Background In the TOPAZ-1, patients with biliary tract cancers (BTC) and recurrence within 6 months after surgery were excluded, even if this event is frequently observed in clinical practice. Our study aimed to assess if the efficacy of cisplatin-gemcitabine-durvalumab (CGD) in this population is comparable to that reported in the phase 3 trial. Methods The study cohort included patients with BTC who underwent surgery on the primary tumor, experienced disease recurrence occurring <= 6 months or >6 months after surgery or after the end of adjuvant therapy and started CGD. The primary objectives were overall survival (OS) and progression free survival (PFS). Results A total of 178 patients were enrolled. No significant differences were observed between early and late relapse groups in OS (23.4 months vs not reached; HR 1.26; 95% CI, 0.67-2.37; P = .45) and PFS [7.0 months vs 9.8 months; HR 1.3(95% CI, 0.9-2.1) P = .13]. Overall response rate and disease control rate (P = .33 and P = .62) were comparable between the 2 groups, as the overall safety profile. In addition, we compared survival outcomes between the selected population and a historical cohort of patients with BTC treated with cisplatin-gemcitabine (CG) and found that despite the absence of statistical significance, CGD showed an outcome trend compared with CG regardless of the time of recurrence after surgery or adjuvant chemotherapy [(CG <= 6 vs CGD <= 6 months: HR 0.59, 95%CI, 0.35-1.01, P = .05; HR 0.70; 95%CI, 0.46-1.06, P = .09, OS and PFS, respectively) and (CG > 6 vs. CGD > 6 months: HR 0.50; 95%CI, 0.29-0.88, P = 0.0165; HR 0.54; 95%CI, 0.35-0.84, P = .0068, OS and PFS, respectively)]. Conclusion Our analysis suggests that CGD retains its efficacy independently of the timing of relapse after surgery or completion of adjuvant treatment in patients with advanced BTC.
Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population / Lo Prinzi, Federica; Salani, Francesca; Rimini, Margherita; Rizzato, Mario Domenico; Antonuzzo, Lorenzo; Camera, Silvia; Satake, Tomoyuki; Vandeputte, Hanne; Vivaldi, Caterina; Pressiani, Tiziana; Lucchetti, Jessica; Kim, Jin Won; Abidoye, Oluseyi; Rapposelli, Ilario Giovanni; Tamberi, Stefano; Finkelmeier, Fabian; Giordano, Guido; Pircher, Chiara; Chon, Hong Jae; Braconi, Chiara; Pastorino, Alessandro; Castet, Florian; Tamburini, Emiliano; Yoo, Changhoon; Parisi, Alessandro; Diana, Anna; Scartozzi, Mario; Prager, Gerald W; Avallone, Antonio; Schirripa, Marta; Kim, Il Hwan; Perkhofer, Lukas; Oneda, Ester; Verrico, Monica; Adeva, Jorge; Chan, Stephen L; Spinelli, Gian Paolo; Personeni, Nicola; Garajova, Ingrid; Rodriquenz, Maria Grazia; Leo, Silvana; Melo Alvim, Cecilia; Roque, Ricardo; Fornaro, Lorenzo; De Rosa, Antonio; Lavacchi, Daniele; Rossari, Federico; Ikeda, Masafumi; Dekervel, Jeroen; Niger, Monica; Balsano, Rita; Tonini, Giuseppe; Kang, Minsu; Bekaii-Saab, Tanios; Viola, Massimo Giuseppe; Silvestro, Lucrezia; Esposito, Luca; Boccaccino, Alessandra; Himmelsbach, Vera; Landriscina, Matteo; Ahcene Djaballah, Selma; Zanuso, Valentina; Masi, Gianluca; Lonardi, Sara; Rimassa, Lorenza; Casadei-Gardini, Andrea. - In: THE ONCOLOGIST. - ISSN 1083-7159. - ELETTRONICO. - (2024), pp. 1-10. [10.1093/oncolo/oyae256]
Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population
Antonuzzo, Lorenzo;Lavacchi, Daniele;
2024
Abstract
Background In the TOPAZ-1, patients with biliary tract cancers (BTC) and recurrence within 6 months after surgery were excluded, even if this event is frequently observed in clinical practice. Our study aimed to assess if the efficacy of cisplatin-gemcitabine-durvalumab (CGD) in this population is comparable to that reported in the phase 3 trial. Methods The study cohort included patients with BTC who underwent surgery on the primary tumor, experienced disease recurrence occurring <= 6 months or >6 months after surgery or after the end of adjuvant therapy and started CGD. The primary objectives were overall survival (OS) and progression free survival (PFS). Results A total of 178 patients were enrolled. No significant differences were observed between early and late relapse groups in OS (23.4 months vs not reached; HR 1.26; 95% CI, 0.67-2.37; P = .45) and PFS [7.0 months vs 9.8 months; HR 1.3(95% CI, 0.9-2.1) P = .13]. Overall response rate and disease control rate (P = .33 and P = .62) were comparable between the 2 groups, as the overall safety profile. In addition, we compared survival outcomes between the selected population and a historical cohort of patients with BTC treated with cisplatin-gemcitabine (CG) and found that despite the absence of statistical significance, CGD showed an outcome trend compared with CG regardless of the time of recurrence after surgery or adjuvant chemotherapy [(CG <= 6 vs CGD <= 6 months: HR 0.59, 95%CI, 0.35-1.01, P = .05; HR 0.70; 95%CI, 0.46-1.06, P = .09, OS and PFS, respectively) and (CG > 6 vs. CGD > 6 months: HR 0.50; 95%CI, 0.29-0.88, P = 0.0165; HR 0.54; 95%CI, 0.35-0.84, P = .0068, OS and PFS, respectively)]. Conclusion Our analysis suggests that CGD retains its efficacy independently of the timing of relapse after surgery or completion of adjuvant treatment in patients with advanced BTC.
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