Sorafenib for Advanced Hepatocellular Carcinoma: A Real-Life Experience

2018 ◽  
Vol 36 (5) ◽  
pp. 377-384 ◽  
Author(s):  
Larisse Longo ◽  
Laura Bainy Rodrigues de Freitas ◽  
Deivid Santos ◽  
Ivana Grivicich ◽  
Mário Reis Álvares-da-Silva
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Life Experience ◽  
Real Life ◽  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line ◽  
Second Line Therapy ◽  
Advanced Hcc ◽  
Line Therapy

Introduction: Sorafenib (SOR) has proved to be effective in patients with advanced hepatocellular carcinoma (HCC), since overall survival was higher in phase III clinical trials; however, disease progression can occur. Objectives: The study aimed to describe real-life experience in advanced HCC treatment with SOR at a university hospital in Brazil and to estimate the number of patients with indication of second-line therapy. Methods: This is a retrospective study that included cases of HCC with prescription of SOR based on real-life practice between 2011 and 2016. Demographic, clinical, and laboratory data were collected. Results: From 572 patients with HCC, SOR was prescribed in 103 cases. From them, 62.1% were classified as Child-Pugh (CP)-A, 54.4% as Barcelona Clinic Liver Cancer (BCLC)-C, and 74 (71.8%) started treatment. Overall survival was 25.5 (95% CI 17.0–34.1) months and 1-year survival was greater in patients who received SOR than in non-treated (88.7 vs. 44.4%, p < 0.001). There was no difference in survival between BCLC-B and C (p = 0.405), as well as CP-A and B (p = 0.919). In 21.6% of the patients, a second-line therapy with regorafenib was indicated. Conclusion: In this real-life study, SOR significantly increased the survival rate by 1 year in patients with advanced HCC regardless of BCLC staging and CP score. Second-line therapy would be indicated in 21.6% of cases.

Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline

2020 ◽  
Vol 38 (36) ◽  
pp. 4317-4345 ◽  
Author(s):  
John D. Gordan ◽  
Erin B. Kennedy ◽  
Ghassan K. Abou-Alfa ◽  
Muhammad Shaalan Beg ◽  
Steven T. Brower ◽  
...  
Keyword(s):  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Advanced Hcc ◽  
First Line Therapy ◽  
Line Therapy ◽  
First Line Treatment

PURPOSE To develop an evidence-based clinical practice guideline to assist in clinical decision making for patients with advanced hepatocellular carcinoma (HCC). METHODS ASCO convened an Expert Panel to conduct a systematic review of published phase III randomized controlled trials (2007-2020) on systemic therapy for advanced HCC and provide recommended care options for this patient population. RESULTS Nine phase III randomized controlled trials met the inclusion criteria. RECOMMENDATIONS Atezolizumab + bevacizumab (atezo + bev) may be offered as first-line treatment of most patients with advanced HCC, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1, and following management of esophageal varices, when present, according to institutional guidelines. Where there are contraindications to atezolizumab and/or bevacizumab, tyrosine kinase inhibitors sorafenib or lenvatinib may be offered as first-line treatment of patients with advanced HCC, Child-Pugh class A liver disease, and ECOG PS 0-1. Following first-line treatment with atezo + bev, and until better data are available, second-line therapy with a tyrosine kinase inhibitor may be recommended for appropriate candidates. Following first-line therapy with sorafenib or lenvatinib, second-line therapy options for appropriate candidates include cabozantinib, regorafenib for patients who previously tolerated sorafenib, or ramucirumab (for patients with α-fetoprotein ≥ 400 ng/mL), or atezo + bev where patients did not have access to this option as first-line therapy. Pembrolizumab or nivolumab are also reasonable options for appropriate patients following sorafenib or lenvatinib. Consideration of nivolumab + ipilimumab as an option for second-line therapy and third-line therapy is discussed. Further guidance on choosing between therapy options is included within the guideline. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .

The use of cabozantinib in advanced hepatocellular carcinoma (HCC): Hong Kong multi-center experience.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 316-316
Author(s):  
Yawen Dong ◽  
Thomas Wai-Tong Leung ◽  
Gin Wai Kwok ◽  
Vikki Tang ◽  
Bryan Li ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Hong Kong ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Objective Response ◽  
Real Life ◽  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Advanced Hcc

316 Background: In the phase III CELESTIAL trial, cabozantinib showed significant improvement in overall survival with good tolerability in advanced HCC population. We aimed to evaluate the efficacy, survival and tolerability of cabozatinib in advanced hepatocellular carcinoma (HCC) patients in a real life setting. Methods: Between February 2018 and October 2019, consecutive advanced HCC patients who received cabozatinib alone or in combination at University of Hong Kong Health System hospitals were analysed. Cabozantinib was administered at 60 mg continuously daily. Objective response rate (ORR), time-to-progression (TTP), overall survival (OS), and tolerability were evaluated. Results: Overall, 22 patients were included. The median age was 57.1 years (range 48.5-58.6). All patients except one were hepatitis B carriers. More than 80% of the patients had underlying Child-Pugh A cirrhosis. Most patients had metastatic disease (95.5%). More than 70% of patients received cabozantinib beyond second-line, and most of the patients had prior exposure to tyrosine kinase inhibitor (TKI) and/or immunotherapy. The median time from the start of first-line systemic treatment to the start of cabozantinib was 11.2 months. Cabozantinib was administered to 11 patients (50%) as single agent, while the other half received cabozantinib in combination with mostly immune checkpoint inhibitors. The median follow-up was 7.6 months. The table below shows the ORR. The overall median TTP and OS were 4.2 and 8.90 months, respectively. Interestingly, among those who received single agent cabozantinib, the median OS was 5.36 months in contrast to 12.32 months in the patients received combination. Overall, 90.9% of patients experienced treatment related adverse events (TRAEs) with transient liver function occurred in nearly 50% patients. Nevertheless, Grade 3/4 TRAEs was only 12%. Conclusions: Our present study showed that the use of cabozatinib in advanced HCC patients had good anti-tumour activity and survival benefits with acceptable toxicity profile. [Table: see text]

Eligibility for Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma

2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Erica S. Tsang ◽  
Janine M. Davies ◽  
Jonathan M. Loree ◽  
Howard J. Lim ◽  
Daniel J. Renouf ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

Phase III study of pembrolizumab (pembro) versus best supportive care (BSC) for second-line therapy in advanced hepatocellular carcinoma (aHCC): KEYNOTE-240 Asian subgroup.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 526-526 ◽  
Author(s):  
Masatoshi Kudo ◽  
Ho Yeong Lim ◽  
Ann-Lii Cheng ◽  
Yee Chao ◽  
Thomas Yau ◽  
...  
Keyword(s):  
Safety Data ◽  
Best Supportive Care ◽  
Geographic Region ◽  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line ◽  
Second Line Therapy ◽  
End Points ◽  
Significance Level ◽  
Line Therapy

526 Background: Pembro received accelerated approval for second-line therapy in aHCC based on KEYNOTE-224 (phase 2). KEYNOTE-240 (NCT02702401) is a randomized, phase 3 study of pembro v BSC in previously treated aHCC. We report outcomes for the Asian subgroup. Methods: Pts with a radiographic/pathologic HCC diagnosis, radiographic progression with/intolerance to sorafenib, Child-Pugh A disease, and ECOG PS 0/1 were randomized 2:1 to pembro (200 mg) + BSC or PBO + BSC Q3W (≤35 cycles or until confirmed PD/unacceptable toxicity). Pts were stratified by geographic region (Asia without Japan; non-Asia with Japan), AFP, and macrovascular invasion. Response was assessed Q6W (RECIST v1.1, central review). Primary end points: OS, PFS; secondary end points: ORR, DOR, safety. Data cutoff: Jan 2, 2019. Results: 413 pts were randomized (overall cohort: n = 278 pembro, n = 135 PBO; Asian subgroup [Hong Kong, Japan, Philippines, S Korea, Taiwan, Thailand]: n = 107, n = 50). HBV+ status and BCLC stage C were higher in Asian subgroup (HBV+: 51% v 24.5% overall; stage C: 86.6% v 79.4%). Median follow-up: pembro (21.3 mo overall; 23.5 mo); PBO (21.5 mo overall; 23.0 mo). Pembro improved OS v PBO (median OS [95% CI]: 13.9 [11.6-16.0] v 10.6 [8.3-13.5] mo; HR: 0.781; 95% CI, 0.611-0.998; P = 0.0238) and PFS (HR: 0.718; 0.570-0.904; P = 0.0022) for overall cohort and Asian subgroup (median OS: 13.8 [10.1-16.9] v 8.3 [6.3-11.8] mo; HR: 0.548; 0.374-0.804; P = 0.0009; PFS: HR: 0.475; 0.324-0.696; P < 0.0001). Differences did not meet prespecified significance level for overall cohort. ORR in overall cohort was 18.3% (14.0-23.4) for pembro; 4.4% (1.6-9.4; P = 0.00007) for PBO; in Asian subgroup, 20.6% (13.4-29.5) and 2.0% (0.1-10.6; P = 0.00135). Safety was consistent with that previously reported in pembro studies. No HBV/HCV flares were identified. Conclusions: Pembro reduced risk for death by 22% in overall cohort and 45% in Asian subgroup and improved PFS v PBO. Safety was comparable to that of pembro monotherapy. Results are consistent with KEYNOTE-224 and magnitude of OS benefit was enhanced in Asian subgroup, supporting a favorable risk-benefit balance for second-line pembro in HCC. Clinical trial information: NCT02702401.

scholarly journals Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: Multicentre, open-label, phase II safety study

2013 ◽  
Vol 49 (16) ◽  
pp. 3412-3419 ◽  
Author(s):  
Jordi Bruix ◽  
Won-Young Tak ◽  
Antonio Gasbarrini ◽  
Armando Santoro ◽  
Massimo Colombo ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line ◽  
Open Label ◽  
Second Line Therapy ◽  
Safety Study ◽  
Line Therapy ◽  
Open Label Phase
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