Sonia Zaibet1, Vincent Hautefeuille2, Edouard Auclin3,4, Astrid Lièvre5, David Tougeron6, Mathieu Sarabi7, Marine Gilabert8, Julie Wasselin2, Julien Edeline9, Pascal Artru10, Dominique Bechade11, Clémence Morin7, Agnes Ducoulombier12, Julien Taieb1, Simon Pernot13. 1. Department of Hepato-Gastroenterology and Gastrointestinal Oncology, Hôpital Européen Georges Pompidou, Université de Paris, SIRIC CARPEM Comprehensive Cancer Center, Paris, France. 2. Department of Hepato-Gastroenterology and Gastrointestinal Oncology, CHU Amiens Picardie, Amiens, France. 3. Department of Medical Oncology, Hôpital Européen Georges Pompidou, Université de Paris, SIRIC CARPEM Comprehensive Cancer Center, Paris, France. 4. INSERM, UMR 1138, team 22, Centre de Recherche des Cordeliers, Université de Paris, Paris, France. 5. Department of Gastroenterology, CHU Rennes, INSERM U1242, Rennes, France. 6. Department of Hepato-Gastroenterology, CHU Poitiers, Poitiers, France. 7. Department of Medical Oncology, Centre Léon Bérard, Lyon, France. 8. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France. 9. Department of Medical Oncology, Centre Eugène Marquis, Rennes, France. 10. Department of Hepato-Gastroenterology, Hôpital Privé Jean Mermoz, Lyon, France. 11. Department of Medical Oncology, Institut Bergonié, Bordeaux, France. 12. Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France. 13. Department of Medical Oncology, Institut Bergonié, Bordeaux, France. simon.pernot@gmail.com.
Abstract
BACKGROUND: Gemcitabine (Gem) alone or with Nab-paclitaxel (Gem-Nab) is used as second-line treatment for metastatic pancreatic adenocarcinoma (mPA) after FOLFIRINOX (FFX) failure; however, no comparative data exist. This study evaluates the efficacy and safety of adding Nab-paclitaxel to Gem for mPA after FFX failure. METHODS: In this retrospective real-world multicenter study, from 2011 to 2019, patients with mPA receiving Gem-Nab (Gem 1000 mg/m² + Nab 125 mg/m², 3 out of 4 weeks) or Gem alone were included after progression on FFX. RESULTS: A total of 427 patients were included. Patients receiving Gem-Nab had more metastatic sites, peritoneal disease and less PS 2 (24% vs. 35%). After median follow-up of 22 months, Gem-Nab was associated with better disease control rate (DCR) (56% vs. 32%; P < 0.001), progression-free survival (PFS) (3.5 vs. 2.3 months; 95% CI: 0.43-0.65) and overall survival (OS) (7.1 vs. 4.7 months; 95% CI: 0.53-0.86). After multivariate analysis, Gem-Nab and PS 0/1 were associated with better OS and PFS. Grade 3/4 toxicity was more frequent with Gem-Nab (44% vs. 29%). CONCLUSION: In this study, Gem-Nab was associated with better DCR, PFS and OS compared with Gem alone in patients with mPA after FFX failure, at the cost of higher toxicity.
BACKGROUND: Gemcitabine (Gem) alone or with Nab-paclitaxel (Gem-Nab) is used as second-line treatment for metastatic pancreatic adenocarcinoma (mPA) after FOLFIRINOX (FFX) failure; however, no comparative data exist. This study evaluates the efficacy and safety of adding Nab-paclitaxel to Gem for mPA after FFX failure. METHODS: In this retrospective real-world multicenter study, from 2011 to 2019, patients with mPA receiving Gem-Nab (Gem 1000 mg/m² + Nab 125 mg/m², 3 out of 4 weeks) or Gem alone were included after progression on FFX. RESULTS: A total of 427 patients were included. Patients receiving Gem-Nab had more metastatic sites, peritoneal disease and less PS 2 (24% vs. 35%). After median follow-up of 22 months, Gem-Nab was associated with better disease control rate (DCR) (56% vs. 32%; P < 0.001), progression-free survival (PFS) (3.5 vs. 2.3 months; 95% CI: 0.43-0.65) and overall survival (OS) (7.1 vs. 4.7 months; 95% CI: 0.53-0.86). After multivariate analysis, Gem-Nab and PS 0/1 were associated with better OS and PFS. Grade 3/4 toxicity was more frequent with Gem-Nab (44% vs. 29%). CONCLUSION: In this study, Gem-Nab was associated with better DCR, PFS and OS compared with Gem alone in patients with mPA after FFX failure, at the cost of higher toxicity.
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