Citations 1
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
Prinzi, Federica Lo , Salani, Francesca , Antonuzzo, Lorenzo , Satake, Tomoyuki, Vandeputte, Hanne, Pressiani, Tiziana , Finkelmeier, Fabian , Pircher, Chiara , Braconi, Chiara , Pastorino, Alessandro , Castet, Florian , Parisi, Alessandro , Perkhofer, Lukas , Adeva, Jorge , Spinelli, Gian Paolo , Rodriquenz, Maria Grazia , Leo, Silvana, Alvim, Cecilia Melo, Roque, Ricardo , Rosa, Antonio De, Lavacchi, Daniele, Dekervel, Jeroen , Balsano, Rita , Viola, Massimo, Silvestro, Lucrezia , Boccaccino, Alessandra , Himmelsbach, Vera, Zanuso, Valentina , Rimassa, Lorenza , Casadei‐Gardini, Andrea , Lo Prinzi, Federica , Abidoye, Oluseyi , Parisi, Alessandro , Ikeda, Masafumi , Antonuzzo, Lorenzo , Casadei-Gardini, Andrea , Finkelmeier, Fabian , Castet, Florian , Adeva, Jorge , Rimassa, Lorenza , Casadei-Gardini, Andrea , Pressiani, Tiziana , Roque, Ricardo , Salani, Francesca , De Rosa, Antonio , Dekervel, Jeroen , Rimini, Margherita , Rizzato, Mario Domenico , Camera, Silvia , Vivaldi, Caterina , Lucchetti, Jessica , Kim, Jin Won , Rapposelli, Ilario Giovanni , Tamberi, Stefano , Giordano, Guido , Chon, Hong Jae , Tamburini, Emiliano , Yoo, Changhoon , Diana, Anna , Scartozzi, Mario , Prager, Gerald W. , Avallone, Antonio , Schirripa, Marta , Kim, Il Hwan , Oneda, Ester , Verrico, Monica , Chan, Stephen L. , Personeni, Nicola , Garajova, Ingrid , Fornaro, Lorenzo , Rossari, Federico , Ikeda, Masafumi , Niger, Monica , Tonini, Giuseppe , Kang, Minsu , Bekaii‐Saab, Tanios , Esposito, Luca , Landriscina, Matteo , Djaballah, Selma Ahcene , Masi, Gianluca , Lonardi, Sara
The Oncologist | September 6, 2024 | Volume: 30 | Issue: 3 | Pages: No page available
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.