in outcome by chemo regimen. NSQ patients receiving chemo + CET have improved survival compared to SQ patients. Disclosure L.S. Schwartzberg: research support from Eli Lilly and BMS B. Bastos: Eli Lilly advisory board participation C. Langer: Eli Lilly advisory board participation M.A. Socinski: research support from Eli Lilly. All other authors have declared no conflicts of interest.