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Post-registration experience of nivolumab in advanced hepatocellular carcinoma: an international study
- Source :
- Journal for Immunotherapy of Cancer
- Publication Year :
- 2020
-
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.
- 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
Subjects
Details
- ISSN :
- 20511426
- Volume :
- 8
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Journal for immunotherapy of cancer
- Accession number :
- edsair.doi.dedup.....a8527677104abed8cb2f66cc6ea71ed9