Adjuvant treatment with modified FOLFIRINOX can improve outcomes at 5 years, when compared with gemcitabine, in patients with resected pancreatic ductal adenocarcinoma (PDAC), according to research published in JAMA Oncology.
Final 5-year results from a phase 3 trial showed that mFOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil) can improve disease-free survival (DFS), cancer-specific survival, and overall survival (OS).
The trial included 493 patients with PDAC who had undergone complete macroscopic resection within 3 to 12 weeks before randomization. Patients were randomly assigned to receive mFOLFIRINOX (n=247) or gemcitabine (n=246) as adjuvant therapy for 24 weeks.
The median follow-up was 69.7 months. The median duration of treatment was 24.6 weeks in the mFOLFIRINOX arm and 24.0 weeks in the gemcitabine arm.
The median DFS was 21.4 months in the mFOLFIRINOX arm and 12.8 months in the gemcitabine arm (hazard ratio [HR], 0.66; 95% CI, 0.54-0.82; P <.001). The 5-year DFS rate was 26.1% and 19.0%, respectively.
“The median disease-free survival of 21.4 months with mFOLFIRINOX is, to our knowledge, one of the longest reported in randomized clinical trials of adjuvant therapy in resected PDAC and was 8.6 months longer than in gemcitabine group,” the researchers wrote. “It seems unlikely that the difference between treatment groups was because of a patient selection bias, as the median disease-free survival of 12.8 months in the gemcitabine group aligns with other trials.”
The researchers also found a 32% reduction in the risk of death with mFOLFIRINOX compared with gemcitabine. The median OS was 53.5 months with mFOLFIRINOX and 35.5 months with gemcitabine (HR, 0.68; 95% CI, 0.54-0.85; P =.001).
In addition, metastasis-free survival and cancer-specific survival were significantly longer with mFOLFIRINOX than with gemcitabine. The median metastasis-free survival was 29.4 months and 17.7 months, respectively (HR, 0.64; 95% CI, 0.52-0.80; P <.001). The median cancer-specific survival was 54.7 months and 36.6 months, respectively (HR, 0.65; 95% CI, 0.51-0.82; P <.001).
“[m]FOLFIRINOX adjuvant chemotherapy significantly improves OS after complete resection of PDAC compared with single-agent adjuvant gemcitabine,” the researchers wrote. “The benefits were seen across all survival endpoints in all predefined subgroups. These findings confirm treatment with mFOLFIRINOX as the recommended adjuvant regimen in eligible patients.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Conroy T, Castan F, Lopez A, et al. Five-year outcomes of FOLFIRINOX vs gemcitabine as adjuvant therapy for pancreatic cancer. A randomized clinical trial. JAMA Oncol. Published online September 1, 2022. doi:10.1001/jamaoncol.2022.3829