Viola, Massimo
Mayo Clinic
Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card. G. Panico"
Citations 2
Exploring the Role of Surgery After Systemic Therapy in Locally Advanced Biliary Tract Cancer: Outcomes From a Large Retrospective Multinational Real‐World Cohort Treated With Cisplatin, Gemcitabine, and Durvalumab
Rimini, Margherita , Lamarca, Angela, Ikeda, Masafumi, Kim, Jin Won , Vogel, Arndt, Peeters, Frederik , Pinato, David J., Pircher, Chiara, Martirena, A. , Perkhofer, Lukas , Pinto, C. , Kang, Beodeul, Pastorino, Alessandro , Changhoon, Yoo, Rodriquenz, Maria Grazia , Scartozzi, Mario, Zumstein, Lucrezia , Ghidini, Michele, Aprile, Giuseppe , Spinelli, Gian Paolo , Yung‐Yeh, Su, Bolnykh, Iakov, Lancianese, Alessia , Satake, Tomoyuki, Lavacchi, Daniele, Passeri, Laura , Kang, Minsu, Viola, Massimo, Persano, Mara , Balsano, Rita , Ratti, Francesca, Rimassa, Lorenza , Kim, Jin Won , Vivaldi, Caterina , Formica, Vincenzo , Farinea, Giovanni , Prager, Gerald W , Chan, Stephen L , Niger, Monica , Fornaro, Lorenzo , Casadei-Gardini, Andrea , Rimassa, Lorenza , Saborowski, Anna , Rimini, Margherita , Lamarca, Angela , Ikeda, Masafumi , Abidoye, Oluseyi , Lucchetti, Jessica , Antonuzzo, Lorenzo , Vogel, Arndt , Nichetti, Federico , Pressiani, Tiziana , Vivaldi, Caterina , Rapposelli, Ilario Giovanni , Braconi, Chiara , Pinato, David J. , Tamburini, Emiliano , Pircher, Chiara , Tamberi, Stefano , Castet, Florian , Verrico, Monica , Parisi, Alessandro , Couto, Nuno , Chon, Hong Jae , Landriscina, Matteo , Finkelmeier, Fabian , Oneda, Ester , Avallone, Antonio , Dell’Aquila, Emanuela , Kim, Il Hwan , Garajova, Ingrid , Kang, Beodeul , Corallo, Salvatore , Fenocchio, Elisabetta , Diana, Anna , Schirripa, Marta , Scartozzi, Mario , Ghidini, Michele , Prager, Gerald W. , Chan, Stephen L. , Bekaii‐Saab, Tanios , Ferrara, Michele , Kang, Minsu, Bozzarelli, Silvia , Masi, Gianluca , Niger, Monica , Lonardi, Sara , Salani, Francesca , Camera, Silvia , Ratti, Francesca , Fornaro, Lorenzo , Casadei‐Gardini, Andrea
International Journal of Cancer | July 29, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
ABSTRACT Surgery after response to first‐line chemoimmunotherapy may offer a potential curative option for patients with locally advanced biliary tract cancer (BTC) initially considered unresectable. However, robust real‐world evidence in this setting remains limited. We retrospectively analyzed patients with locally advanced BTC treated with first‐line cisplatin, gemcitabine, and durvalumab (CGD) across 55 centers in 12 countries. Endpoints included overall survival (OS), progression‐free survival (PFS), disease‐free survival (DFS) among resected patients, objective response rate (ORR), and the prognostic impact of surgery. A multivariable logistic regression model was developed to predict surgical conversion using baseline clinical and laboratory variables. Among 1358 screened patients, 219 had locally advanced disease and were included in the analysis. Median follow‐up was 14.5 months. ORR was 34.6%, with median PFS and OS of 10.0 and 20.7 months, respectively. Twenty‐four patients (10.9%) underwent surgical resection after systemic therapy. Median OS was 22.5 months in resected patients versus 19.9 months in those who did not undergo surgery. Median DFS after resection was 15.8 months. Pathological lymph node involvement was independently associated with shorter DFS. Larger baseline tumor size correlated with higher odds of radiological response but not with OS. An exploratory elastic‐net model retained four baseline variables and showed moderate discriminative ability for surgical conversion, with an apparent AUC of 0.72 and an optimism‐corrected AUC of 0.65. First‐line CGD enabled secondary resection in approximately 11% of patients with locally advanced BTC. A simple baseline model may support patient selection for conversion surgery, although prospective validation is needed.
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.