1. Post-registration experience of nivolumab in advanced hepatocellular carcinoma: an international study
- Author
-
Uqba Khan, Sonal Paul, Petros Fessas, Yehia I. Abugabal, Sirish Dharmapuri, Anushi Bulumulle, Celina Ang, Yi Hsiang Huang, Tomi Jun, Francesca Benevento, Bo Yu, David Szafron, Ahmed Kaseb, David J. Pinato, Tiziana Pressiani, Lorenza Rimassa, Yinghong Wang, Neil Nimkar, Anwaar Saeed, Chieh Ju Lee, Thomas U. Marron, Mahvish Muzaffar, Nicola Personeni, Hannah Hildebrand, Dominik Bettinger, Abdul Rafeh Naqash, Musharraf Navaid, and Wellcome Trust
- Subjects
Male ,Cancer Research ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,medicine.medical_treatment ,Immunology ,Systemic therapy ,Gastroenterology ,programmed cell death 1 receptor ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Immunology and Allergy ,Humans ,Adverse effect ,Aged ,Retrospective Studies ,Pharmacology ,Clinical/Translational Cancer Immunotherapy ,liver neoplasms ,business.industry ,antibodies, neoplasm ,Immunotherapy ,Middle Aged ,medicine.disease ,3. Good health ,Clinical trial ,Nivolumab ,Oncology ,030220 oncology & carcinogenesis ,Hepatocellular carcinoma ,Toxicity ,Molecular Medicine ,030211 gastroenterology & hepatology ,Observational study ,Female ,immunotherapy ,business - Abstract
BackgroundNivolumab is Food and Drug Administration approved in sorafenib-experienced, advanced hepatocellular carcinoma (HCC). Post-registration data of treatment in a real-world setting is lacking.Patients and methodsWe performed an international, multicenter observational study to confirm safety and efficacy of nivolumab in 233 patients treated outside clinical trials from eight centers in North America, Europe and Asia.ResultsPatients received nivolumab for Barcelona Clinic Liver Cancer stage C (n=191, 92.0%) and Child-Pugh (CP) A (n=158, 67.8%) or B (n=75, 32.2%) HCC as first (n=85, 36.5%) or second to fourth systemic therapy line (n=148, 63.5%). Objective response rate (ORR) was 22.4% and disease control rate was 52.1%. Median overall survival (OS) was 12.2 months (95% CI 8.4 to 16.0) and median progression-free survival was 10.1 months (95% CI 6.1 to 14.2). Treatment-related adverse events of grade >2 occurred in 26 patients (11.2%). Efficacy and safety were similar across CP classes and therapy line. OS was shorter in CP-B than A (7.3 months vs 16.3 months, p=0.05). Achievement of an objective response predicted for improved OS (25.4 months vs 13.2 months, pConclusionsThis study confirms safety and efficacy of nivolumab in advanced HCC across various lines of therapy and degrees of liver dysfunction. Despite equal ORR and toxicity to nivolumab, patients with CP-B functional class have shorter survival than the patients with CP-A.
- Published
- 2020