scholarly journals Efficacy and Safety of Transarterial Chemoembolization Combined With Anlotinib for Unresectable Hepatocellular Carcinoma: A Retrospective Study

2020 ◽  
Vol 19 ◽  
pp. 153303382096558
Author(s):  
Wenbo Guo ◽  
Song Chen ◽  
Zhiqiang Wu ◽  
Wenquan Zhuang ◽  
Jianyong Yang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Survival Rate ◽  
Transarterial Chemoembolization ◽  
Statistical Tests ◽  
Objective Response ◽  
Rank Test ◽  
P Value ◽  
Efficacy And Safety ◽  
Unresectable Hepatocellular Carcinoma ◽  
Survival Difference

Objective: This study aimed to explore the efficacy and safety of using transarterial chemoembolization (TACE) combined with anlotinib in patients with unresectable hepatocellular carcinoma, compared with TACE alone. Methods: This was a single-center study, retrospectively recruited 82 unresectable HCC patients who received either TACE alone (TA group; n = 46) or TACE combined with anlotinib (TC group; n = 36) between Jan 2018 and Jan 2019. The primary outcomes were progression-free survival (PFS) and overall survival (OS). While the secondary outcomes were the objective response rate (ORR), the disease control rate (DCR), and main complications. Log-rank test and Kaplan–Meier method was used to calculate the survival difference. All statistical tests were 2-sided and P value <0.05 were taken as statistically significant. Results: Patients in TC group had a significant higher PFS than those in TA group (7.35 months vs. 5.54 months, p = 0.035). Although 3-month survival rate in the 2 groups was not statistically different (97.2% vs. 93.5%, p = 0.627), the survival rate at 6 months and 1 year were strongly higher in TC group (83.3% vs. 56.5%, p = 0.016; 66.7% vs. 19.6%, respectively, p < 0.05). Furthermore, there was a significantly higher ORR in TC group, while no statistical difference existed in DCR. Neither treatment-related mortality nor grade 4 adverse events (AEs) occurred. However, 2 patients in TC group had grade 3 AEs (one suffered with erythra, and the other with hand-foot-skin reaction), which disappeared after prompt treatment. Conclusion: TACE combined with anlotinib is safe and may improve outcomes for unresectable HCC patients comparing with TACE alone. Randomized controlled trials are warranted to further evaluate treatment effects of anlotinib in HCC.

Efficacy and safety of anlotinib combined with transarterial chemoembolization versus transarterial chemoembolization alone in patients with unresectable hepatocellular carcinoma: A retrospective study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16611-e16611
Author(s):  
Wenbo Guo ◽  
Song Chen
Keyword(s):  
Hepatocellular Carcinoma ◽  
Retrospective Study ◽  
Survival Rate ◽  
Transarterial Chemoembolization ◽  
Objective Response ◽  
Progression Free Survival ◽  
Key Words Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Grade 3

e16611 Background: HCC is one of the most common cancer among all the malignant tumor, while the efficacy of TACE alone for unresectable HCC patients still remains unsatisfactory. With the development of targeted drug, more and more targeted drugs are applying to the treatment of HCC. Objective: The aim of the stidy is to investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with Anlotinib versus TACE alone in patients with unresectable HCC. Methods: This single-center retrospective study involved 82 patients with unresectable HCC who underwent TACE alone (TA group; n=46) or TACE combined with Anlotinib (TC group; n=36) between Jan 2018 and Jan 2019. The primary outcomes were progression-free survival (PFS) and overall survival (OS), while the secondary outcomes included the objective response rate (ORR), the disease control rate (DCR) and main complications. Results: The TC group showed relatively higher PFS than the TA group (7.35months vs. 5.54 months, p=0.035). The 3-month survival rate was not statistically different between the two groups (97.2% vs. 93.5%, p=0.627), while both the 6-month survival rate and 1-year survival rate were significantly higher in the TC group than in the TA group (83.3% vs. 56.5%, p=0.016; 66.7% vs. 19.6%, p<0.01). ORR in the TA group was significantly higher than in the TC group (77.8% vs. 32.6%, p<0.01), while the two groups showed no statistical difference in DCR (94.4% vs. 82.6%, p=0.17). No treatment-related mortality or grade 4 adverse event was observed, but grade 3 adverse events occurred in two patients in the TC group (one suffered with erythra, and another suffered with hand-foot-skin reaction). Both of them disappeared after prompt treatment. Conclusions: TACE combined with Anlotinib is safe and may improve outcomes for unresectable HCC patients comparing with TACE alone. It still needs more further randomized controlled trials to clarify the potential role of Anlotinib in hepatocellular carcinoma. Key words: Hepatocellular carcinoma; Anlotinib; Transarterial chemoembolization

scholarly journals Efficacy and Safety of Lenvatinib Therapy for Unresectable Hepatocellular Carcinoma in a Real-World Practice in Korea

Liver Cancer ◽  
2021 ◽  
pp. 1-11
Author(s):  
Myung Ji Goh ◽  
Joo Hyun Oh ◽  
Yewan Park ◽  
Jihye Kim ◽  
Wonseok Kang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Prognostic Factors ◽  
Disease Progression ◽  
Real World ◽  
Medical Center ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Unresectable Hepatocellular Carcinoma

<b><i>Background:</i></b> Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. <b><i>Methods:</i></b> A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. <b><i>Results:</i></b> A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4–9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. <b><i>Conclusion:</i></b> Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.

Prospective phase II trial of sorafenib combined with doxorubicin eluting bead-transarterial chemoembolization for patients with unresectable hepatocellular carcinoma: Efficacy analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4124-4124
Author(s):  
Jean-Francois Geschwind ◽  
Allen Feng ◽  
Diane K. Reyes ◽  
Ihab R. Kamel ◽  
Vivek Gowdra Halappa ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase Ii ◽  
Transarterial Chemoembolization ◽  
Phase Ii Study ◽  
Rank Test ◽  
Median Dose ◽  
Unresectable Hepatocellular Carcinoma ◽  
Significant Difference ◽  
Prospective Phase

4124 Background: This study reports the final analysis (n=50) of a prospective phase II study evaluating the efficacy of the combination of sorafenib and doxorubicin eluting bead transarterial chemoembolization (DEB-TACE) in patients with unresectable hepatocellular carcinoma (HCC). Methods: Protocol consisted of 6-week cycles with sorafenib at 800 mg/day beginning 1 week prior to DEB-TACE; up to 4 DEB-TACE treatments within 6 months. Tumor response was assessed by RECIST and EASL criteria using MRI at baseline and at 1 month follow-up. Time to untreatable progression (TTUP) was defined as the interval from initiation of sorafenib therapy until inability of patient to further receive intra-arterial therapy. Overall survival (OS) and TTUP were calculated with the Kaplan-Meier method; outcomes were stratified by BCLC A/B and C and compared with the log-rank test. Results: DEB-TACE + sorafenib successfully performed in 50 patients: mean 62yrs (range, 31-88 yrs), Child-Pugh A/B (92%/8%), BCLC A/B/C (10%/28%/62%), ECOG 0/1 (52%/48%), HCV/HBV (44%/8%), mean tumor burden 20%, mean tumor size 7.2cm (range, 1–17.6), and mean tumor enhancement 78%. Patients were enrolled for a median of 3 (range, 1-22) cycles including a median of 1 (range, 0-6) DEB-TACE procedure. Median dose regimen was 400mgQD and the median dose taken while on study was 318 mg/day (range, 100-800). 1 month follow-up showed a mean tumor enhancement reduction of 48.2% (n=46, p<0.001) and an average reduction in lesion diameter of 8.5%(n=48, p=0.02). The Disease Control Rate was 98% using the EASL amendment and RECIST. Median TTUP was 11.9 mths (95% CI, 1.8-22 mths) with a significant difference between BCLC A/B (median 22.9 mths) and BCLC C (median 6.2mths) patients (log-rank, p=0.01). Median OS was 24.5 mths (95% CI, 14.3-35 mths) with a significant difference between BCLC C (median 17.1 mths) and BCLC A/B (median 33.7 mths) patients (log-rank, p=0.001). Conclusions: The results of this phase II study suggest a potential benefit to the combination of sorafenib and DEB-TACE. Single arm and non-randomization are limitations of the study. Clinical trial information: NCT00844883.

Phase II Study of the Efficacy and Safety of Cisplatin-Epinephrine Injectable Gel Administered to Patients With Unresectable Hepatocellular Carcinoma

2003 ◽  
Vol 21 (4) ◽  
pp. 652-658 ◽  
Author(s):  
T.W.T. Leung ◽  
S. Yu ◽  
P.J. Johnson ◽  
J. Geschwind ◽  
T.J. Vogl ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Tumor Necrosis ◽  
Progressive Disease ◽  
Objective Response ◽  
Survival Rates ◽  
Median Number ◽  
Efficacy And Safety ◽  
End Points ◽  
Local Ablation ◽  
Unresectable Hepatocellular Carcinoma

Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured ≤ 7 cm, total tumor volume ≤ 200 cm3). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects. Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

scholarly journals REFLECT—a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset

2019 ◽  
Vol 55 (1) ◽  
pp. 113-122 ◽  
Author(s):  
Tatsuya Yamashita ◽  
Masatoshi Kudo ◽  
Kenji Ikeda ◽  
Namiki Izumi ◽  
Ryosuke Tateishi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Japanese Population ◽  
Objective Response ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Unresectable Hepatocellular Carcinoma

Abstract Background A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79–1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported. Methods The intent-to-treat population enrolled in Japan was analyzed. Results Of 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62–1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm. Conclusions The efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC. Trial registration ID ClinicalTrials.gov. No. NCT01761266.

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