Division of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
Jaekyung Cheon , Changhoon Yoo , Yeonghak Bang , Hong Jae Chon , Baek-Yeol Ryoo
Background: LEN has demonstrated the efficacy and safety in pts with aHCC as first-line treatment in the pivotal REFLECT trial. Further evaluation in real-world setting is necessary to measure the clinical outcomes of LEN in daily practice. Methods: This is a multicenter retrospective analysis from 3 Korean referral cancer institutions. Between September 2018 and August 2019, a total of 74 pts received LEN for the management of BCLC B or C aHCC, and 66 pts who had at least one follow-up visit after the start of LEN were included in this analysis. Results: Median age was 58 years (range, 19-81), and 46 pts (69.7%) were male. Baseline characteristics were as follows; Child-Pugh class A/B/C in 46 (69.7%)/14 (21.2%)/6 (9.1%), BCLC B/C/D in 1 (1.5%)/63 (95.5%)/2 (3.0%), prior systemic therapy in 25 (37.9%) including 14 (21.2%) with prior immune checkpoint inhibitors (ICIs). LEN was used as first/second/third to fourth lines of therapy in 41 (62.1%)/13 (19.7%)/12 (18.2%) pts, and 27 (40.9%) had extensive disease extent excluded in the REFLECT trial. With a median follow-up duration of 4.8 months (95% CI, 3.4–6.1), the median PFS and OS were 4.6 (95% CI, 3.2-6.0) and 7.5 months (mo) (95% CI, 3.7–11.2), respectively, in overall pts: first-line setting, 4.2 (95% CI, 3.2-5.2) and 6.5 mo (95% CI, 5.0-8.1), respectively; ≥ second-line setting, 6.1 mo (95% CI, 3.6–8.5) and not reached, respectively. In pts with prior ICIs, median PFS was 6.1 mo (95% CI, 1.8-8.4) and median OS was not reached. According to the RECIST v 1.1, response rates and disease control rate were 12.1% and 71.2%, respectively, in overall pts. The most common grade 3-4 toxicities were hyperbilirubinemia (n=9, 13.6%), AST elevation (n=5, 7.6%), diarrhea (n=4, 6.1%) and fatigue (n=4, 6.1%). Conclusions: LEN was effective and well tolerated in pts with aHCC in Korean real-life setting.
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