Multicenter randomized, open-label phase II trial of sequential erlotinib and gemcitabine compared with gemcitabine monotherapy as first-line therapy in elderly or ECOG PS two patients with advanced NSCLC

• DOI: 10.1111/ajco.12178
• Publication Date: 2014-02-28T02:00:49Z
• Authors: Michael Michael; Shane C White; Ehtesham Abdi; Louise Nott; Phillip Clingan; Allan Zimet; Peter Button; Daniel Gregory; Benjamin Solomon; Alexander Dobrovic; Hongdo Do; Stephen Clarke
• Keywords: Open label; Erlotinib Hydrochloride

Aim The potential beneficial interaction between erlotinib and chemotherapy may require sequencing or pharmacodynamic separation. aim of this study was to evaluate the efficacy tolerance sequential gemcitabine versus monotherapy as first-line therapy in elderly ECOG PS-2 patients with advanced non-small cell lung carcinoma. Methods primary objective multicenter randomized Phase II progression-free survival (PFS). Secondary objectives were overall response rate (ORR), disease control rate, duration, safety. Patients either (1250 mg/m2 Day 1, 8 q28 days) followed by (150 mg/day on day 15 through 28), (EG-arm), (1000 Days 8, days), (G-arm) for up six cycles. Results Fifty-four recruited, 28 G-arm 26 EG-arm. Overall, results not significantly different arms. Median PFS ORR G- EG-arms 8.0 10.3 weeks (hazard ratio 1.3; 95% confidence interval [0.63;2.68]; P = 0.48) 7.1 3.8 percent respectively (difference −3.30; [−17.5;10.9]). majority adverse events (AEs) both arms Grade 1–2. commonest AEs recorded EG- G-arms rash-like (65 percent) nausea (42 respectively. Four (17 EG-arm five (16 experienced at least one treatment-related serious AE. Conclusions In study, carcinoma aged ≥70 years derived no advantage from combination relative alone. No unexpected safety findings noted.