Nab -Paclitaxel plus Gemcitabine and FOLFOX in Metastatic Pancreatic Cancer

• DOI: 10.1056/evidoa2300144
• Publication Date: 2024-01-23T14:30:19Z
• Authors: Alfredo Carrato; Roberto Pazo-Cid; Teresa Macarulla; Javier Gallego; Paula Jiménez-Fon...; Fernando Rivera; Maria Teresa Cano; Mercedes Rodrigue...; Carles Pericay; Inmaculada Alés; Laura Layos; Begoña Graña; Vega Iranzo; Inmaculada Gallego; Rocio Garcia-Carb...; Inmaculada Ruiz d...; Carmen Guillén-Ponce; Enrique Aranda
• Keywords: Clinical endpoint

BackgroundSequential nab-paclitaxel plus gemcitabine followed by modified FOLFOX-6 (oxaliplatin, leucovorin, and 5-fluorouracil) (nab-P/Gem-mFOLFOX) showed a good safety clinical profile in metastatic pancreatic ductal adenocarcinoma (mPDAC) the phase I SEQUENCE trial.MethodsThe efficacy of sequential nab-P/Gem-mFOLFOX was compared with standard (nab-P/Gem) as first-line treatment multi-institutional, randomized, open-label, II trial patients untreated mPDAC. We randomly assigned 1:1 ratio to receive nab-P/Gem on days 1, 8, 15 mFOLFOX day 29 6-week cycle (experimental group) or 4-week (control group). The primary end point 12-month overall survival rate.ResultsA total 157 were assigned: 78 79 nab-P/Gem. Patients receiving had 55.3% (95% confidence interval [CI], 44.2 66.5) versus 35.4% CI, 24.9 46) control group (P=0.02). Similarly, 24-month 22.4% 13 31.8) 7.6% 1.8 13.4) treatment. median 13.2 months 10.1 16.2) 9.7 7.5 12) (hazard for death, 0.68; 95% 0.48 0.95). higher incidence grade 3 neutropenia (35 76 vs. 19 patients, P=0.004), thrombocytopenia (18 6 P=0.007), two treatment-related deaths (2.6%) none treatment.ConclusionsSequential significantly when treatment; this came greater toxicity. (Funded Celgene; EuCT number, 2014-005350-19; ClinicalTrials.gov NCT02504333.)