PMID- 31154669 OWN - NLM STAT- MEDLINE DCOM- 20200521 LR - 20200521 IS - 1097-0142 (Electronic) IS - 0008-543X (Linking) VI - 125 IP - 18 DP - 2019 Sep 15 TI - Nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis: Safety and clinical outcomes in a retrospective case series. PG - 3234-3241 LID - 10.1002/cncr.32206 [doi] AB - BACKGROUND: Nivolumab demonstrated durable responses and safety in patients with hepatocellular carcinoma (HCC) with Child-Pugh class A cirrhosis in the CheckMate 040 trial, with rates of hepatotoxicity that were similar to those of non-HCC populations. To the authors' knowledge, the safety and efficacy of nivolumab has not been established in patients with Child-Pugh class B (CPB) cirrhosis, a population with limited therapeutic options and a poor prognosis. METHODS: The authors conducted a retrospective case series of patients with advanced HCC and CPB cirrhosis who were treated with nivolumab and enrolled in the University of California at San Francisco Hepatobiliary Tissue Bank and Registry. Safety endpoints included rates of grade >/=3 adverse events (AEs) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.03]) and serious AEs, immune-related AEs (irAE), steroid requirement, and discontinuation. Efficacy endpoints included time on treatment, the objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, overall survival, and progression-free survival. RESULTS: A total of 18 patients were included, with 72% of them (13 of 18 patients) previously treated with sorafenib. The majority of patients (94%; 17 of 18 patients) experienced a grade >/=3 AE, with treatment-related grade >/=3 AEs reported in 28% of patients (5 of 18 patients). irAEs were reported to occur in approximately 50% of patients (9 of 18 patients), and 28% (5 of 18 patients) required steroids. Treatment-related AEs required discontinuation in 4 patients (22%). The median time on treatment was 2.3 months (95% CI, 1.9 months to upper bound not estimable). The objective response rate was 17% (3 of 18 patients), including 2 partial responses and 1 complete response. The median overall survival from the time of nivolumab initiation was 5.9 months (95% CI, 3 months to upper bound not estimable), with a median progression-free survival of 1.6 months (95% CI, 1.4-3.5 months). CONCLUSIONS: Patients with CPB HCC experienced high rates of AEs, although the frequency of irAEs was similar to that of patients with Child-Pugh class A HCC in the CheckMate 040 trial. A subset of patients experienced prolonged tumor responses. Nivolumab warrants further study in patients with CPB HCC. CI - (c) 2019 American Cancer Society. FAU - Kambhampati, Swetha AU - Kambhampati S AUID- ORCID: 0000-0002-4783-2643 AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Medical Center, San Francisco, California. AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California. FAU - Bauer, Kelly E AU - Bauer KE AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California. FAU - Bracci, Paige M AU - Bracci PM AD - Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, California. FAU - Keenan, Bridget P AU - Keenan BP AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Medical Center, San Francisco, California. AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California. FAU - Behr, Spencer C AU - Behr SC AD - Department of Radiology, University of California at San Francisco Medical Center, San Francisco, California. FAU - Gordan, John D AU - Gordan JD AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Medical Center, San Francisco, California. AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California. AD - Quantitative Biosciences Institute, University of California at San Francisco, San Francisco, California. FAU - Kelley, Robin K AU - Kelley RK AUID- ORCID: 0000-0002-1984-2430 AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Medical Center, San Francisco, California. AD - Division of Hematology and Oncology, Department of Medicine, University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California. LA - eng GR - Bili Project Foundation Inc/International PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190602 PL - United States TA - Cancer JT - Cancer JID - 0374236 RN - 0 (Antineoplastic Agents, Immunological) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents, Immunological/*therapeutic use MH - Carcinoma, Hepatocellular/complications/*drug therapy MH - Diarrhea/chemically induced MH - Drug Eruptions/etiology MH - Female MH - Humans MH - Liver Cirrhosis/*complications MH - Liver Neoplasms/complications/*drug therapy MH - Male MH - Middle Aged MH - Musculoskeletal Pain/chemically induced MH - Nivolumab/*therapeutic use MH - Progression-Free Survival MH - Pruritus/chemically induced MH - Retrospective Studies MH - Severity of Illness Index MH - Survival Rate OTO - NOTNLM OT - Child-Pugh class B cirrhosis OT - hepatic dysfunction OT - hepatocellular carcinoma (HCC) OT - immunotherapy OT - nivolumab EDAT- 2019/06/04 06:00 MHDA- 2020/05/22 06:00 CRDT- 2019/06/03 06:00 PHST- 2019/02/21 00:00 [received] PHST- 2019/04/10 00:00 [revised] PHST- 2019/04/28 00:00 [accepted] PHST- 2019/06/04 06:00 [pubmed] PHST- 2020/05/22 06:00 [medline] PHST- 2019/06/03 06:00 [entrez] AID - 10.1002/cncr.32206 [doi] PST - ppublish SO - Cancer. 2019 Sep 15;125(18):3234-3241. doi: 10.1002/cncr.32206. Epub 2019 Jun 2.