Modified FOLFIRINOX ‘recommended adjuvant regimen’ for patients with pancreatic cancer
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Adjuvant chemotherapy with modified FOLFIRINOX resulted in significantly longer survival vs. gemcitabine among patients with previously resected pancreatic ductal adenocarcinoma, according to 5-year data from a randomized phase 3 study.
Results of the PRODIGE 24/Canadian Cancer Trials Group PA6 trial — published in JAMA Oncology showed improvement in DFS, OS, metastasis-free survival and cancer-specific survival across all predefined subgroups.
Background
Surgical excision of pancreatic ductal adenocarcinoma is potentially curative, but the 5-year OS rate for surgery alone is approximately 10%, according to Thierry Conroy, MD, of the department of medical oncology at Institut de Cancérologie de Lorraine in Nancy, France, and colleagues. Randomized clinical trials have established treatment with a modified FOLFIRINOX regimen as the standard adjuvant chemotherapy after resection.
Conroy and colleagues conducted the 5-year follow-up analysis of the PRODIGE 24/Canadian Cancer Trials Group PA6 trial to confirm modified FOLFIRINOX as the standard of care compared with gemcitabine among patients with previously resected pancreatic cancer.
Methodology
The trial included 493 patients (mean age, 62 ± 8.9 years; 43.8% women) who underwent macroscopic resection of pancreatic ductal adenocarcinoma between April 16, 2012, and Oct. 3, 2016, at one of 77 hospitals in France and Canada.
Researchers randomly assigned patients in a 1:1 ratio to receive adjuvant therapy with either modified FOLFIRINOX (oxaliplatin dosed at 85 mg/m2 of body surface area, irinotecan at 150-180 mg/m2, leucovorin at 400 mg/m2 and fluorouracil at 2400 mg/m2, every 2 weeks) or gemcitabine (1,000 mg/m2 on days 1, 8 and 15, every 4 weeks) for 24 weeks.
DFS served as the primary endpoint. Secondary endpoints included OS, metastasis-free survival and cancer-specific survival. Investigators also determined prognostic factors for OS.
Median follow-up was 69.7 months as of the study cutoff date of June 28, 2021.
Key findings
Results showed median DFS of 21.4 months (95% CI, 17.5-26.7) among those who received modified FOLFIRINOX compared with 12.8 months (95% CI, 11.6-15.2) for those who received gemcitabine (HR = 0.66; 95% CI, 0.54-0.82).
Patients who received modified FOLFIRINOX vs. gemcitabine also had a higher 5-year DFS rate (26.1% vs. 19%), longer median OS (53.5 months vs. 35.5 months; HR = 0.68; 95% CI, 0.54-0.85) and a higher 5-year OS rate (43.2% vs. 31.4%), as well as longer median metastasis-free survival (29.4 months vs. 17.7 months; HR = 0.64; 95% CI, 0.52-0.8) and median cancer-specific survival (54.7 months vs. 36.3 months; HR = 0.65; 95% CI, 0.51-0.82).
A multivariable analysis suggested that significant favorable prognostic factors for OS included modified FOLFIRINOX, age, tumor grade, tumor staging and treatment at larger-volume centers, whereas adverse prognostic factors included shorter relapse delay.
Clinical implications
“With mature data and longer follow-up, the final results analysis of the PRODIGE 24/CCTG PA6 randomized clinical trial demonstrates that [modified] FOLFIRINOX adjuvant chemotherapy significantly improves OS after complete resection of [pancreatic ductal adenocarcinoma] compared with single-agent adjuvant gemcitabine,” Conroy and colleagues wrote. “These findings confirm treatment with [modified] FOLFIRINOX as the recommended adjuvant regimen in eligible patients.”
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