Randomised Phase II Trial of Oral Vinorelbine (OV) and Cisplatin (P) Followed by Maintenance with OV Versus Gemcitabine (GEM) and P Followed by Maintenance with GEM As First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients (pts) with Squamous (sq) Histological Type

Background: The doublets OV+P and GEM+P are among standard treatment options in NSCLC. The study aims to assess efficacy, safety of OV+P (Arm A) and GEM+P (Arm B), followed by maintenance with OV or GEM respectively. Methods: Pts were randomised to receive (every 3-week cycles): OV at 80 mg/m² D1 and D8 (60 mg/m² Cycle 1) + P 80 mg/m² D1 or GEM 1250 mg/m² (D1 and D8) + P 75 mg/m² D1. After 4 cycles of combination, pts without progressive disease received single agent OV or GEM respectively as maintenance until progression or unacceptable toxicity. Primary endpoint: Disease Control Rate (DCR) on study treatment period (combination, maintenance). Secondary endpoints: safety, efficacy, quality of life. Results: 113 pts were included between 2013-2015 in intent-to-treat population (ITT). Baseline: 57 pts (Arm A)/ 56 pts (Arm B), median age of 61 and 64.5 years, stage IV 96.5% and 91.1% respectively. In Arm A/ B, 57 pts and 56 were treated in combination period; in maintenance, 29 and 28 pts were treated with OV or Gem. Final results (ITT) for study treatment period in Arm A/ B: DCR 73.7% [95%, CI (62.4; 100.0)] and 75% [95%, CI (63.7; 100.0)]. Median duration of treatment 12.1 and 13.2 weeks; objective response 24.6% [14.1; 37.8] and 30.4% [18.8; 44.1]; median [95% CI] duration of disease control in months (mo) 4.8 [4.1-5.7] and 5.2 [4.3-6.6]; median PFS: 4.2 (2.8-4.9) and 4.3 (3.1-5.5) mo; median survival: 10.2 (6.9-12.9) and 8.4 (5.3-11.9) mo. Total of any grades (Gr) of related adverse events (r-AEs) arm A/ B respectively: 87.7% and 92.9%. Any grade of related infections: 1.8% vs 8.9%.Gr 3-4 of selected r-AEs: nausea/vomiting 1.8%/3.5% vs 8.9%/ 5.4%, peripheral neuropathy 0% vs1.8%, renal failure 1.8% vs 3.6%, septic shock 0 vs 1.8%. Grade 1-2 related alopecia (8.8% vs 21.4%). One toxic death in each arm. Biological toxicities of gr 3-4 neutropenia 43.9%/37.5%, anaemia 17.5%/10.7%, thrombocytopenia 1.8%/10.7%. Full results to be presented at the meeting. Conclusions: This study confirms efficacy, safety of OV+P in sq NSCLC with a trend for a better median survival for OV+P. Clinical trial identification: EUDRACT NUMBER: 2012-003531-40. Legal entity responsible for the study: Pierre Fabre Médicament. Funding: Pierre Fabre Médicament. Disclosure: F. Grossi: Consulting, advisory role: Pierre Fabre, BMS, MSD, Roche. E. Pichon: Consulting, advisory role: BMS, AstraZeneca; Travel/accomodation, expenses: Astrazeneca, BMS. G. Czyzewicz: Honoraria: Roche, BMS, AstraZeneca; Consulting, advisory board: AstraZeneca, BMS, MSD, Roche; Research funding: BMS, Roche, AstraZeneca, Pierre Fabre Medicament; Expert testimony, Astrazeneca; Travel/accomodation: AstraZeneca, Roche, Pfizer. J. Bosch Barrera: Consulting, advisory boards: Pierre Fabre, BMS, Roche, AstraZeneca, Boehringer Ingelheim. C. Ta Thanh Minh: Employment pharmaceutical industry (PFM); Other ownership interest; Research project (PFM); Travel/accommodation. S. Gautier, H. Hervieu, S. Henriet: Employment, stocker/other ownership, research funding: Pierre Fabre. G. De Castro Jr.: Consulting or advisory role: Teva, Pfizer, Bayer, Roche, MSD; Speakers' bureau: AstraZeneca, Bayer, Novartis, Roche, MSD, BMS, Merck; Travels expenses: MSD, Novartis, Pfizer, AstraZeneca, Roche; Boehringer Ingelheim; Honoraria: AstraZeneca, Pfizer, MSD. All other authors have declared no conflicts of interest.