Abstract 165P
Background
Lenvatinib is a new first-line molecular target drug for hepatocellular carcinoma (HCC) that is available worldwide. We evaluated the efficacy and safety of lenvatinib for unresectable HCC.
Methods
This study population included thirty-seven patients that we could follow from 42 patients who received lenvatinib between April 2018 and May 2019 in our hospital. We evaluated the lenvatinib treatment profile, the clinical response (according to mRECIST), adverse events (according to CTCAE v.4.0), progression free survival (PFS), overall survival (OS), conversion therapy and the tumor response after progressive disease (PD) and serious adverse events (sAEs).
Results
The study population included 34 male patients (91.9%). Eleven patients were positive for HBV, 14 were positive for HCV, 6 had a history of alcohol intake. The Child Pugh scores (CPS) were as follows: 5 (n = 27), 6 (n = 7), 7(n = 3). Fifteen patients had BCLC stage B and 22 had C. The reasons for lenvatinib included TACE failure/refractoriness (35.3%), vascular invasion (32%), extrahepatic spread: (27.0%), PD after other molecular target therapies (16.2%) . The initial dose was 12 mg (90%) in patients with a body weight of > 60 kg, 8 mg (68.8%) in patients with a body weight of < 60 kg; in these two groups, 50.0% and 66.6% of patients received a half-dose reduction after one month. The tumor responses were classified as follows: objective response rate (ORR), 35.1%; disease control rate (DCR), 70.3%; PFS, 7.3 months (95% CI 4.9-11.2); OS, the median OS was not reached. There was no significant differences in the CPS between before and after therapy (p = 0.68). The rates of AEs (any grade/grade ≥3) were as follows: hypertension (37.8/0%), protein urea (29.7/13.5%), hypothyroidism (16.2/0%), fatigue (8.1/2.7%), hand-foot skin reaction (5.4/0%), hepatic encephalopathy (8.1%), respectively. The ORR and DCR of the grade ≥3 and grade <2 groups did not differ to a statistically significant extent. In the grade ≥3 group, 4 patients obtained a clinical benefit, however could not receive chemotherapies because of a poor performance status (≥3).
Conclusions
Lenvatinib is good therapeutic drug for advanced HCC, however it is very important to pay attention to sAEs in patients who show a clinical benefit.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
87P - Negative to positive lymph node ratio-prognostic marker of survival in node positive rectal cancer
Presenter: Pavan Jonnada
Session: Poster display session
Resources:
Abstract
88P - The Sidra LUMC advanced colon cancer NGS cohort
Presenter: Wouter Hendrickx
Session: Poster display session
Resources:
Abstract
89P - A phase II trial of adjuvant chemoradiotherapy for patients with high-risk rectal submucosal invasive cancer after local resection
Presenter: Masaaki Noguchi
Session: Poster display session
Resources:
Abstract
90P - High MICB expression confers prognostic benefit in colorectal cancer
Presenter: Shanchao Yu
Session: Poster display session
Resources:
Abstract
91P - Adjuvant therapy for high-risk stage II or stage III colon adenocarcinoma: A propensity score-matched, nationwide, population-based cohort study
Presenter: Chien-Hsin Chen
Session: Poster display session
Resources:
Abstract
92P - Prospective randomized controlled study comparing primary surgery versus neoadjuvant chemotherapy followed by surgery in gastric carcinoma
Presenter: Vipin Goel
Session: Poster display session
Resources:
Abstract
93P - Biomarker selection of liver metastatic colorectal patients for anti-EGFR monoclonal antibodies: A machine learning analysis
Presenter: Yijiao Chen
Session: Poster display session
Resources:
Abstract
94P - NORTH/HGCSG1003: North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer: Final analysis
Presenter: Michio Nakamura
Session: Poster display session
Resources:
Abstract
95P - Anatomical resections improve relapse-free survival in patients with KRAS/NRAS/BRAF- mutated colorectal liver metastases
Presenter: Ye Wei
Session: Poster display session
Resources:
Abstract
96P - Incidence, characteristics and prognosis in colorectal cancer with CNS metastases
Presenter: Nicola Taylor
Session: Poster display session
Resources:
Abstract