Lenvatinib (LEN) has demonstrated the efficacy and safety in patients (pts) with advanced HCC (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.
This is a multicenter retrospective analysis from 3 Korean referral cancer institutions. Between September 2018 and November 2019, a total of 86 pts received LEN for the management of BCLC B or C aHCC, and 75 pts who had at least one follow-up visit after the start of LEN were included in this analysis.
Median age was 59 years (range, 19-81), and 56 pts (74.7%) were male. Baseline characteristics were as follows; Child-Pugh class A/B in 57 (76.0%)/18 (24.0%), BCLC B/C in 9 (12.0%)/66 (88.0%), prior systemic therapy in 24 (32.0%) including 14 (18.7%) with prior immune checkpoint inhibitors (ICIs). LEN was used as 1st/2nd/3rd-4th lines of therapy in 51 (68.0%)/13 (17.3%)/11 (14.7%) pts, and 30 (40.0%) had extensive disease extent excluded in the REFLECT trial. In overall pts, the median follow-up duration was 4.7 months (mo) (95% CI, 3.3-6.2), the median PFS and OS were 4.6 (95% CI, 3.6-5.6) and 6.7 mo (95% CI, 5.0-8.3), repectively. In Child-Pugh A group, the PFS and OS were as follows: 1st line setting, 4.6 (95% CI,3.1-6.1) and 10.7 mo (95% CI, 4.7-16.6); >= 2nd line setting, 4.4 (95% CI, 2.8-6.0) and 6.4 mo (95% CI,4.7-8.0); prior ICI group 4.4 (95% CI, 3.6-5.1) and 7.1 mo (95% CI, 5.7-8.5), respectively. In Child-Pugh B group, the PFS and OS were 2.6 (95% CI, 0.6-4.6) and 5.3 mo (95% CI, 2.0-8.5), respectively. According to the RECIST v 1.1, response rates and disease control rate were 10.7% and 77.4%, respectively, in overall pts. The most common grade 3-4 toxicities were hyperbilirubinemia (n=8, 10.7%), AST elevation (n=6, 8.0%) and diarrhea (n=4, 5.3%).
LEN was effective and well tolerated in pts with aHCC in Korean real-life setting.
The authors.
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C. Yoo: Advisory/Consultancy: Bayer; Advisory/Consultancy: Eisai; Advisory/Consultancy: Ipsen; Advisory/Consultancy: MSD. All other authors have declared no conflicts of interest.