1481 - 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.

Editorial Acknowledgement

We thank all caregivers, investigators, nurses, data manager for their active participation and involvement in this study.

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.