Efficacy and safety of nivolumab in patients with advanced hepatocellular carcinoma analyzed by patient age: A sub-analysis of the CheckMate 040 study.
Refereed conference paper presented and published in conference proceedings

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AbstractIntroduction: Patients with hepatocellular carcinoma (HCC) are often diagnosed at an advanced age and a large majority progress on current standard-of-care sorafenib therapy. The clinical benefit of systemic therapies in patients with HCC who are of advanced age is not well studied, although some prior reports suggest that efficacy and safety of sorafenib are not significantly affected by patient age (Di Costanzo et al, Med Oncol 2013). Here we report efficacy and safety of the programmed death-1 (PD-1) inhibitor nivolumab in age groups of patients with advanced HCC in the CheckMate 040 study (NCT01658878).

Methods: Patients aged > 18 yr who were sorafenib naive or sorafenib experienced received nivolumab 0.1–1.0 mg/kg (dose escalation) or 3 mg/kg (dose expansion) every 2 weeks irrespective of HCV/HBV infection or tumor-cell PD-1 ligand 1 (PD-L1) status. Primary endpoints were safety and tolerability (dose escalation) and objective response rate (ORR; dose expansion) using RECIST v1.1 by blinded independent central review (BICR).

Results: Overall, 262 patients were treated in the study; 80 patients (30.5%) were sorafenib naive and 182 (69.5%) were sorafenib experienced. Median age for all patients was 63.0 yr (range, 19–83); 142 (54.2%) were <65 yr, 89 (34.0%) were 65 yr to<75 yr, 120 (45.8%) were > 65 yr, and 31 (11.8%) were >75 yr. Median follow-up for this sub- analysis was 12.9 mo. Overall, ORRs (BICR) of 16.9% and 16.7% were achieved in patients< 65 yr and > 65 yr, respectively. In sorafenib-naive patients <65 yr and > 65 yr, ORRs were 21.1% (8/38) and 19.0% (8/42), respectively. In sorafenib - experienced patients <65 yr and > 65 yr, ORRs were 15.4% (16/104) and 15.4% (12/78), respectively. Grade 3/4 treatment-related AEs were reported in 19.7% (28/142) of all patients<65 yr and in 22.5% (27/120) of all patients >65 yr. Grade 3/4 treatment related ALT/AST elevations were reported in 2.8%–4.2% of patients <65 yr and in 3.3%–6.7% of patients > 65 yr. Additional baseline, efficacy, and safety data stratified by patient age groups will be presented.

Conclusion: In this sub-analysis, ORRs with nivolumab did not appear to be affected by patient age in patients with advanced HCC, and a manageable safety profile was observed across patient age groups.
All Author(s) ListMelero Ignacio, El-Khoueiry Anthony, Yau Thomas, Hsu Chiun, Kudo Masatoshi, Crocenzi Todd, Kim Tae-You, Choo Su-Pin, Trojan Jo¨ rg, Welling Theodore, Kang Yoon-Koo, Yeo Winnie, Chopra Akhil, Baakili Adyb, dela Cruz Christine, Zhao Huanyu, Sangro Bruno, Meyer Tim
Name of ConferenceESMO 19th World Congress on Gastrointestinal Cancer
Start Date of Conference28/06/2017
End Date of Conference01/07/2017
Place of ConferenceBarcelona
Country/Region of ConferenceSpain
Proceedings TitleAnnals of Oncology
Number in SeriesO-008
Volume Number28
Issue NumberSuppl 3
PublisherOxford University Press
LanguagesEnglish-United Kingdom
Keywordshepatocellular carcinoma, nivolumab

Last updated on 2021-14-09 at 00:57