mFOLFIRINOX After Resection May Lead to Improved Outcomes in Pancreatic Carcinoma

CHICAGO—A modified regimen of oxaliplatin, leucovorin, irinotecan, and 5-FU (mFOLFIRINOX) may more effectively improve survival outcomes among patients with metastatic pancreatic cancer post-resection compared with gemcitabine, according to findings presented at the 2018 American Society of Clinical Oncology Annual Meeting on Monday, June 4.¹

Previous studies have demonstrated that adjuvant FOLFIRINOX leads to better outcomes compared with gemcitabine among patients with pancreatic cancer and is the current standard of therapy for this population, but the treatment has been associated with high rates of toxicity. Researchers sought to determine if mFOLFIRINOX would maintain efficacy but involve less adverse events (AE) post-resection.

In the phase 3 PRODIGE 24/CCFTG PA.6 study (ClinicalTrials.gov Identifier: NCT01526135) researchers enrolled 493 patients with resected pancreatic ductal adenocarcinoma 3 to 4 weeks after R0/R1 resection. Patients were randomly assigned to receive gemcitabine for 6 28-day cycles or mFOLFIRINOX without a 5-FU bolus every 14 days for 12 cycles.

After a median follow-up of 33.6 months, the median disease-free survival (DFS) rate was 12.8 months (95% CI, 11.7-15.2) in the gemcitabine group compared with 21.6 months (95% CI, 17.5-26.7) in the mFOLFIRINOX group (hazard ratio [HR], 0.59; 95% CI, 0.47-0.74). The 3-year DFS rate was 21.4% (95% CI, 15.8-27.5) in the gemcitabine group, which was nearly doubled at 39.7% (95% CI, 32.8-46.6) in the mFOLFIRINOX group.

The median overall survival (OS) rate was 35.0 months (95% CI, 28.7-43.9) among patients treated with gemcitabine compared with 54.4 months (95% CI, 41.8-not reached [NR]) for patients treated with mFOLFIRINOX. The 3-year OS rate was 63.4% in the mFOLFIRINOX arm compared with 48.6% in the gemcitabine arm.

Median metastasis-free survival (MFS) was 17.7 months (95% CI, 14.2-21.5) and 30.4 months (95% CI, 21.7-NR) among patients in the gemcitabine and mFOLFIRINOX arms, respectively.

A greater rate of AEs, including diarrhea, sensory peripheral neuropathy, fatigue, and mucositis, were observed among patients treated with mFOLFIRINOX (75.5%) compared with gemcitabine (51.1%); both treatment groups had a grade 4 AE rate of 12%. One toxic death occurred in the gemcitabine group.

mFOLFIRINOX may have had a higher rate of AEs, but its superiority was observed in all predefined subgroups. The authors concluded that “mFOLFIRINOX should now be considered a new standard of care after pancreatic cancer resection in patients with good performance status, at least in Western countries.”

Read more of Cancer Therapy Advisor‘s coverage of the American Society of Clinical Oncology (ASCO) 2018 meeting by visiting the conference page.

Reference

1. Conroy T, Hammel P, Hebbar M, et al. Unicancer GI PRODIGE 24/CCTG PA.6 trial: A multicenter international randomized phase III trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas. Oral presentation at the American Society of Clinical Oncology 2018 Meeting; June 1-5, 2018. Chicago; IL.