European journal of cancer (Oxford, England : 1990) · 2026
Second-line liposomal irinotecan plus S-1 vs. liposomal irinotecan plus 5-fluorouracil in metastatic pancreatic cancer: The phase I/II randomized NAPAN trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыКлиническое исследование I фазыEquivalence TrialНазвание и аннотация: Перевод в очереди
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Gehrels Anne M, Pijnappel Esther N, van Daalen Eva H, Casalino Simona, Zechetto Camilla, Quinzii Alberto, Prager Gerald W, de Vos-Geelen Judith, Macarulla Teresa, Melisi Davide, Ali Mahsoem, Wilmink Johanna W
Аннотация
BACKGROUND: This study aimed to determine the optimal second-line treatment strategy in patients with metastatic pancreatic cancer, hypothesizing that liposomal irinotecan (nal-IRI) combined with S-1 would be superior to nal-IRI with 5-fluorouracil (5-FU)/leucovorin (LV).
METHODS: This was an international, multi-center, open-label, randomized phase I/II superiority trial. Patients with pancreatic adenocarcinoma, previously treated with gemcitabine-based treatment, were enrolled. Patients were randomly allocated to receive either nal-IRI plus S-1 (S-1 arm) or nal-IRI plus 5-FU/LV (5-FU arm). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), (serious) adverse events (SAEs), response rate, and health-related quality of life. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using a Cox model. This trial is registered with ClinicalTrials.gov (NCT03986294) and is completed.
RESULTS: Between November 10, 2021 and May 23, 2023, 120 patients were randomized to the S-1 arm (n = 61) or the 5-FU arm (n = 59). Three patients were excluded due to ineligibility. Median PFS was 2.2 months in the S-1 arm vs. 3.3 months in the 5-FU arm (HR 1.27; 95% CI 0.84-1.91, p = 0.26). Median OS was 6.0 months in the S-1 arm vs. 9.1 months in the 5-FU arm (HR 1.47; 95% CI 0.99-2.17, p = 0.054). The most common grade 3-4 AEs were diarrhea (13.8%) and nausea (10.3%) in the S-1 arm, and diarrhea (14.0%), asthenia and mucositis (both 7.0%) in the 5-FU arm.
CONCLUSION: Second-line treatment with nal-IRI plus S-1 did not improve PFS and OS compared to nal-IRI plus 5-FU/LV in patients with metastatic pancreatic cancer following first-line gemcitabine-based chemotherapy.
METHODS: This was an international, multi-center, open-label, randomized phase I/II superiority trial. Patients with pancreatic adenocarcinoma, previously treated with gemcitabine-based treatment, were enrolled. Patients were randomly allocated to receive either nal-IRI plus S-1 (S-1 arm) or nal-IRI plus 5-FU/LV (5-FU arm). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), (serious) adverse events (SAEs), response rate, and health-related quality of life. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using a Cox model. This trial is registered with ClinicalTrials.gov (NCT03986294) and is completed.
RESULTS: Between November 10, 2021 and May 23, 2023, 120 patients were randomized to the S-1 arm (n = 61) or the 5-FU arm (n = 59). Three patients were excluded due to ineligibility. Median PFS was 2.2 months in the S-1 arm vs. 3.3 months in the 5-FU arm (HR 1.27; 95% CI 0.84-1.91, p = 0.26). Median OS was 6.0 months in the S-1 arm vs. 9.1 months in the 5-FU arm (HR 1.47; 95% CI 0.99-2.17, p = 0.054). The most common grade 3-4 AEs were diarrhea (13.8%) and nausea (10.3%) in the S-1 arm, and diarrhea (14.0%), asthenia and mucositis (both 7.0%) in the 5-FU arm.
CONCLUSION: Second-line treatment with nal-IRI plus S-1 did not improve PFS and OS compared to nal-IRI plus 5-FU/LV in patients with metastatic pancreatic cancer following first-line gemcitabine-based chemotherapy.