A patient-level meta-analysis of FOLFIRINOX for locally advanced pancreatic cancer
By M. Suker, Berend R. Beumer, E. Sadot, L. Marthey, J. Faris, E. Mellon, B. El-Rayes, A. Wang-Gillam, J. Lacy, P. Hosein and 10 more. The Lancet Oncology, 2016
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Summary Background Thirty-five percent of pancreatic cancer patients have unresectable locally advanced pancreatic cancer (LAPC) at diagnosis. Several studies have evaluated systemic chemotherapy with FOLFIRINOX for patients with LAPC. We report a patient-level meta-analysis of LAPC patients treated with FOLFIRINOX as first-line treatment. Methods A systematic literature search was performed in Embase, Medline (ovidSP), Web of Science, Scopus, PubMed Publisher, Cochrane, and Google Scholar. Studies evaluating FOLFIRINOX as first-line treatment for LAPC were included. The primary outcome was overall survival (OS) and secondary outcomes included progression free survival (PFS), and grade 3 or 4 adverse events. We collected patient-level data from all studies that reported survival outcomes. The Kaplan-Meier method was used for survival outcomes. Grade 3 or 4 adverse event rates and the percentage of subsequent (chemo)radiation or resection in eligible studies were pooled in a random effects model. Findings Thirteen eligible studies representing 689 patients were included of whom 355 had LAPC. Eleven studies, representing 315 LAPC patients, reported survival outcomes and were eligible for patient-level meta-analysis. The median OS ranged from 10·0 to 32·7 months across studies with a patient-level median OS of 24·2 months [95% CI: 21·6 - 26·8 months]. The median PFS ranged from 3·0 to 20·4 months across studies with a patient-level median PFS of 15·0 months [95% CI: 13·8 – 16·2 months]. In 10 studies representing 490 patients, 296 Grade 3 or 4 adverse events were reported (i.e. 60·4 events per 100 patients). No death was attributed to FOLFIRINOX toxicity. Subsequent treatments included (chemo)radiation (63·5%) and surgical resection (25·9%). Interpretation Patients with LAPC treated with FOLFIRINOX had a median OS of 24·2 months that is far superior to previously reported OS with gemcitabine. Future research should evaluate these promising results in a randomized controlled trial and determine which patients might benefit from (chemo)radiation or a resection after FOLFIRINOX.
View Paper: https://www.semanticscholar.org/paper/06636012320911ff1d9fa82e8c709a993c063fa7
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- Pancreatic Adenocarcinoma, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. (2021, methodology): “8).(121) An observational study including 101 patients with locally advanced unresectable disease who were treated with FOLFIRINOX as induction therapy showed that 29% of the sample (20% without administration of chemoradiation) had a reduction in tumor size of greater than 30%, and half of the pati”