Sistema de Salut de Catalunya
Institut Català de la Salut
[Lo Prinzi F] Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Italy. [Salani F] Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. [Rimini M] Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientifc Institute Hospital, Milan, Italy. [Rizzato MD] Department of Oncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. [Antonuzzo L] Clinical Oncology Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, University of Florence, Florence, Italy. Thoracic Surgery Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, University of Florence, Florence, Italy. [Camera S] Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientifc Institute Hospital, Milan, Italy. [Castet F] Gastrointestinal and Endocrine Tumor Unit, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-04-09T08:38:53Z
2025-04-09T08:38:53Z
2025-03
Advanced disease; Biliary tract cancer; Surgery
Malaltia avançada; Càncer de les vies biliars; Cirurgia
Enfermedad avanzada; Cáncer de las vías biliares; Cirugía
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.
Article
Published version
English
Quimioteràpia combinada; Tracte biliar - Càncer - Tractament; Tracte biliar - Càncer - Cirurgia; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols; DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Biliary Tract Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Biliary Tract Neoplasms; Other subheadings::Other subheadings::Other subheadings::/surgery; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias del tracto biliar; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias del tracto biliar; Otros calificadores::Otros calificadores::Otros calificadores::/cirugía
Oxford University Press
The Oncologist;30(3)
https://doi.org/10.1093/oncolo/oyae256
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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