Adjuvant FOLFIRINOX chemotherapy has become the standard of care for pancreatic cancer patients following the release of data from the Phase III PRODIGE 24/CCTG PA.6 trial.
The findings were presented at American Society of Clinical Oncology Annual Meeting (ASCO, 1–5 June 2018, IL, USA) and more recently at the ESMO 20th World Congress on Gastrointestinal Cancer (20–23 June, Barcelona, Spain).
The trial demonstrated that adjuvant FOLFIRINOX chemotherapy improved both overall survival and progression-free survival compared with gemcitabine among patients with surgically removed nonmetastatic pancreatic ductal adenocarcinoma.
“The FOLFIRINOX regimen should now be considered a new standard of care after pancreatic resection in patients with good performance status,” Thierry Conroy from the Institut de Cancerologie de Lorraine (France) stated, 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.
In order to determine the role of FOLFIRINOX in the adjuvant setting, this study 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.
Disease-free survival was 21.6 months with FOLFIRINOX vs. 12.8 months with gemcitabine, whilst the median overall survival was 54.4 months with FOLFIRINOX vs. 35 months with gemcitabine. 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 added.