Abstract 171P
Background
HCC with PVTT portends a worse prognosis. This study compared the efficacy and safety of cTACE plus lenvatinib (cTACE+LEN) to the most commonly utilized regimen, cTACE plus sorafenib (cTACE+SOR), in patients with HCC and PVTT.
Methods
An open-label, single-center, prospective, randomized trial. Patients with previously untreated HCC complicated by type I-IV PVTT were randomized 1:1 to receive cTACE+LEN (LEN orally, 12 or 8 mg/d for bodyweight ≥60 or <60 kg) or cTACE+SOR (SOR orally, 400 mg BID). The primary endpoint was time to progression (TTP; time from randomization to disease progression), secondary endpoints included objective response rate (ORR), overall survival (OS) and toxicity. Tumor response was assessed using mRECIST. Prognostic factors were evaluated with a Cox regression analysis. SPSS v17.0 was used for all analyses.
Results
Between Dec 30, 2018 and May 31, 2020, 64 patients were randomized (cTACE+LEN, n=32; cTACE+SOR, n=32). Patients had a median age of 56 years, a male/female ratio of 13/3, the majority had type I/II PVTT (71.9%; n=46), 34.4% (n=22) had extrahepatic metastasis, and median tumor diameter was 9.0 cm (3.8−21.8). After a median follow-up of 12.5 months, patients in the cTACE+LEN group had a higher median TTP (4.7 vs 3.1 months, HR: 0.55 [95% CI: 0.32–0.97], P=0.037) and numerically higher ORR (50.0 vs 25.0%, P=0.07) and median OS (15.6 [95% CI: 7.7−23.5] vs 10.8 months [95% CI: 8.9−12.7], P=0.15) versus the cTACE+SOR group. A similar incidence of serious adverse events (n=4 vs 2, including gastrointestinal bleeding and hepatic failure), drug withdrawal and dose reduction occurred in the cTACE+LEN and cTACE+SOR groups, and no treatment-related deaths occurred during the study period. Objective response was identified as an independent predictor of favorable TTP (HR: 0.41 [95% CI: 0.22–0.75], P=0.004).
Conclusions
cTACE+LEN was safe, well-tolerated, and had favorable efficacy versus cTACE+SOR for the treatment of advanced HCC with PVTT and large tumor burden. Differences in ORR and OS did not reach statistical significance, which may be due to the limited sample size and requires further study.
Clinical trial identification
NCT04127396.
Editorial acknowledgement
Legal entity responsible for the study
Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Funding
Beijing Hospitals Authority, QML20191805.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
313P - Diagnostic value of micro RNA (miRNA) in renal cell cancer: A meta-analysis and systemic review
Presenter: Jestoni Aranilla
Session: e-Poster Display Session
314P - Comprehensive microbial signatures and genomic profiling in tumour samples using next generation sequencing
Presenter: Mei Qi Yee
Session: e-Poster Display Session
315P - High-penetrance breast and/or ovarian cancer susceptibility genes in Filipinos
Presenter: Frances Victoria Que
Session: e-Poster Display Session
316P - Implementation of Vela Analytics to accelerate comprehensive interpretation and reporting of next-generation sequencing-based oncology testing in clinical diagnostic laboratories
Presenter: Yingnan Yu
Session: e-Poster Display Session
317P - Genomic profiling and molecular pathology of Chinese glioma patients
Presenter: yuanli Zhao
Session: e-Poster Display Session
320P - Psychometric interplay of the perception of the real-life impact of COVID-19 pandemic: A cross-sectional survey of patients with newly diagnosed malignancies
Presenter: Kelvin Bao
Session: e-Poster Display Session
321P - Impact of COVID-19 and lockdown on adherence to treatment schedule among cancer patients
Presenter: Krishnamani Kalpathi
Session: e-Poster Display Session
322P - Challenged faced by cancer patients during the COVID-19 pandemic
Presenter: mithra Krishnamani
Session: e-Poster Display Session
323P - Oncology care in the Republic of Kazakhstan during COVID-19
Presenter: Dilyara Kaidarova
Session: e-Poster Display Session
324P - COVID era: Perception of oncologists from a developing nation
Presenter: Rakesh Roy
Session: e-Poster Display Session