顺铂-吉西他滨-德瓦鲁单抗对手术后早期与晚期疾病复发的晚期胆道癌患者的疗效：全球大量现实人口。
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.
发表日期：2024 Oct 19
作者：
Federica Lo Prinzi, Francesca Salani, Margherita Rimini, Mario Domenico Rizzato, Lorenzo Antonuzzo, Silvia Camera, Tomoyuki Satake, Hanne Vandeputte, Caterina Vivaldi, Tiziana Pressiani, Jessica Lucchetti, Jin Won Kim, Oluseyi Abidoye, Ilario Giovanni Rapposelli, Stefano Tamberi, Fabian Finkelmeier, Guido Giordano, Chiara Pircher, Hong Jae Chon, Chiara Braconi, Alessandro Pastorino, Florian Castet, Emiliano Tamburini, Changhoon Yoo, Alessandro Parisi, Anna Diana, Mario Scartozzi, Gerald W Prager, Antonio Avallone, Marta Schirripa, Il Hwan Kim, Lukas Perkhofer, Ester Oneda, Monica Verrico, Jorge Adeva, Stephen L Chan, Gian Paolo Spinelli, Nicola Personeni, Ingrid Garajova, Maria Grazia Rodriquenz, Silvana Leo, Cecilia Melo Alvim, Ricardo Roque, Lorenzo Fornaro, Antonio De Rosa, Daniele Lavacchi, Federico Rossari, Masafumi Ikeda, Jeroen Dekervel, Monica Niger, Rita Balsano, Giuseppe Tonini, Minsu Kang, Tanios Bekaii-Saab, Massimo Giuseppe Viola, Lucrezia Silvestro, Luca Esposito, Alessandra Boccaccino, Vera Himmelsbach, Matteo Landriscina, Selma Ahcene Djaballah, Valentina Zanuso, Gianluca Masi, Sara Lonardi, Lorenza Rimassa, Andrea Casadei-Gardini
来源：
Experimental Hematology & Oncology
摘要：
在 TOPAZ-1 中，胆道癌 (BTC) 和术后 6 个月内复发的患者被排除在外，即使这种事件在临床实践中经常观察到。我们的研究旨在评估顺铂-吉西他滨-durvalumab (CGD) 在这一人群中的疗效是否与 3 期试验中报告的疗效相当。研究队列包括接受原发性肿瘤手术、经历疾病复发的 BTC 患者手术后或辅助治疗结束并开始CGD后≤6个月或>6个月。主要目标是总生存期 (OS) 和无进展生存期 (PFS)。共有 178 名患者入组。早期和晚期复发组之间的 OS（23.4 个月 vs 未达到；HR 1.26；95% CI，0.67-2.37；P = .45）和 PFS [7.0 个月 vs 9.8 个月；HR 1.26；95% CI，0.67-2.37；P = .45] 没有观察到显着差异。 HR 1.3（95% CI，0.9-2.1）P = .13]。总体安全性一样，两组的总体缓解率和疾病控制率（P = .33 和 P = .62）相当。此外，我们比较了选定人群和接受顺铂-吉西他滨 (CG) 治疗的 BTC 患者历史队列之间的生存结果，发现尽管没有统计学意义，但与 CG 相比，无论治疗时间如何，CGD 都显示出结果趋势。手术或辅助化疗后复发[(CG ≤ 6 vs CGD ≤ 6个月：HR 0.59，95%CI，0.35-1.01，P = .05；HR 0.70；95%CI，0.46-1.06，P = .09，OS和 PFS 分别）和（CG > 6 与 CGD > 6 个月：HR 0.50；95%CI，0.29-0.88，P = 0.0165；HR 0.54；95%CI，0.35-0.84，P = .0068，OS 和PFS）]。我们的分析表明，对于晚期 BTC 患者，CGD 保留其疗效，与手术后复发或完成辅助治疗的时间无关。© 作者 2024。由牛津大学出版社出版。
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.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).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)].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.© The Author(s) 2024. Published by Oxford University Press.