CHICAGO — Adjuvant FOLFIRINOX chemotherapy improved OS and PFS compared with gemcitabine among patients with surgically removed nonmetastatic pancreatic ductal adenocarcinoma, according to data from the phase 3 PRODIGE 24/CCTG PA.6 trial presented at ASCO Annual Meeting.
“The FOLFIRINOX regimen should now be considered a new standard of care after pancreatic resection in patients with good performance status,” Thierry Conroy, MD, medical oncologist and director of the Institut de Cancerologie de Lorraine in France, said during a press conference.
For the past decade, 6 months of gemcitabine has been the standard adjuvant therapy after resection for pancreatic cancer. However, between 71% and 76% of patients relapse within 2 years.
FOLFIRINOX — composed of oxaliplatin, leucovorin, irinotecan and 5-FU — has been shown to be more effective than gemcitabine in the first-line setting for patients with metastatic pancreatic cancer with good performance status. However, its role in the adjuvant setting was unknown.
Researchers enrolled patients in France and Canada with nonmetastatic pancreatic ductal adenocarcinoma who underwent surgery for tumor removal. Within 3 months after surgery, researchers randomly assigned 493 patients to gemcitabine or FOLFIRINOX for 6 months.
DFS served as the primary outcome; secondary outcomes included OS, toxicity and specific-survival.
Median follow-up was 33.6 months.
Results showed median DFS was 21.6 months with FOLFIRINOX vs. 12.8 months with gemcitabine (HR = 0.58; 95% CI, 0.46-0.73).
Median OS was 54.4 months with FOLFIRINOX vs. 35 months with gemcitabine (HR = 0.64; 95% CI, 0.48-0.86). Time to metastases also was extended with FOLFIRINOX (median, 30.4 months vs. 17 months).
Researchers observed significantly more serious adverse events with FOLFIRINOX (76% vs. 30%). The most common treatment-related adverse events included diarrhea (18.6% vs. 3.7%), fatigue (11% vs. 4.6%) and sensory peripheral neuropathy (9.3% vs. 0). Of note, there was one treatment-related death in the gemcitabine arm and no deaths in the FOLFIRINIX arm.
“As expected, the FOLFIRINOX regimen is more toxic than gemcitabine, but it is a safe regimen with manageable toxicities” Conroy said. – by Jennifer Southall
Conroy T, et al. LBA4001. Presented at: ASCO Annual Meeting; June 1-5, 2018; Chicago.
Disclosures: Conroy reports travel accommodations or expenses from Roche. Please see the abstract for all other author’s relevant financial disclosures.