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. 2025 Mar 10;30(3):oyae256.
doi: 10.1093/oncolo/oyae256.

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

Federica Lo Prinzi  1 , Francesca Salani  2   3 , Margherita Rimini  4 , Mario Domenico Rizzato  5 , Lorenzo Antonuzzo  6   7 , Silvia Camera  4 , Tomoyuki Satake  8 , Hanne Vandeputte  9 , Caterina Vivaldi  2   3 , Tiziana Pressiani  10 , Jessica Lucchetti  1 , Jin Won Kim  11 , Oluseyi Abidoye  12 , Ilario Giovanni Rapposelli  13 , Stefano Tamberi  14 , Fabian Finkelmeier  15 , Guido Giordano  16   17 , Chiara Pircher  18 , Hong Jae Chon  19 , Chiara Braconi  20 , Alessandro Pastorino  21 , Florian Castet  22 , Emiliano Tamburini  23 , Changhoon Yoo  24 , Alessandro Parisi  25 , Anna Diana  26 , Mario Scartozzi  27 , Gerald W Prager  28 , Antonio Avallone  29 , Marta Schirripa  30 , Il Hwan Kim  31 , Lukas Perkhofer  32   33 , Ester Oneda  34 , Monica Verrico  35 , Jorge Adeva  36 , Stephen L Chan  37 , Gian Paolo Spinelli  38 , Nicola Personeni  39 , Ingrid Garajova  40 , Maria Grazia Rodriquenz  41 , Silvana Leo  42 , Cecilia Melo Alvim  43 , Ricardo Roque  44 , Lorenzo Fornaro  2 , Antonio De Rosa  5   45 , Daniele Lavacchi  6 , Federico Rossari  4 , Masafumi Ikeda  8 , Jeroen Dekervel  9 , Monica Niger  18 , Rita Balsano  10   46 , Giuseppe Tonini  47 , Minsu Kang  11 , Tanios Bekaii-Saab  12 , Massimo Giuseppe Viola  23 , Lucrezia Silvestro  29 , Luca Esposito  13 , Alessandra Boccaccino  14 , Vera Himmelsbach  15 , Matteo Landriscina  16   17 , Selma Ahcene Djaballah  5 , Valentina Zanuso  10   46 , Gianluca Masi  2   3 , Sara Lonardi  5 , Lorenza Rimassa  10   46 , Andrea Casadei-Gardini  4
Affiliations

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

Federica Lo Prinzi et al. Oncologist. .

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.

Keywords: advanced disease; biliary tract cancer; cholangiocarcinoma; durvalumab; immunotherapy; real-world evidence; surgery.

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Conflict of interest statement

LR reports grant/research funding (to institution) from Agios, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, IPSEN, Lilly, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, TransThera Sciences, and Zymeworks; consulting fees from AbbVie, AstraZeneca, Basilea, Bayer, Bristol Myers Squibb, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, IPSEN, IQVIA, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, and Zymeworks; lecture fees from AstraZeneca, Bayer, Bristol Myers Squibb, Guerbet, Incyte, IPSEN, Roche, and Servier; and travel expenses from AstraZeneca. SL Chan serves as an advisory member for AstraZeneca, MSD, Eisai, and Autem, received research funds from Celleron, Genorbio, Ipsen, MSD, Novartis, and SIRTEX, and honoraria from Astra-Zeneca, Bayer, BMS, Eisai, Hutchmed, Ipsen, MSD, and Roche. HJ Chon received honoraria from Eisai, Roche, ONO, MSD, Bristol Myers Squibb, BeiGene, Sanofi, Servier, AstraZeneca, Menarini, and Boryung, and received research grants from Roche, BeiGene, Dong-A ST, and Boryung Pharmaceuticals. CB received honoraria as speaker (AstraZeneca, Incyte) and consultant (Incyte, Servier, Boehringer Ingelheim, AstraZeneca, Jazz, Tahio), received research funds (Avacta, Medannex, Servier), and her spouse is an employee of AstraZeneca. RB lecture fees are from AstraZeneca, and travel expenses are from Roche. JA received consulting fees from AstraZeneca, Jazz Pharmaceuticals, MSD, Roche, Servier, Taiho Oncology, Zymeworks; lecture fees from AstraZeneca, Roche, Servier; travel expenses from AstraZeneca, Roche, Servier.

Figures

Figure 1.
Figure 1.
a: Kaplan-Meier curves of OS in patients with disease relapse ≤6 months after surgery/completion of adjuvant therapy and those with disease relapse >6 months after surgery/completion of adjuvant therapy. b: Kaplan-Meier curves of PFS in patients with disease relapse ≤6 months after surgery/completion of adjuvant therapy and those with disease relapse >6months after surgery/completion of adjuvant therapy.
Figure 2.
Figure 2.
Forest plot of OS and PFS in patients with disease relapse and treatment initiation [cisplatin-gemcitabine (CG) and cisplatin-gemcitabine-durvalumab (CGD)] ≤6 months after surgery/completion of adjuvant therapy, and OS and PFS in patients with disease relapse and treatment initiation [cisplatin-gemcitabine and cisplatin-gemcitabine-durvalumab) >6 months after surgery/completion of adjuvant therapy.
See this image and copyright information in PMC

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