Citations 2
Outcomes of Cisplatin, Gemcitabine, and Durvalumab According to TOPAZ ‐1 Study Eligibility: A Large Global Analysis in a Real‐World Setting
Prinzi, Federica Lo , Rimini, Margherita , Ikeda, Masafumi, Antonuzzo, Lorenzo, Kim, Jin Won, Pressiani, Tiziana, Peeters, Frederik , Pinato, David J., Pircher, Chiara, Tamberi, Stefano, Couto, Nuno, Chon, Hong Jae, Martirena, A. , Lamarca, Angela, Perkhofer, Lukas , Kim, Il Hwan, 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, Warmington, Emily , Lancianese, Alessia , Satake, Tomoyuki, Bekaii‐Saab, Tanios, Lavacchi, Daniele, Passeri, Laura , Kang, Minsu, Prete, Alessandra Anna, Bozzarelli, Silvia, Persano, Mara , Masi, Gianluca, Balsano, Rita , Lonardi, Sara, Salani, Francesca, Camera, Silvia, Vogel, Arndt, Rimassa, Lorenza, Rimassa, Lorenza , Vivaldi, Caterina , Farinea, Giovanni , Prager, Gerald W , Chan, Stephen L , Niger, Monica , Fornaro, Lorenzo , Casadei-Gardini, Andrea , Lo Prinzi, Federica , Rimassa, Lorenza , Saborowski, Anna , Rimini, Margherita , Ikeda, Masafumi , Abidoye, Oluseyi , Lucchetti, Jessica , Antonuzzo, Lorenzo , Kim, Jin Won , 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 , Lamarca, Angela , Landriscina, Matteo , Finkelmeier, Fabian , Oneda, Ester , Avallone, Antonio , Dell’Aquila, Emanuela , Kim, Il Hwan, Formica, Vincenzo , Garajova, Ingrid , Kang, Beodeul , Corallo, Salvatore , Fenocchio, Elisabetta , Diana, Anna , Schirripa, Marta , Scartozzi, Mario , Ghidini, Michele , Prager, Gerald W. , Chan, Stephen L. , Warmington, Emily, Satake, Tomoyuki , Bekaii‐Saab, Tanios , Giordano, Guido , Ferrara, Michele , Kang, Minsu, Prete, Alessandra Anna , Bozzarelli, Silvia , Masi, Gianluca , Niger, Monica , Lonardi, Sara , Salani, Francesca , Camera, Silvia , Vogel, Arndt , Fornaro, Lorenzo , Casadei‐Gardini, Andrea
International Journal of Cancer | August 12, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
ABSTRACT Many real‐world patients with advanced biliary tract cancer (BTC) are excluded by TOPAZ‐1 criteria; this study assessed cisplatin and gemcitabine plus durvalumab (CGD) efficacy and safety in these patients. Data from 1358 patients with advanced BTC treated with first‐line CGD across 55 international centers were retrospectively analyzed. Patients were classified as TOPAZ‐1‐in (meeting all inclusion criteria) or TOPAZ‐1‐out (meeting ≥ 1 exclusion criterion). Primary endpoints were overall survival (OS) and progression‐free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety. Furthermore, OS and PFS of the TOPAZ‐1‐out cohort were compared with reconstructed survival data from the phase III trial. 912 (67.1%) patients were classified as TOPAZ‐1‐in , and 446 (32.9%) as TOPAZ‐1‐out . After a median follow‐up of 14.5 months (95% CI: 13.7–36.5), OS was 16.1 months in TOPAZ‐1‐in and 12.5 months in TOPAZ‐1‐out (HR 0.69, 95% CI: 14.6–16.5, p = 0.0001); PFS was 8.2 versus 6.5 months (HR 0.73, 95% CI: 7.1–8.1, p < 0.0001). Median OS in the TOPAZ‐1‐out cohort (12.5 months) was nearly identical to the phase III trial experimental arm (12.9 months; HR 1.15, p = 0.13); for PFS the HR was 1.12 (95% CI 0.93–1.42; p = 0.09). Among TOPAZ‐1‐out patients, active infection, elevated bilirubin, and ECOG PS > 1 were linked to poorer OS, while no detrimental impact emerged for ALT/AST abnormalities, corticosteroid use, renal or hematologic parameters, or prior surgery within 6 months, suggesting treatment effectiveness was broadly maintained across clinical subgroups. Furthermore, TOPAZ‐1‐out patients experienced no significant increase in adverse events compared with the TOPAZ‐1‐in group. Real‐world data suggest CGD may be effective in TOPAZ‐1‐out patients, with no evident increase in toxicity, supporting the potential expanded use of the regimen in clinical practice.
EUS-guided hepaticogastrostomy versus single balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography for malignant biliary obstruction in patients with surgically altered anatomy
Igarashi, Tsuyoshi, Yamaguchi, Shota , Inoue, Kanae , Taira, Tomonao , Watanabe, Kazuo , Sasaki, Mitsuhito , Mitsunaga, Shuichi , Shibuki, Taro , Fukami, Norio , Satake, Tomoyuki , Imaoka, Hiroshi , Gotohda, Naoto , Ikeda, Masafumi
Endoscopic Ultrasound | July 4, 2025 | Volume: 14 | Issue: 4 | Pages: 196-204
ABSTRACT Background and objective Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for managing malignant biliary obstruction (MBO), but it is challenging in patients with surgically altered anatomy (SAA). EUS-guided hepaticogastrostomy (EUS-HGS) and enteroscopy-assisted ERCP are alternative techniques, but their comparative efficacy and safety in this population are not well-researched. Herein, we evaluated the outcomes of EUS-HGS versus single-balloon–assisted enteroscopy ERCP (SBE-ERCP) in MBO patients with SAA. Patients and methods This retrospective study included 70 patients with MBO who underwent EUS-HGS (n = 29) or SBE-ERCP (n = 41) at a single center between April 2015 and June 2024. Data on the patient characteristics, procedure details, time to recurrent biliary obstruction (TRBO), and adverse events (AEs) were analyzed. Results The EUS-HGS group showed a higher technical success rate (100% vs. 68%, P = 0.002), shorter procedure time (23 vs. 50 min, P < 0.001), and longer TRBO (251 vs. 103 d, P = 0.020) as compared with the SBE-ERCP group. Subgroup analysis revealed that pancreatobiliary cancer and SBE-ERCP were significantly associated with a shorter TRBO. When stratified by stent type, the median TRBO in the SBE-ERCP with PS group was 49 days, serving as the reference. In comparison, the median TRBO was 140 days in the SBE-ERCP with the self-expandable metallic stent group (hazard ratio [HR], 0.46; P = 0.181), 127 days in the EUS-HGS with PS group (HR, 0.38; P = 0.055), and 701 days in the EUS-HGS with the self-expandable metallic stent group (HR, 0.13; P = 0.014). The overall incidence of AEs was comparable between the 2 groups (20.6% vs. 17.1%), and there were no severe AEs. Regarding reintervention, there was no significant difference in technical success rate and procedure time between EUS-HGS and SBE-ERCP. Conclusion EUS-HGS was associated with a superior technical success rate, shorter procedure time, and longer stent patency, without an increased risk of AEs, as compared with SBE-ERCP. Thus, EUS-HGS should be appropriate for managing MBO patients with SAA.