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

2025-01-01

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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.