Citations 2
Negative impact of corticosteroid use on outcome in patients with advanced BTCs treated with cisplatin, gemcitabine, and durvalumab: A large real‐life worldwide population
Prinzi, Federica Lo , Salani, Francesca , Saborowski, Anna , Antonuzzo, Lorenzo , Rossari, Federico , Satake, Tomoyuki, Peeters, Frederik , Pressiani, Tiziana , Kim, Jin Won , Finkelmeier, Fabian , Chiara, Pircher, Chon, Hong Jae , Braconi, Chiara , Qaisar, Aitzaz, Pastorino, Alessandro , Castet, Florian , Parisi, Alessandro , Perkhofer, Lukas , Adeva, Jorge , Spinelli, Gian Paolo , Rodriquenz, Maria Grazia , Leo, Silvana, Alvim, Cecilia Melo, Polito, M.G. , Giacomo, Emanuela Di , Bartalini, L. , Grelli, Giada, Rosa, Antonio De, Lavacchi, Daniele, Ikeda, Masafumi, Dekervel, Jeroen , Balsano, Rita , Tesini, Giulia , Boccaccino, Alessandra , Himmelsbach, Vera, Vogel, Arndt, Rimassa, Lorenza , Casadei‐Gardini, Andrea, Vogel, Arndt , Casadei‐Gardini, Andrea , Rossari, Federico , Prager, Gerald W , Farinea, Giovanni , Niger, Monica , Rimini, Margherita , Antonuzzo, Lorenzo , Lo Prinzi, Federica , Parisi, Alessandro , Casadei-Gardini, Andrea , Finkelmeier, Fabian , Castet, Florian , Adeva, Jorge , Tesini, Giulia , Rimassa, Lorenza , Casadei-Gardini, Andrea , Saborowski, Anna , Pressiani, Tiziana , Jae Chon, Hong , Salani, Francesca , De Rosa, Antonio , Dekervel, Jeroen , Vogel, Arndt , Camera, Silvia , Lucchetti, Jessica , Abidoye, Oluseyi , Rapposelli, Ilario Giovanni , Gallio, Chiara , Tamberi, Stefano , Giordano, Guido , Chiara, Pircher, Tamburini, Emiliano , Yoo, Changhoon , Diana, Anna , Scartozzi, Mario , Prager, Gerald W. , Avallone, Antonio , Schirripa, Marta , Kim, Il Hwan , Oneda, Ester , Verrico, Monica , Couto, Nuno , Chan, Stephen L. , Personeni, Nicola , Garajova, Ingrid , Roque, Ricardo , Ikeda, Masafumi , Niger, Monica , Tonini, Giuseppe , Kang, Minsu , Landriscina, Matteo , Djaballah, Selma Ahcene , Bekaii‐Saab, Tanios , Fornaro, Lorenzo , Masi, Gianluca , Lonardi, Sara , Rimini, Margherita
International Journal of Cancer | July 11, 2025 | Volume: 157 | Issue: 10 | Pages: 2092-2102
Abstract In recent years, there has been increasing interest in the possible prognostic impact of concomitant medications in patients with cancer treated with immunotherapy combinations. This real‐world analysis aims to evaluate the impact of concomitant medications on survival outcomes in patients with advanced biliary tract cancer (BTCs) treated with cisplatin, gemcitabine and durvalumab (CGD) therapy. The study cohort included patients with a diagnosis of advanced BTCs who were taking concomitant medications for their comorbidities before the start of CGD. The primary objectives were overall survival (OS) and progression‐free survival (PFS). The initial population consisted of 666 patients, who were retrospectively collected from 41 sites in 12 countries. Data on concomitant medications were available for 493 patients. After a median follow‐up of 8.8 months (95% CI: 7.8–9.8), patients who did not take steroids (prednisone >10 mg/day or equivalent) or nonsteroidal anti‐inflammatory drugs (NSAIDs) and opioids, before the start of CGD, had longer OS and PFS in univariate analysis. The multivariate analysis confirmed longer OS for patients who did not take steroids. Patients who did not take steroids had an OS of 14.8 months (95% CI: 13.1–29.1) versus 5.0 months (95% CI: 2.14–11.32) of patients who took prednisone >10 mg/day or equivalent. No differences were reported in terms of overall response rate (ORR), disease control rate (DCR) ( p = 1.0 and p = .16, respectively), and safety profile between the two groups. Our analysis suggests that patients who did not receive steroids before the start of GCD had longer survival and highlighted the relevance of balancing concomitant medications and chemoimmunotherapy.
A Prognostic Index for Advanced Biliary Tract Cancer Treated With Cisplatin, Gemcitabine and Durvalumab: The MAGIC ‐D Index
Persano, Mara , Rimini, Margherita , Salani, Francesca , Prinzi, Federica Lo , Saborowski, Anna , Antonuzzo, Lorenzo , Passeri, Laura , Satake, Tomoyuki, Peeters, Frederik , Pressiani, Tiziana , Corallo, Salvatore , Finkelmeier, Fabian , Pircher, Chiara , Braconi, Chiara , Qaisar, Aitzaz, Pirrone, Chiara, Castet, Florian , Parisi, Alessandro , Scartozzi, Mario, Perkhofer, Lukas , Adeva, Jorge , Spinelli, Gian Paolo , Rodriquenz, Maria Grazia , Leo, Silvana, Alvim, Cecilia Melo, Roque, Ricardo , Rosa, Antonio De, Lanzetta, Irene, Balsano, Rita , Lavacchi, Daniele, Ikeda, Masafumi, Dekervel, Jeroen , Niger, Monica, Tesini, Giulia , Boccaccino, Alessandra , Himmelsbach, Vera, Vogel, Arndt, Rimassa, Lorenza , Casadei‐Gardini, Andrea, Vogel, Arndt , Casadei‐Gardini, Andrea , Kim, Jin Won , Abidoye, Oluseyi , Corallo, Salvatore , Rapposelli, Ilario Giovanni , Finkelmeier, Fabian , Pircher, Chiara , Pirrone, Chiara , Castet, Florian , Yoo, Changhoon , Oneda, Ester , Couto, Nuno , Adeva, Jorge , Tesini, Giulia , Djaballah, Selma Ahcene , Rimassa, Lorenza , Casadei-Gardini, Andrea , Antonuzzo, Lorenzo , Parisi, Alessandro , Casadei-Gardini, Andrea , Saborowski, Anna , Pressiani, Tiziana , Roque, Ricardo , Salani, Francesca , De Rosa, Antonio , Dekervel, Jeroen , Vogel, Arndt , Rimini, Margherita , Nichetti, Federico , Vivaldi, Caterina , Lucchetti, Jessica , Kim, Jin Won , Tamberi, Stefano , Giordano, Guido , Chon, Hong Jae , Tamburini, Emiliano , Diana, Anna , Scartozzi, Mario , Prager, Gerald W. , Avallone, Antonio , Schirripa, Marta , Kim, Il Hwan , Verrico, Monica , Chan, Stephen L. , Personeni, Nicola , Garajova, Ingrid , Farinea, Giovanni , Fornaro, Lorenzo , Camera, Silvia , Ikeda, Masafumi , Niger, Monica , Tonini, Giuseppe , Kang, Minsu , Bekaii‐Saab, Tanios , Esposito, Luca , Ferrara, Michele , Landriscina, Matteo , Masi, Gianluca , Lonardi, Sara
Liver International | June 17, 2025 | Volume: 45 | Issue: 7 | Pages: No page available
ABSTRACT Background Over the years, prognostic indexes have been developed to help clinicians stratify patients with biliary tract cancers (BTC) into risk groups. This study aims to identify a new prognostic index for patients with BTC treated with cisplatin, gemcitabine and durvalumab (CGD) in the first‐line setting. Patients and Methods The study population consisted of patients with BTC from 11 Eastern and Western Countries. Using multivariate analysis for overall survival (OS), we identified 5 baseline statistically significant variables: stage, carcinoembryonic antigen (CEA) levels, albumin levels, gamma glutamyl transferase (GGT) levels, neutrophil‐to‐lymphocyte ratio (NLR). Metastatic disease is a prognostic factor with a superior weight considering the HR of 3.62, while all the others can be considered prognostic factors with equivalent weight as the HRs are quite similar (HRs between 1.55 and 1.92). Based on these reasons, we developed a prognostic model called the MAGIC‐D index by assigning a score of 2 for metastatic disease, and a score of 1 for CEA increased levels, albumin decreased levels, GGT increased levels, NLR ≥ 3. Patients were stratified into three risk groups as follows: low‐risk group (Score from 0 to 2), intermediate‐risk group (Score from 3 to 4) and high‐risk group (Score from 5 to 6). At the first data cutoff (April 2024), these data were available for 319 patients that composed the training cohort used for the analysis. At the second data cutoff (May 2025), 79 patients were further enrolled and composed the validation cohort. Results Median progression‐free survival was 11.7 months in low‐risk group (20.7%), 8.7 months in intermediate‐risk group (46.4%) and 5.4 months in high‐risk group (32.9%) [low‐risk hazard ratio (HR): 0.27, intermediate‐risk HR: 0.55, high‐risk HR: 1, p < 0.0001]. Median OS was 18.4 months in low‐risk group,15.9 months in intermediate‐risk group and 7.8 months in high‐risk group (low‐risk HR: 0.17, intermediate‐risk HR: 0.43, high‐risk HR: 1, p < 0.0001). There was no difference in overall response rate (low‐risk: 31.8%, intermediate‐risk: 36.5% and high‐risk: 25.7%; p = 0.0718), while disease control rate was significantly different across the three risk groups (low‐risk: 83.3%, intermediate‐risk: 70.9% and high‐risk: 60.9%; p < 0.0001) as well as the rate of patients receiving a second‐line therapy (low‐risk: 54.5%, intermediate‐risk: 48.6% and high‐risk: 25.7%; p = 0.0061). Finally, the prognostic role in terms of OS and PFS of the MAGIC‐D index was confirmed in a validation cohort of 79 patients. Conclusion The MAGIC‐D index is an easy‐to‐use tool able to stratify patients with BTC with different prognoses undergoing first‐line therapy with CGD.