1617P - PRODIGE 29-UCGI 26 (NEOPAN): Quality of life results of a phase III randomised trial comparing chemotherapy with folfirinox (FFX) or gemcitabine (gem) in locally advanced pancreatic carcinoma (LAPC)

Background

Pancreatic carcinoma (PC) is an aggressive malignancy and the 4th cause of all cancer deaths worldwide. More than 30% of patients (pts) with PC are unresectable because of the local extension with a median overall survival (OS) of less than 1 year. FFX is superior to gem in the treatment of metastatic PC, in terms of OS and progression-free survival (PFS) but standard of care remains gem for LAPC.

Methods

Pts with histologically proven LAPC not suitable for surgery, WHO PS ≤1, no cardiac ischemia were eligible. Randomization was stratified by center, tumour localization (pancreas head yes/no), WHO PS (0 vs 1) and age (≤60 vs > 60 years [yrs]). Pts received FFX (every 14 days for 12 cycles) or Gem 1000 mg/m² on days 1, 8, and 15 for six 28-day cycles excepted for cycle 1 with an infusion at D22. Primary endpoint was PFS. Secondary endpoints were OS, rate of secondary curative-intent surgery, objective response rate, disease control rate, time to treatment failure, quality of life (QoL) and safety. QoL outcomes and updated survival results since ESMO 2022 are presented here in the intent-to-treat population.

Results

A total of 171 pts aged 35-84 yrs were included and followed for maximum 5 yrs. With a median follow-up of 47.8 mo, 159 PFS events were observed. Median PFS was 9.7 mo (95% CI: 7.0; 11.7) vs 7.7 mo (95% CI: 6.2; 9.2) in FFX and gem arm respectively, stratified HR=0,71 (95% CI: 0.5; 1.00), p=.04 and median OS was 15.7 mo (95% CI: 11.9; 20.3) vs 14.9 mo (95% CI:11.7; 18.3), stratified HR=1.03 (95% CI: 0.73; 1.46), p=0.71. QoL was evaluated on 141 pts (68 in gem arm and 73 pts in FFX arm). No significant difference was observed between the two arms except on the diarrhea scale: rate of patients without deterioration was 50.4% (95% CI: 37.6.; 63.2) and 37.8% (95% CI: 25.9.; 51.5) in FFX arm vs 89,3% (95% CI: 78.5.; 95) and 63,2% (95% CI: 48.3.; 76) in Gem arm, at 3 and 6 mo respectively, p=0.002.

Conclusions

PRODIGE 29/NEOPAN trial results show that FFX yields significantly longer PFS compared to Gem and was well tolerated. No significant difference in OS and QoL was observed between both groups. More analysis are ongoing on QoL, and will be presented during ESMO meeting.

Clinical trial identification

NCT02539537.

Editorial acknowledgement

Legal entity responsible for the study

UNICANCER.

Funding

Institut National du Cancer (INCA) National League Against Cancer (Ligue contre le cancer).

Disclosure

M.P. Ducreux: Financial Interests, Personal, Invited Speaker: Roche, Amgen, Pierre Fabre, Merck Kga, Pfizer, Bayer, Lilly, Servier; Financial Interests, Personal, Advisory Board: Roche, Basilea, Sotio, Pierre Fabre, Boehringer Ingelheim, Rafael, Servier, Zymeworks, Ipsen, Bayer, HalioDX, Lilly, GSK, Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Funding, Partial funding of a trial evaluating the role of bevacizumab in NET: Roche; Financial Interests, Institutional, Funding, Partial funding of a trial evaluating the role of steptozotocin in NET: Keocyt; Financial Interests, Institutional, Local PI: Rafael, Amgen; Financial Interests, Institutional, Funding: Bayer; Other, Other, My wife is head of the oncology business unit in the French Affiliate of Sandoz: Sandoz France. F. Di Fiore: Financial Interests, Personal, Advisory Board: Amgen, BMS; Financial Interests, Personal, Invited Speaker: Merck, Bayer, Sanofi, Ipsen, AstraZeneca, Servier, Roche. L. Evesque: Financial Interests, Personal, Advisory Board: Servier, Amgen, MSD, Merck. J. Bachet: Non-Financial Interests, Personal, Advisory Board: Acobiom, Bayer, Biomunex, GSK, Merck, MSD, Pierre Fabre, Servier. T. Lecomte: Financial Interests, Personal, Invited Speaker: IPSEN, Pierre Fabre AstraZeneca, BMS; Financial Interests, Personal, Advisory Board: Sanofi, Merck, Servier, Amgen, Deciphera, Advanced Accelerator Applications, Pierre Fabre. O. Bouche: Financial Interests, Personal, Advisory Board: Amgen, Merck, Apmonia Therapeutics, Deciphera; Financial Interests, Personal, Invited Speaker: Servier, Pierre Fabre, Bayer. All other authors have declared no conflicts of interest.