Julien Edeline1, Meher Benabdelghani2, Aurélie Bertaut3, Jérôme Watelet4, Pascal Hammel5, Jean-Paul Joly6, Karim Boudjema7, Laetitia Fartoux8, Karine Bouhier-Leporrier9, Jean-Louis Jouve10, Roger Faroux11, Véronique Guerin-Meyer12, Jean-Emmanuel Kurtz13, Eric Assénat14, Jean-François Seitz15, Isabelle Baumgaertner16, David Tougeron17, Christelle de la Fouchardière18, Catherine Lombard-Bohas19, Eveline Boucher20, Trevor Stanbury21, Christophe Louvet22, David Malka23, Jean-Marc Phelip24. 1. 1 Centre Eugène Marquis, Rennes, France. 2. 2 Centre Paul Strauss, Strasbourg, France. 3. 3 Centre Georges-François Leclerc, Dijon, France. 4. 4 Centre Hospitalier Universitaire Brabois, Vondoeuvre les Nancy, France. 5. 5 Assistance Publique-Hôpital de Paris Hôpital Beaujon, Clichy, France. 6. 6 Centre Hospitalier Universitaire Nord, Amiens, France. 7. 7 Centre Hospitalier Universitaire Pontchaillou, Rennes, France. 8. 8 Assistance Publique-Hôpital de Paris Hôpital Saint-Antoine, Paris, France. 9. 9 Centre Hospitalier Universitaire Côte de Nacre, Caen, France. 10. 10 Hôpital Bocage, Dijon, France. 11. 11 Centre Hospitalier Universitaire Vendée, La Roche sur Yon, France. 12. 12 Institut de Cancérologie de l'Ouest Paul Papin, Angers, France. 13. 13 Centre Hospitalier Universitaire Hautepierre, Strasbourg, France. 14. 14 Centre Hospitalier Universitaire St Eloi, Montpellier, France. 15. 15 Centre Hospitalier Universitaire La Timone, Marseille, France. 16. 16 Assistance Publique-Hôpital de Paris Henri Mondor, Créteil, France. 17. 17 Centre Hospitalier Universitaire Poitiers, Poitiers, France. 18. 18 Centre Léon Bérard, Lyon, France. 19. 19 Centre Hospitalier Universitaire Edouard Herriot, Lyon, France. 20. 20 Centre Eugène Marquis, Rennes, France. 21. 21 Unicancer, Paris, France. 22. 22 Institut Mutualiste Montsouris, Paris, France. 23. 23 Gustave Roussy, Villejuif, France. 24. 24 Centre Hospitalier Universitaire St Etienne, St Etienne, France.
Abstract
PURPOSE: No standard adjuvant treatment currently is recommended in localized biliary tract cancer (BTC) after surgical resection. We aimed to assess whether gemcitabine and oxaliplatin chemotherapy (GEMOX) would increase relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who undergo resection. PATIENTS AND METHODS: We performed a multicenter, open-label, randomized phase III trial in 33 centers. Patients were randomly assigned (1:1) within 3 months after R0 or R1 resection of a localized BTC to receive either GEMOX (gemcitabine 1,000 mg/m2 on day 1 and oxaliplatin 85 mg/m2 infused on day 2 of a 2-week cycle) for 12 cycles (experimental arm A) or surveillance (standard arm B). Primary end points were RFS and HRQOL. RESULTS:Between July 2009 and February 2014, 196 patients were included. Baseline characteristics were balanced between the two arms. After a median follow-up of 46.5 months (95% CI, 42.6 to 49.3 months), 126 RFS events and 82 deaths were recorded. There was no significant difference in RFS between the two arms (median, 30.4 months in arm A v 18.5 months in arm B; hazard ratio [HR], 0.88; 95% CI, 0.62 to 1.25; P = .48). There was no difference in time to definitive deterioration of global HRQOL (median, 31.8 months in arm A v 32.1 months in arm B; HR, 1.28; 95% CI, 0.73 to 2.26; log-rank P = .39). Overall survival was not different (median, 75.8 months in arm A v 50.8 months in arm B; HR, 1.08; 95% CI, 0.70 to 1.66; log-rank P = .74). Maximal adverse events were grade 3 in 62% (arm A) versus 18% (arm B) and grade 4 in 11% versus 3% ( P < .001). CONCLUSION: There was no benefit of adjuvant GEMOX in resected BTC despite adequate tolerance and delivery of the regimen.
RCT Entities:
PURPOSE: No standard adjuvant treatment currently is recommended in localized biliary tract cancer (BTC) after surgical resection. We aimed to assess whether gemcitabine and oxaliplatin chemotherapy (GEMOX) would increase relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who undergo resection. PATIENTS AND METHODS: We performed a multicenter, open-label, randomized phase III trial in 33 centers. Patients were randomly assigned (1:1) within 3 months after R0 or R1 resection of a localized BTC to receive either GEMOX (gemcitabine 1,000 mg/m2 on day 1 and oxaliplatin 85 mg/m2 infused on day 2 of a 2-week cycle) for 12 cycles (experimental arm A) or surveillance (standard arm B). Primary end points were RFS and HRQOL. RESULTS: Between July 2009 and February 2014, 196 patients were included. Baseline characteristics were balanced between the two arms. After a median follow-up of 46.5 months (95% CI, 42.6 to 49.3 months), 126 RFS events and 82 deaths were recorded. There was no significant difference in RFS between the two arms (median, 30.4 months in arm A v 18.5 months in arm B; hazard ratio [HR], 0.88; 95% CI, 0.62 to 1.25; P = .48). There was no difference in time to definitive deterioration of global HRQOL (median, 31.8 months in arm A v 32.1 months in arm B; HR, 1.28; 95% CI, 0.73 to 2.26; log-rank P = .39). Overall survival was not different (median, 75.8 months in arm A v 50.8 months in arm B; HR, 1.08; 95% CI, 0.70 to 1.66; log-rank P = .74). Maximal adverse events were grade 3 in 62% (arm A) versus 18% (arm B) and grade 4 in 11% versus 3% ( P < .001). CONCLUSION: There was no benefit of adjuvant GEMOX in resected BTC despite adequate tolerance and delivery of the regimen.
Authors: Jesus M Banales; Jose J G Marin; Angela Lamarca; Pedro M Rodrigues; Shahid A Khan; Lewis R Roberts; Vincenzo Cardinale; Guido Carpino; Jesper B Andersen; Chiara Braconi; Diego F Calvisi; Maria J Perugorria; Luca Fabris; Luke Boulter; Rocio I R Macias; Eugenio Gaudio; Domenico Alvaro; Sergio A Gradilone; Mario Strazzabosco; Marco Marzioni; Cédric Coulouarn; Laura Fouassier; Chiara Raggi; Pietro Invernizzi; Joachim C Mertens; Anja Moncsek; Sumera Rizvi; Julie Heimbach; Bas Groot Koerkamp; Jordi Bruix; Alejandro Forner; John Bridgewater; Juan W Valle; Gregory J Gores Journal: Nat Rev Gastroenterol Hepatol Date: 2020-06-30 Impact factor: 46.802
Authors: Gilbert Murimwa; Caitlin Hester; John C Mansour; Patricio M Polanco; Matthew R Porembka; Sam C Wang; Herbert J Zeh; Adam C Yopp Journal: J Gastrointest Surg Date: 2020-07-23 Impact factor: 3.452
Authors: Mohammad Y Zaidi; Ghassan K Abou-Alfa; Cecilia G Ethun; Shailesh V Shrikhande; Mahesh Goel; Bruno Nervi; John Primrose; Juan W Valle; Shishir K Maithel Journal: Chin Clin Oncol Date: 2019-08-05
Authors: Ariella M Altman; Scott Kizy; Schelomo Marmor; Jane Y C Hui; Todd M Tuttle; Eric H Jensen; Jason W Denbo Journal: Hepatobiliary Surg Nutr Date: 2020-10 Impact factor: 7.293