Safety of nivolumab in combination with prior or concurrent radiation therapy in hepatocellular carcinoma

Abstract

Objectives Nivolumab has been demonstrated to be effective for the treatment of unresectable hepatocellular carcinoma (HCC). While many patients may additionally benefit from radiation therapy (RT), the toxicity of combination nivolumab and RT is unknown. Methods Patients who underwent liver-directed RT prior to or concurrent with nivolumab for HCC at our institution were reviewed. Toxicity was assessed by Common Terminology Criteria for Adverse Effects v5.0 criteria until disease progression, change in systemic therapy, additional liver-targeted locoregional therapy (LRT), or death. Prevalence ratios (PR) were compared for patients undergoing prior and concurrent RT. Childs-Turcotte-Pugh (CTP) and Albumin-Bilirubin (ALBI) scores at 1-, 3-, and 6-months were compared with baseline. ResultsWe identified 55 patients with median follow-up 6.0 months; 34 (62%) received prior and 21 (38%) received concurrent RT. Grade 3+ toxicity occurred in 8 patients (17%). Grade 3+ toxicities did not differ between prior and concurrent RT cohorts on the univariable analysis (

European Society of Organ Transplantation (ESOT) Consensus Report on Downstaging, Bridging and Immunotherapy in Liver Transplantation for Hepatocellular Carcinoma

“…Since no data was found on combined treatment with locoregional and immunotherapy in the setting of transplantation, data outside transplant setting was assessed. In this context, a total of 450 references were identified, whereas 14 were eventually included for further review (Supplementary Table S10) [105][106][107][108][109][110][111][112][113][114][115][116][117][118][119]. Two of these were systematic reviews and meta-analyses [105,106].…”

“…Finally, of the seven non-randomized retrospective studies, five focused on early-death or severe complications with none of the studies reporting any major complication or death associated with the treatment evaluated [108,[117][118][119][120]. In the remaining two retrospective studies safety was not reported [107,109]. Although these data provide valuable insight into the safety and long-term oncologic outcomes of combined treatments of locoregional therapy and immunotherapy in a non-transplant setting, they cannot be extrapolated to a transplant/waitlist-setting.…”