한빛사논문
- 조회270
Stephen L. Chan a,b, Baek-Yeol Ryoo c, Frankie Mo b, Landon L. Chan b, Jaekyung Cheon c, Leung Li b, Kwan H. Wong b, Nicole Yim b, Hyeyeong Kim d, Changhoon Yoo c
aState Key Laboratory of Translational Oncology
bDepartment of Clinical Oncology, Sir YK Pao Centre for Cancer, Hong Kong Cancer Institute, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
cDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
dDivision of Hematology-Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
Corresponding authors: Stephen L. Chan, Changhoon Yoo
Abstract
Background and aims: There has been a lack of prospective data on treatment after immune checkpoint inhibitor (ICI) in hepatocellular carcinoma (HCC). We conducted a phase II multicentred study on cabozantinib in HCC after ICI treatment.
Methods: This is an investigator-initiated single-arm clinical trial involving academic centres in Hong Kong and Korea. Key eligibility criteria include diagnosis of HCC; refractoriness to prior ICI-based treatment; Child-Pugh A liver function. Maximally two prior lines of therapy were allowed. All patients were commenced cabozantinib at 60mg/day. The primary endpoint was progression-free survival (PFS).
Results: Total 47 patients were recruited from Oct 2020 to May 2022. The median follow-up was 11.2 months. In the study, 27 and 20 patients received one and two prior therapies. The median PFS was 4.1 months (95%CI:3.3-5.3). The median OS was 9.9 months (95%CI:7.3-14.4), and the 1-year OS rate was 45.3%. Partial response and stable disease occurred in 3 (6.4%) and 36 (76.6%) of patients. When used as a second-line treatment (n=20), cabozantinib was associated with a median PFS and OS of 4.3 (95%CI:3.3-6.7) and 14.3 months (95%CI:8.9-NR). The corresponding median PFS and OS was 4.3 (95%CI:3.3-11.0) and 14.3 months (95%CI:9.0-NR) for those receiving ICI-based regimen with proven benefits (n=17). Commonest grade 3-4 TRAE was thrombocytopenia (6.4%). The median dose of cabozantinib was 40mg/day. The number of prior therapy was an independent prognosticator (one vs. two; HR=0.37; p=0.03).
Conclusions: Cabozantinib demonstrates efficacy in patients with prior ICI. The survival data of second-line cabozantinib following the first-line ICI regimen provide reference for clinical trial testing post-ICI therapy. The number of prior line of treatment may be considered a stratification factor in randomized study.
Impact and implications: There is a lack of prospective data on systemic therapy following prior immune checkpoint inhibitors (ICIs) for hepatocellular carcinoma (HCC). The current phase II clinical trial reported the efficacy and safety data of cabozantinib in patients with prior ICI-based treatment. Exploratory analyses showed that the performance of cabozantinib differed significantly when used as second or third-line treatment. The above data could be used a reference for clinical practice and design of future clinical trials on subsequent treatment following ICIs.
논문정보
- Research article
- 2024년 04월 (BRIC 등록일 2024-04-08)
- 국내(교신)+국외 연구진
- 의약학 > 응용의학
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