Abdelkader Taibi1,2, Olivia Sgarbura3,4, Martin Hübner5, Sylvia M Bardet6, Mohammed Alyami7,8, Naoual Bakrin7, Sylvaine Durand Fontanier9,6, Clarisse Eveno10, Johan Gagniere11, Basile Pache5, Marc Pocard12,13, François Quenet3, Hugo Teixeira Farinha5, Emilie Thibaudeau14, Frederic Dumont14, Olivier Glehen7. 1. Digestive Surgery Department, Dupuytren Limoges University Hospital, Limoges, France. abdelkader.taibi@hotmail.Fr. 2. CNRS, XLIM, UMR 7252, University Limoges, Limoges, France. abdelkader.taibi@hotmail.Fr. 3. Department of Surgical Oncology, Cancer Institute Montpellier (ICM), University of Montpellier, Montpellier, France. 4. IRCM, Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Université de Montpellier, Institut régional du Cancer de Montpellier, Montpellier, France. 5. Department of Visceral Surgery, Lausanne University Hospital (CHUV), University of Lausanne (UNIL), Lausanne, Switzerland. 6. CNRS, XLIM, UMR 7252, University Limoges, Limoges, France. 7. Department of General Surgery and Surgical Oncology, Lyon Sud University Hospital, Pierre Benite, France. 8. Department of General Surgery and Surgical Oncology, King Khalid Hospital, Najran, Saudi Arabia. 9. Digestive Surgery Department, Dupuytren Limoges University Hospital, Limoges, France. 10. Department of General Surgery, University Hospital Lille, Lille, France. 11. Department of General Surgery, University Hospital Clermont-Ferrand, Clermont-Ferrand, France. 12. INSERM U1275, CAP Paris-Tech, Carcinomatosis Peritoneum Paris Technology, Lariboisière Hospital, AP-HP, Paris 7 -Diderot University, Sorbonne Paris Cité, Paris, France. 13. Hepato-Biliary-Pancreatic Gastrointestinal Surgery and Liver Transplantation Pitié-Salpêtrière Hospital Assistance Publique/Hôpitaux de Paris, 75013, Paris, France. 14. Department of Surgical Oncology, Institut de Cancérologie de l'Ouest, Saint Herblain, France.
Abstract
BACKGROUND: This retrospective multicenter cohort study compared the feasibility and safety of oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-Ox) with or without intraoperative intravenous 5-fluorouracil (5-FU) and leucovorin (L). METHODS: Our study included consecutive patients with histologically proven unresectable and isolated colorectal peritoneal metastases (cPM) treated with PIPAC-Ox in seven tertiary referral centers between January 2015 and April 2020. Toxicity events and oncological outcomes (histological response, progression-free survival, and overall survival) were compared between patients who received intraoperative intravenous 5-FU/L (PIPAC-Ox + 5-FU/L group) and patients who did not (PIPAC-Ox group). RESULTS: In total, 101 patients (263 procedures) were included in the PIPAC-Ox group and 30 patients (80 procedures) were included in the PIPAC-Ox + 5-FU/L group. Common Terminology Criteria for Adverse Events v4.0 grade 2 or higher adverse events occurred in 48 of 101 (47.5%) patients in the PIPAC-Ox group and in 13 of 30 (43.3%) patients in the PIPAC-Ox + 5-FU/L group (p = 0.73). The complete histological response rates according to the peritoneal regression grading score were 27% for the PIPAC-Ox + 5-FU/L group and 18% for the PIPAC-Ox group (p = 0.74). No statistically significant differences were observed in overall or progression-free survival between the two groups. CONCLUSIONS: The safety and feasibility of PIPAC-Ox + 5-FU/L appears to be similar to the safety and feasibility of PIPAC-Ox alone in patients with unresectable cPM. Oncological outcomes must be evaluated in larger studies.
BACKGROUND: This retrospective multicenter cohort study compared the feasibility and safety of oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-Ox) with or without intraoperative intravenous 5-fluorouracil (5-FU) and leucovorin (L). METHODS: Our study included consecutive patients with histologically proven unresectable and isolated colorectal peritoneal metastases (cPM) treated with PIPAC-Ox in seven tertiary referral centers between January 2015 and April 2020. Toxicity events and oncological outcomes (histological response, progression-free survival, and overall survival) were compared between patients who received intraoperative intravenous 5-FU/L (PIPAC-Ox + 5-FU/L group) and patients who did not (PIPAC-Ox group). RESULTS: In total, 101 patients (263 procedures) were included in the PIPAC-Ox group and 30 patients (80 procedures) were included in the PIPAC-Ox + 5-FU/L group. Common Terminology Criteria for Adverse Events v4.0 grade 2 or higher adverse events occurred in 48 of 101 (47.5%) patients in the PIPAC-Ox group and in 13 of 30 (43.3%) patients in the PIPAC-Ox + 5-FU/L group (p = 0.73). The complete histological response rates according to the peritoneal regression grading score were 27% for the PIPAC-Ox + 5-FU/L group and 18% for the PIPAC-Ox group (p = 0.74). No statistically significant differences were observed in overall or progression-free survival between the two groups. CONCLUSIONS: The safety and feasibility of PIPAC-Ox + 5-FU/L appears to be similar to the safety and feasibility of PIPAC-Ox alone in patients with unresectable cPM. Oncological outcomes must be evaluated in larger studies.
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