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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.

Authors :
Lo Prinzi F
Salani F
Rimini M
Rizzato MD
Antonuzzo L
Camera S
Satake T
Vandeputte H
Vivaldi C
Pressiani T
Lucchetti J
Kim JW
Abidoye O
Rapposelli IG
Tamberi S
Finkelmeier F
Giordano G
Pircher C
Chon HJ
Braconi C
Pastorino A
Castet F
Tamburini E
Yoo C
Parisi A
Diana A
Scartozzi M
Prager GW
Avallone A
Schirripa M
Kim IH
Perkhofer L
Oneda E
Verrico M
Adeva J
Chan SL
Spinelli GP
Personeni N
Garajova I
Rodriquenz MG
Leo S
Melo Alvim C
Roque R
Fornaro L
De Rosa A
Lavacchi D
Rossari F
Ikeda M
Dekervel J
Niger M
Balsano R
Tonini G
Kang M
Bekaii-Saab T
Viola MG
Silvestro L
Esposito L
Boccaccino A
Himmelsbach V
Landriscina M
Ahcene Djaballah S
Zanuso V
Masi G
Lonardi S
Rimassa L
Casadei-Gardini A
Source :
The oncologist [Oncologist] 2024 Oct 19. Date of Electronic Publication: 2024 Oct 19.
Publication Year :
2024
Publisher :
Ahead of Print

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.<br />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).<br />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)].<br />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.<br /> (© The Author(s) 2024. Published by Oxford University Press.)

Details

Language :
English
ISSN :
1549-490X
Database :
MEDLINE
Journal :
The oncologist
Publication Type :
Academic Journal
Accession number :
39427227
Full Text :
https://doi.org/10.1093/oncolo/oyae256