A phase II randomised trial of induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer: the Taiwan Cooperative Oncology Group T2212 study
Mené en Chine entre 2013 et 2019 sur 55 patients atteints d'un adénocarcinome pancréatique localement avancé, cet essai randomisé de phase II évalue l'efficacité, du point de vue du taux de survie sans progression à 9 mois, et la sécurité d'un traitement comportant une chimiothérapie d'induction de type GOFL (gemcitabine, oxaliplatine plus fluorouracile (5-FU)/leucovorine) ou de type FOLFIRINOX modifié (irinotécan, oxaliplatine plus 5-FU/leucovorine) et une radiochimiothérapie concomitante
Background: The objective of this study was to evaluate the efficacy and safety of induction chemotherapy (ICT), GOFL (gemcitabine, oxaliplatin plus fluorouracil (5-FU)/leucovorin) versus modified FOLFIRINOX (irinotecan, oxaliplatin plus 5-FU/leucovorin), followed by concurrent chemoradiotherapy (CCRT) in locally advanced pancreatic adenocarcinoma (LAPC). Methods: Chemo-naive patients with measurable LAPC were eligible and randomly assigned to receive biweekly ICT with either mFOLFIRINOX or GOFL for 3 months. Patients without systemic progression would have 5-FU- or gemcitabine-based CCRT (5040 cGy/28 fractions) and were then subjected to surgery or continuation of chemotherapy until treatment failure. The primary endpoint was 9-month progression-free survival (PFS) rate. Results: Between July 2013 and January 2019, 55 patients were enrolled. After ICT, 21 (77.8%) of 27 patients who received mFOLFIRINOX and 17 (60.7%) of 28 patients who received GOFL completed CCRT. Of them, one and five had per-protocol R0/R1 resection. On intent-to-treat analysis, the 9-month PFS rate, median PFS and overall survival in mFOLFIRINOX and GOFL arms were 30.5% versus 35.9%, 6.6 (95% confidence interval: 5.9–12.5) versus 7.6 months (3.9–12.3) and 19.6 (13.4–22.9) versus 17.9 months (13.4–23.9), respectively. Grade 3–4 neutropenia and diarrhoea during induction mFOLFIRINOX and GOFL were 37.0% versus 21.4% and 14.8% versus 3.6%, respectively. Conclusion: Induction GOFL and mFOLFIRINOX followed by CCRT provided similar clinical outcomes in LAPC patients.