Oxaliplatin and/or gemcitabine vs. FOLFIRINOX in first-line Advanced pancreatic adenocarcinoma: Real-world efficacy and safety data of moroccan patients.

BACKGROUND

While fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) offers a survival advantage in advanced pancreatic adenocarcinoma (PAC) compared to gemcitabine, gemcitabine-oxaliplatin, and gemcitabine-nab-paclitaxel, the outcome of these regimens in African countries is still ignored in the literature.

METHODS

Data from a single academic centre in Morocco were analysed, focusing on unresectable PAC patients treated with FOLFIRINOX, gemcitabine, or gemcitabine-oxaliplatin between January 1st, 2015, and December 31st, 2022. The primary endpoints reported were progression-free survival (PFS) and overall survival (OS), with the safety profile being the secondary endpoint assessed.

RESULTS

In the analysis, 155 patients were considered eligible. As of the data cutoff point, the median follow-up was 20 (IQR: 6, 25) months, the median PFS was 12 (95 % confidence interval [CI], 8.8 to Not Estimable [NE]) months in the FOLFIRINOX group, 4.1 (95 % CI, 3.2 to 6.5) months in the gemcitabine group, and 4.8 (95 % CI: 4 to 7.5) months in the gemcitabine-oxaliplatin group (adjusted hazard ratio [aHR] for progression or death: 0.34; 95 % CI, 0.18 to 0.66; P = 0.002). At one year, the PFS rate achieved 52 % (95 % CI, 32 to 86) in the FOLFIRINOX group, 15 % (95 % CI, 7.1 to 32) in the gemcitabine group, and 12 % (95 % CI, 5.5 to 27) in the gemcitabine-oxaliplatin group. The median OS was 19 (95 % CI, 10 to NE) months in the FOLFIRINOX group, 7.3 (95 % CI, 4.7 to 15) months in the gemcitabine group, and 7.7 (95 % CI, 6.6 to 12) months in the gemcitabine-oxaliplatin group (aHR for death, 0.48; 95 % CI, 0.3 to 0.61; P = 0.01). The 18-month OS achieved 56 % (95 % CI, 34 to 100) in the FOLFIRINOX group, 11 % (95 % CI, 2.4 to 54) in the gemcitabine group, and 24 % (95 % CI, 13 to 46) in the gemcitabine-oxaliplatin group. The grade 3-4 adverse event incidence across treatment groups was mostly presented as hematologic, while the incidence was non-hematologic except for one case of diarrhoea in the gemcitabine group.

CONCLUSION

FOLFIRINOX was significantly associated with better survival compared to other regimens with tolerable side effects, all with a lack of longer-term benefits from either regimen. All of these findings point to possible treatment-specific efficacy correlates that could be used to select further patient populations for later trials since it is the first study of its kind in the African region.