Journal of gastrointestinal cancer · 2026
Second-Line Systemic Therapy Following First-Line FOLFIRINOX or NALIRIFOX in Metastatic Pancreatic Ductal Adenocarcinoma: A Systematic Review and Meta-Analysis.
СтатьяСистематический обзорМетаанализОбзорНазвание и аннотация: Перевод в очереди
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Shaker Pouyan, Kamran Daniyaal, Du Lingling, Pant Shubham, Rogers Jane E, Mizrahi Jonathan D
Аннотация
PURPOSE: FOLFIRINOX and NALIRIFOX are now preferred first-line treatments for metastatic pancreatic ductal adenocarcinoma (mPDAC), yet optimal second-line therapy after frontline triplet chemotherapy remains unclear. Prior evidence largely addressed second-line treatment after gemcitabine-based first-line therapy, limiting relevance today. We conducted the first contemporary systematic review and meta-analysis of second-line therapy after frontline triplet chemotherapy.
METHODS: We searched MEDLINE, Embase, CINAHL, and PsycINFO through January 2026 for studies of second-line therapy after first-line FOLFIRINOX/NALIRIFOX in adults with advanced/metastatic PDAC. Two reviewers independently selected studies, extracted data, and assessed quality (ROBINS-I or RoB 2). Random-effects meta-analyses pooled median overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Registered in PROSPERO (CRD420251276176) per PRISMA 2020 guidelines.
RESULTS: Twenty-three studies (3888 patients) met inclusion criteria, mostly retrospective cohorts after first-line FOLFIRINOX. Pooled median OS from second-line initiation was 7.57 months (95% CI, 6.00-9.55); pooled median PFS was 3.18 months (95% CI, 2.74-3.68). Pooled ORR was 11.6%; pooled DCR was 47.8%. Combination gemcitabine-based regimens outperformed monotherapy, particularly with ECOG 0-1. The only randomized phase-III trial (GEMPAX) showed significantly improved PFS and ORR with gemcitabine plus paclitaxel versus gemcitabine alone, without significant OS benefit. ECOG performance status was the strongest outcome predictor.
CONCLUSION: This first contemporary synthesis of post-triplet second-line therapy in mPDAC shows meaningful benefit in carefully selected, fit patients. Gemcitabine-based combination therapy is a reasonable option for ECOG 0-1 patients, though treatment should remain individualized based on performance status, toxicity, and preference. These findings provide contemporary benchmarks for practice and future trials.
METHODS: We searched MEDLINE, Embase, CINAHL, and PsycINFO through January 2026 for studies of second-line therapy after first-line FOLFIRINOX/NALIRIFOX in adults with advanced/metastatic PDAC. Two reviewers independently selected studies, extracted data, and assessed quality (ROBINS-I or RoB 2). Random-effects meta-analyses pooled median overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Registered in PROSPERO (CRD420251276176) per PRISMA 2020 guidelines.
RESULTS: Twenty-three studies (3888 patients) met inclusion criteria, mostly retrospective cohorts after first-line FOLFIRINOX. Pooled median OS from second-line initiation was 7.57 months (95% CI, 6.00-9.55); pooled median PFS was 3.18 months (95% CI, 2.74-3.68). Pooled ORR was 11.6%; pooled DCR was 47.8%. Combination gemcitabine-based regimens outperformed monotherapy, particularly with ECOG 0-1. The only randomized phase-III trial (GEMPAX) showed significantly improved PFS and ORR with gemcitabine plus paclitaxel versus gemcitabine alone, without significant OS benefit. ECOG performance status was the strongest outcome predictor.
CONCLUSION: This first contemporary synthesis of post-triplet second-line therapy in mPDAC shows meaningful benefit in carefully selected, fit patients. Gemcitabine-based combination therapy is a reasonable option for ECOG 0-1 patients, though treatment should remain individualized based on performance status, toxicity, and preference. These findings provide contemporary benchmarks for practice and future trials.