Improvement in survival of advanced hepatocellular carcinoma patients: Results of an updated period analysis of SEER database.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 383-383
Author(s):  
Binay Kumar Shah ◽  
Amit Bhandari ◽  
Krishna Bilas Ghimire ◽  
Sajani Manandhar
Keyword(s):  
Hepatocellular Carcinoma ◽  
Survival Rates ◽  
Relative Survival ◽  
Advanced Hepatocellular Carcinoma ◽  
Younger Patients ◽  
Advanced Hcc ◽  
Fda Approval ◽  
Seer Data ◽  
Z Value ◽  
Improvement In Survival

383 Background: Sorafenib was approved by FDA for treatment of advanced unresectable hepatocellular carcinoma (HCC) patients in November 2007. In this study, we update survival trends in advanced HCC using Surveillance, Epidemiology, and End Results (SEER) data. Methods: We selected patients with advanced HCC diagnosed from January 2001 to December 2010 from SEER 18 registries. We excluded diagnosed at autopsy, from death certificate only, or those without survival date. We calculated 1- and 2- year relative survival rates in pre-sorafenib (2001-2007) and post-sorafenib (2008-2010) era by age, sex and ethnicity among using SEER*stat software. Results: The total number of advanced HCC patients during 2001-2010, 2001-2007 and 2008-2010 were 5,092, 2,747 and 2,345 respectively. The 1- and 2- year survival rates of patients improved significantly from pre-sorafenib era to post-sorafenib era (1 year RS: 17.20±0.7% to 19.90±0.80%, Z=2.63; 2 year RS: 8.00±0.5% to 8.7±0.60%, Z=2.31). Survival rates of male patients improved significantly in post-sorafenib era (1 year RS: 16.4±0.80 to 19.4±0.90%, Z=2.18; 1 year RS: 7.4±0.60% to 8.6±0.70%, Z=2.18). There was no improvement in survival rates of female patients. Similarly, younger patients had improvement in survival rates in post-sorafenib era compared to pre-sorafenib era (1 year Z value 2.46; 2 year Z value 2.23). There was no improvement in survival rates of older patients. Conclusions: Since FDA approval of sorafenib, survival rates of patients with advanced hepatocellular carcinoma have improved. The improvement in survival rates is limited to males and younger patients

Survival of elderly patients with advanced hepatocellular carcinoma with distant metastasis in pre- and post- sorafenib era: A population based study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15643-e15643 ◽  
Author(s):  
Nibash Budhathoki ◽  
Binay Kumar Shah
Keyword(s):  
Hepatocellular Carcinoma ◽  
Elderly Patients ◽  
Distant Metastasis ◽  
Survival Rates ◽  
Relative Survival ◽  
Population Based ◽  
P Value ◽  
Advanced Hepatocellular Carcinoma ◽  
Significant Difference ◽  
Improvement In Survival

e15643 Background: Sorafinib was approved for advanced hepatocellular carcinoma in 2007. This study was conducted to study relative survival in elderly patients with advanced hepatocellular carcinoma in presorafinib and sorafinib era. Methods: We selected elderly patients (age ≥ 65 years) with advanced hepatocellular carcinoma (distant metastasis based on SEER’s LRD staging) from the Surveillance, Epidemiology, and End Results (SEER) database diagnosed during January 2000 to December 2013. We calculated one year and five year relative survival rates in pre- (2000-2006) and post- sorafinib (2008-2013) era by sex and ethnicity (Caucasians, African-Americans (AA) & Other) using SEER*Stat software. Results: There were total of 1533 patients in presorafinib era and 1694 patients in postsorafinib era. Of the total population, 71.30% were male and 28.70% female, 71% were Caucasian, 10% African-American and 19% were other race. Median age of patients was 73 years (65-99 years) and medial follow up period was 3 months (0-167 months) Survival rates improved significantly from pre- to post- sorafenib era (1 year RS: 10.60% ±0.80% vs 12.10±0.90%, p value = 0.001; 5 year RS: 1.10%±0.30% vs 1.8%±0.6%, p value = 0.001 ). The survival rate improved significantly for male (1 year RS: 11.60%±1.00% vs 12.30%±1.00%, p value = 0.006; 5 year RS: 1.00%±0.40% vs 1.3%± 0.6% , p value = 0.007) and Caucasian (1 year RS: 10.60%±1.00% vs 12.60%±1.10%, p value = 0.0008; 5 year RS: RS = 1.20%±0.40% vs 1.4%±0.7%, P value = 0.001) patients in post sorafenib era. There was no significant difference in the survival rates among any other cohorts examined.However in black (N = 153 vs 158 , RS = 6.80%±2.10% vs 7.80%±2.40% , p value = 0.77) or other races (N = 311 vs 311, RS = 12.20%±1.90% vs 12.80%±2.10%, p value = 0.30 ) , no significant improvement in survival was noted. Conclusions: Our study showed that relative survival rates of elderly patients with advanced hepatocellular carcinoma with distant metastasis has improved in the post-sorafenib compared to pre-sorafenib era. The improvement in survival is limited to male and Caucasian patients.

scholarly journals Ipilimumab and nivolumab/pembrolizumab in advanced hepatocellular carcinoma refractory to prior immune checkpoint inhibitors

2021 ◽  
Vol 9 (2) ◽  
pp. e001945 ◽  
Author(s):  
Jeffrey Sum Lung Wong ◽  
Gerry Gin Wai Kwok ◽  
Vikki Tang ◽  
Bryan Cho Wing Li ◽  
Roland Leung ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Acquired Resistance ◽  
Survival Rates ◽  
Advanced Hepatocellular Carcinoma ◽  
Primary Resistance ◽  
Advanced Hcc

BackgroundProgrammed cell death protein 1 (PD-1) pathway blockade with immune checkpoint inhibitors (ICIs) is a standard therapy in advanced hepatocellular carcinoma (HCC) nowadays. No strategies to overcome ICI resistance have been described. We aimed to evaluate the use of ipilimumab and anti-PD-1 ICIs (nivolumab or pembrolizumab) combinations in patients with advanced HCC with progression on prior ICIs.MethodsPatients with advanced HCC with documented tumor progression on prior ICIs and subsequently received ipilimumab with nivolumab/pembrolizumab were analyzed. Objective response rate (ORR), median duration of response (DOR), time-to-progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were assessed.ResultsTwenty-five patients were included. The median age was 62 (range: 51–83). About 68% were of Child-Pugh (CP) Grade A and 48% had primary resistance to prior ICI. At median follow-up of 37.7 months, the ORR was 16% with a median DOR of 11.5 months (range: 2.76–30.3). Three patients achieved complete response. The median TTP was 2.96 months (95% CI: 1.61 to 4.31). Median OS was 10.9 months (95% CI: 3.99 to 17.8) and the 1 year, 2 year and 3 year survival rates were 42.4%, 32.3% and 21.6%, respectively. The ORR was 16.7% in primary resistance group and 15.4% in acquired resistance group (p=1.00). All responders were of CP A and Albumin-Bilirubin (ALBI) Grade 1 or 2. CP and ALBI Grades were significantly associated with OS (p=0.006 and p<0.001, respectively). Overall, 52% of patients experienced TRAEs and 12% experienced Grade 3 or above TRAEs.ConclusionsIpilimumab and nivolumab/pembrolizumab can achieve durable antitumor activity and encouraging survival outcomes with acceptable toxicity in patients with advanced HCC who had prior treatment with ICIs.

Combination therapy of intra-arterial 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced hepatocellular carcinoma.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 216-216
Author(s):  
Kazuhiro Kasai ◽  
Kei Sawara ◽  
Kazuyuki Suzuki
Keyword(s):  
Hepatocellular Carcinoma ◽  
Survival Rates ◽  
Pegylated Interferon ◽  
Early Response ◽  
The Other ◽  
Advanced Hepatocellular Carcinoma ◽  
Arterial Infusion ◽  
Cumulative Survival ◽  
Advanced Hcc ◽  
Sorafenib Group

216 Background: Two recent phase III clinical trials have shown that sorafenib improves the survival in patients with advanced hepatocellular carcinoma (HCC). However, patients with HCC and portal vein tumor thrombosis (PVTT) usually have very short survival even when treated with sorafenib. On the other hand, recent advances in implantable drug delivery systems have made it possible to administer repeated hepatic arterial infusion chemotherapy (HAIC) agent. Since 2006, we have treated the patients displaying advanced HCC with PVTT by combined HAIC of 5-fluorouracil (5-FU) and systemic pegylated interferon (PEG-IFN)α-2b, and reported favorable results. In this article, we evaluated the efficacy of combined 5-FU and PEG-IFN α-2b, and compared outcomes between advanced HCC patients with PVTT treated using sorafenib. Methods: Forty patients with HCC and PVTT were enrolled. Of these, 21 patients were treated using subcutaneous administration of PEG-IFNα-2b and intra-arterial infusion of 5-FU [5-FU / PEG-IFN group], 19 patients were treated using continuous oral treatment with 400-800 mg of sorafenib [Sorafenib group]. We compared the early response to the therapy and the cumulative survival rate between these two groups. Results: The objective early response rate in the 5-FU / PEG-IFN group was significantly higher than that in the Sorafenib group (71.4 vs. 10.5%, P<0.01). The cumulative survival rates at 6, 12, 18, and 24 months, respectively, were 83.8, 77.8, 55.6, and 55.6% in the 5FU / PEG-IFN group, and 68.4, 37.7, 16.2, and 16.2% in the Sorafenib group. The cumulative survival rates was significantly higher in the 5FU / PEG-IFN group than in the Sorafenib group (P=0.03). Serious complications and treatment-related deaths were not observed in the 5FU / PEG-IFN group. On the other hand, the rate of discontinuation of treatment due to adverse events was 36.8% of the patients who were treated sorafenib. Conclusions: Based on our findings, this newly developed combination therapy may be useful for patients with advanced HCC, although a large-scale randomized controlled study by comparison with sorafenib is needed.

Role and strategies of radiofrequency ablation in treating advanced hepatocellular carcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14701-e14701
Author(s):  
Min Hua Chen ◽  
Wei Yang ◽  
Jie Wu ◽  
Wei Wu ◽  
Kun Yan
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Radiofrequency Ablation ◽  
Survival Rates ◽  
Treatment Strategies ◽  
Percutaneous Ablation ◽  
Advanced Hepatocellular Carcinoma ◽  
Advanced Hcc ◽  
Tnm System ◽  
Liver Protection

e14701 Background: To investigate the application value and strategies of ultrasound-guided percutaneous radiofrequency ablation (RFA) in treating advanced hepatocellular carcinoma (HCC) which is common in china. Methods: A total of 655 patients with unresectablely advanced HCC underwent percuatenous RFA therapy and 92 patients with 136 tumors among them were enrolled into the study. According to the 6th UICC/AJCC-TNM system, 82 and 10 patients were in stage III and IV, respectively. The tumor size ranged from 1.5 to 8.0 cm (mean±SD, 4.5±1.6 cm). 59 patients had solitary tumor and the remaining 33 patients had multiple tumors. The Child-Pugh classification of A, B and C were 58,32 and 2 patients, respectively. Established strategies included: (1) select RFA indications based on the contrast-enhanced ultrasound (CEUS) results; (2) design radical protocols based on invasive range showed by CEUS; (3) multiple overlapping ablations based on mathematical protocol; (4) two or three bipolar RFA electrodes with three dimensional localization; (5) color US guided percutaneous ablation of tumor feeding artery (including TACE) + RFA for HCC with rich supply. The patients underwent follow-up using enhanced CT at one month, and then every three months after RFA. The ablation was considered a success if no abnormal enhancement or wash-out was detected in the treated area on the CT scan at one month. All patients after RFA received liver protection treatments. Overall survival was estimated by Kaplan-Meier analysis. Results: Early complete tumor necrosis rate after initial RFA was 90.4% (123/136 tumors). Serious complications were developed in two patients (2.2%) and no treatment-related death occurred. 3~129 months were followed up. Local recurrence rate was 15.4 %(21/136 tumors). The 1-, 3-, 5-year overall survival rates were 83.3 %, 48.3 %, 21.9%, respectively, and the median survival time was 35 months. Conclusions: RFA treatment of advanced HCC proved to be feasible. Paying attention to apply treatment strategies and liver protection therapies in RFA can effectively improve the survival.

Survival In Adult Acute Lymphoblastic Leukemia Survival By Age, Gender and Ethnicity

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1696-1696 ◽  
Author(s):  
Krishna B Ghimire ◽  
Binay K. Shah
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Conflicts Of Interest ◽  
Lymphoblastic Leukemia ◽  
Survival Rates ◽  
Relative Survival ◽  
Younger Patients ◽  
Adult Acute Lymphoblastic Leukemia ◽  
Time Periods ◽  
Improvement In Survival ◽  
End Results

Abstract Background Studies have shown improvement in survival in adult acute lymphoblastic leukemia (ALL) with the use of risk-directed therapy pediatric-inspired regimens. We analyzed US Surveillance, Epidemiology and End Results (SEER) cancer registry database to evaluate whether survival of adult ALL patients has improved in general population. Methods We analyzed US Surveillance, Epidemiology and End Results (SEER) 18 registries using survival session to calculate relative survival rates (RS) during 1973-1989, 1990-1999 and 2000-2009 among adult (≥20 years) ALL patients. We used Z-test in the SEER*Stat software to compare the relative survival rates in several cohorts categorized by race, gender, and age groups (20-39, ≥ 40 years). Results There were 7,435 adult ALL patients reported in SEER 18 registries during 1973-2009. The majority of patients were Caucasian (85%) and Male (57%). The relative survival rates for adult ALL patients between 1973-2009 were 55.8±0.6% and 25.0±0.5% at 1 year and 5 years respectively. The relative survival rates improved significantly for each successive time periods, with an improvement from 45.4%, to 51.6%, to 60.6% at 1 year and, from 15.3%, to 23.7%, to 29.0% at 5 years for time periods 1973-1989, 1990-1999 and 2000-2009 respectively. For younger patients (age 20-39 years), 1- and 5-year RS rates improved from 1973-1989 to 1990-1999 but not from 1990-1999 to 2000-2009. For older patients (age ≥40 years) RS improved for each successive time periods. The 1- and 5- year relative survival rates improved significantly for both male and female patients during successive time periods. Interestingly, although there was significant improvement in survival rates at 1- and 5- years for Caucasians, improvement was not seen for AA adult ALL patients during subsequent time periods examined. Conclusions Although adult ALL survival rates have improved for most cohorts examined, the survival of African American patients has not improved. Similarly, survival rates of younger patients (20-39 years) has not improved from 1990-1999 to 2000-2009. Disclosures: No relevant conflicts of interest to declare.

Chronic Myeloid Leukemia Survival in Older Population in Pre- and Post- Imatinib Era in the United States

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4237-4237 ◽  
Author(s):  
Krishna B Ghimire ◽  
Binay K. Shah
Keyword(s):  
Randomized Clinical Trials ◽  
Conflicts Of Interest ◽  
Survival Rates ◽  
Age Groups ◽  
Relative Survival ◽  
The United States ◽  
Published Data ◽  
Gender And Age ◽  
Z Value ◽  
Improvement In Survival

Abstract Abstract 4237 Background: Median age at diagnosis for CML is 64 years of age. CML survival in elderly population is not well studied. This study was conducted to evaluate the relative survival rates among CML patients older than 50 years in pre- (1991–2000) and post- (2001– 2009) imatinib era. Methods: We analyzed the Surveillance, Epidemiology, and End Results (SEER*Stat) 18 registry database to compare 3-year and 5-year relative survival rates among CML patients by gender and age groups (50–69, ≥70) from the pre- (1991–2000) to post- imatinib eras (2001–2009). We used Z-test in the SEER*Stat program to calculate the differences in relative survival rates among different cohorts. Results: The 3-year and 5-year relative survival rates for CML patients age ≥50 years in pre- (n=3,848) vs post- (n=6,501) imatinib era were: 44.1±0.9% vs 55.9±0.8%, p=<0.0001, Z-value=10.179 at 3-years and 31.4±0.9% vs 46.9±0.9%, p=<0.0001, Z-value=12.361 at 5-years. The 3-year and 5-year relative survival rates for old (50–69) patients in pre- (n=1,723) vs post- (n=3011) imatinib era were: 57.7 ± 1.2% vs 72.3 ±1.0%, p=<0.0001, Z-value=9.454 at 3 years and 44.8±1.3% vs 64.3±1.2%, P=<0.0001, Z-value= 11.365 at 5 years. The survival rates for elderly (≥70) patients in pre (n= 2,125) and post (n=3,490) imatinib era were: 32.4±1.2% and 41.3±1.1%, p=<0.0001, Z-value=5.806 at 3 years and 19.3±1.1% and 31.2±1.2%, P=<0.0001, Z-value=7.135 at 5 years respectively. Table 1 shows CML survival rates by age and sex in patients older than 50 years of age. Conclusions: This study showed significant increase in 3 year and 5 year relative survival rates in post- imatinib era among CML patients older than 50 in all cohorts examined. However, the improvement in survival rates is modest compared to published data from randomized clinical trials. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Effect of the Hypoxia Inducible Factor on Sorafenib Resistance of Hepatocellular Carcinoma

2021 ◽  
Vol 11 ◽  
Author(s):  
Zhi Zeng ◽  
Qiliang Lu ◽  
Yang Liu ◽  
Junjun Zhao ◽  
Qian Zhang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Poor Prognosis ◽  
Kinase Inhibitor ◽  
Hypoxia Inducible Factor ◽  
Survival Rates ◽  
Advanced Hepatocellular Carcinoma ◽  
First Line ◽  
Advanced Hcc ◽  
The Impact ◽  
Line Drug

Sorafenib a multi-target tyrosine kinase inhibitor, is the first-line drug for treating advanced hepatocellular carcinoma (HCC). Mechanistically, it suppresses tumor angiogenesis, cell proliferation and promotes apoptosis. Although sorafenib effectively prolongs median survival rates of patients with advanced HCC, its efficacy is limited by drug resistance in some patients. In HCC, this resistance is attributed to multiple complex mechanisms. Previous clinical data has shown that HIFs expression is a predictor of poor prognosis, with further evidence demonstrating that a combination of sorafenib and HIFs-targeted therapy or HIFs inhibitors can overcome HCC sorafenib resistance. Here, we describe the molecular mechanism underlying sorafenib resistance in HCC patients, and highlight the impact of hypoxia microenvironment on sorafenib resistance.

Is Noncurative Hepatic Resection Justified for Advanced Hepatocellular Carcinoma?

2018 ◽  
Vol 84 (12) ◽  
pp. 1938-1944 ◽  
Author(s):  
Seikan Hai ◽  
Etsuro Hatano ◽  
Toshihiro Okada ◽  
Naoki Uyama ◽  
Kazuhiro Suzumura ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatic Resection ◽  
Clinical Course ◽  
Survival Rates ◽  
Advanced Hepatocellular Carcinoma ◽  
Remnant Liver ◽  
Advanced Hcc ◽  
Group A ◽  
Group B ◽  
Group D

It has been obscure whether or not noncurative hepatic resection (Hx) has a favorable impact on the clinical course in patients with advanced hepatocellular carcinoma (HCC). The aim of this study is to clarify the significance of noncurative Hx for advanced HCC. Among 666 consecutive patients undergoing Hx for HCC in our department, 79 patients underwent noncurative Hx. These patients were classified as Group A (presence of macrovascular invasion [MVI]; n = 29), Group B (residual tumors in the remnant liver; n = 37), Group C (residual tumors in the remnant liver with MVI; n = 7), or Group D (residual tumors in the remnant liver with distant metastasis [with or without MVI]; n = 6). The three-year survival rates were 49.6 per cent in Group A, 30.3 per cent in Group B, 14.3 per cent in Group C, and 0.0 per cent in Group D, respectively (Groups A and B vs Group D, P < 0.05). Moreover, the survival rate was significantly higher in patients with ≤3 tumors than in those with ≥4 tumors ( P < 0.05), when Group B was divided into subgroups according to the number of residual tumors in the remnant liver. In conclusion, noncurative Hx might be acceptable for advanced HCC with MVI or ≤3 residual tumors in the remnant liver.

Ethnic Disparities in Survival of Chronic Myeloid Leukemia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1272-1272
Author(s):  
Krishna B Ghimire ◽  
Binay K. Shah
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Kinase Inhibitors ◽  
Conflicts Of Interest ◽  
Survival Rates ◽  
Ethnic Disparities ◽  
Relative Survival ◽  
Ethnic Disparity ◽  
Z Value ◽  
Improvement In Survival

Introduction: Development of tyrosine kinase inhibitors has led to significant improvement in survival of chronic myeloid leukemia (CML) patients. We conducted this study to evaluate any ethnic disparity in CML survival. Methods: We analyzed surveillance, Epidemiology, and End Results, SEER 18 registry to compare 1 and 3 years relative survival rates of CML patients diagnosed between 2001- 2008 by ethnicity - Caucasian, African American (AA), Others (O). We analyzed survival rates by age (≤65, >65), and time periods: (2001-2004) and (2005-2008). We used SEER*Stat software to calculate Z value. Results: There were 6,306 CML patients during (2001-2008); 3,111 during (2001-2004) and 3,195 during (2005-2008). The 1-year relative survival rates among Caucasians (n=6,306), AA (n=790), and Others (n=532) were 80.0±0.5%, 83.8 ±1.4%, and 84.0±1.7% [Z value 2.43 (AA vs Caucasian), 2.15 (O vs Caucasian)] respectively. The 3 years RS rates were 65.6±0.7%, 70.2±1.8%, and 70.9 ±2.1% respectively with Z value 2.49 (AA vs Caucasian) and 2.42 (Caucasian vs O). Among younger patients (age ≤65 years, n=4,245) Caucasians had better RS compared to AA (83.1±0.7% vs 78.7±1.8%, Z value 2.24) at 3 years. There was no difference survival at 1and 3 years in older patients (age >65 years, n= 3,383). The survival rates of patients diagnosed during 2001-2004 were similar for all ethnic groups. Among patients diagnosed during 2005-2008, survival rates were significantly higher for AA versus Caucasians (1 year RS 86.6±1.8% vs 81.3±0.7%, Z value 2.45, and 3 year RS 73.8±2.4% vs 68.3±0.9%, Z value 2.20). Others also had better RS compared to Caucasians (87.1±2.1% vs 81.3±0.7%, Z value 2.22) at 1 year. There was no racial disparity in survival rates when analyzed by age (≤65 and >65) and sex at 1 and 3 years during 2001-2004 and 2005-2008. Conclusions: Our study showed that there is ethnic disparity in CML survival. Among CML patients diagnosed during 2005-2008, AA and Other races had superior survival rates compared to Caucasians. Disclosures No relevant conflicts of interest to declare.

Trans-catheter arterial p53-gene-embolization using gelatin sponge particles in treatment of patients with advanced hepatocellular carcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15024-e15024
Author(s):  
Yuewei Zhang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Survival Rates ◽  
P53 Gene ◽  
Gelatin Sponge ◽  
Advanced Hepatocellular Carcinoma ◽  
Serious Adverse Events ◽  
Advanced Hcc ◽  
Gelatin Sponge Particles ◽  
Radio Therapy ◽  
One Year

e15024 Background: Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients’ poor condition, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can’t tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate TAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC. Methods: Fifty-eight patients with advanced, unresectable HCC were randomly to two groups: TAE plus p53 group (TAE-p53G), or TAE group (TAEG). The study patients included 56 males and 2 females with an average age of 62.5 (53-89) years old and with Child-Pugh score A or B (42 or 16, respectively). The patients received 3 times of TAE plus rAd-p53 for TAE-p53G or TAE only for TAEG, once in a month for 3 months. The TAE materials consist of gelatin sponge particles (GSP) alone or plus 2-4 x 1012viral particles of rAd-p53, mixed into 30 ml suspension. The study endpoints included response rate, one-year survival, liver function, and adverse effects. Results: After 3-5 days of the first treatment, CT scan showed deceased tumor density in all the study cases. At 6 months after the first treatment, based on the RECIST standard, 31.0% (9/29) and 51.7% (15/29) patients in TAE-p53G achieved a complete response (CR) and partial response (PR), respectively, versus 17.2% (5/29) and 37.9% (11/29) of CR and PR in TAEG, respectively. One-year survival rates were 79.4% and 60.7% with median survival time of 11.7 and 8.3 months for TAE-p53G and TAEG, respectively. There are no significant changes of liver functions in both groups after treatment. Mild or median fever was observed in all the patients in TAE-p53G. No serious adverse events or complications observed. Conclusions: TAE using GSPs plus rAd-p53 is effective and safe treatments for advanced HCC.

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