scholarly journals Efficacy and Safety of 4 Fractions of Carbon-Ion Radiation Therapy for Hepatocellular Carcinoma: A Prospective Study

Liver Cancer ◽  
2021 ◽  
pp. 1-14
Author(s):  
Kei Shibuya ◽  
Hiroyuki Katoh ◽  
Yoshinori Koyama ◽  
Shintaro Shiba ◽  
Masahiko Okamoto ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Prospective Study ◽  
Performance Status ◽  
Survival Rates ◽  
International Normalized Ratio ◽  
Serious Adverse Events ◽  
Significant Deterioration ◽  
Safety And Efficacy ◽  
Carbon Ion ◽  
Curative Therapy

<b><i>Introduction:</i></b> Prospective evidence supporting the safety and efficacy of carbon-ion radiotherapy (C-ion RT) for hepatocellular carcinoma (HCC) remains lacking. This prospective study aimed to evaluate the safety and efficacy of hypofractionated C-ion RT in patients with HCC. <b><i>Methods:</i></b> The inclusion criteria were as follows: (1) pathologically or clinically diagnosed HCC; (2) measurable tumor and tumor size ≤10 cm; (3) absence of major vascular invasion; (4) no extrahepatic metastasis; (5) the alimentary tract was not adjacent to the target lesion (&#x3e;1 cm); (6) not suitable for or refusal to undergo surgery or local ablative therapies; (7) an interval ≥4 weeks from previous therapy; (8) no other intrahepatic lesion or at least 2 years after the previous curative therapy; (9) performance status score, 0–2; and (10) Child-Pugh score, 5–9. The prescribed C-ion RT dose was 52.8 Gy (relative biological effectiveness [RBE]) or 60.0 Gy (RBE) in 4 fractions. <b><i>Results:</i></b> In total, 35 patients with HCC were enrolled between October 2010 and May 2016. The median follow-up durations in the survivor group (<i>n</i> = 23) and in the whole cohort were 55.1 and 49.0 months, respectively. The 2-, 3-, and 4-year overall survival rates were 82.8%, 76.7%, and 69.4%, respectively. The 2-, 3-, and 4-year local control (LC) rates were 92.6%, 76.5%, and 76.5%, respectively. The median time-to-progression was 25.6 months (95% confidence interval, 13.7–37.5 months). Grade 4 or 5 toxicities were not observed. Grade 3 acute and late toxicities were observed in 2 patients. There was no significant deterioration in serum albumin, bilirubin, prothrombin time-international normalized ratio, platelet count, or Child-Pugh score after C-ion RT. <b><i>Conclusion:</i></b> Four fractions of C-ion RT for HCC did not yield serious adverse events and showed promising LC, thus making it a safe and effective modality for this type of malignancy.

Phase II Trial of Carcinoembryonic Antigen Radioimmunotherapy With 131I-Labetuzumab After Salvage Resection of Colorectal Metastases in the Liver: Five-Year Safety and Efficacy Results

2005 ◽  
Vol 23 (27) ◽  
pp. 6763-6770 ◽  
Author(s):  
Torsten Liersch ◽  
Johannes Meller ◽  
Bettina Kulle ◽  
Thomas M. Behr ◽  
Peter Markus ◽  
...  
Keyword(s):  
Carcinoembryonic Antigen ◽  
Phase Ii ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Colorectal Metastases ◽  
Resection Margins ◽  
Safety And Efficacy ◽  
Curative Therapy ◽  
Salvage Resection ◽  
Grade 3

Purpose Although complete resection (R0) of liver metastases (LM) remains the treatment of choice for colorectal cancer (CRC) patients amenable to curative therapy, only approximately one third survive for 5 years. The objective of this phase II study was to evaluate the safety and efficacy of radioimmunotherapy (RAIT) after salvage resection of LM. Patients and Methods Twenty-three patients who underwent surgery for LM of CRC received a dose of 40 to 60 mCi/m2 of 131I-labetuzumab, which is a humanized monoclonal antibody against carcinoembryonic antigen. Safety (n = 23), disease-free survival (DFS; n = 19), and overall survival (OS; n = 19) were determined. Results With a median follow-up of 64 months, the median OS time from the first liver resection for RAIT patients was 68.0 months (95% CI, 46.0 months to infinity), and the median DFS time was 18.0 months (95% CI, 11.0 to 31.0 months). The 5-year survival rate was 51.3%. RAIT benefited patients independently of bilobar involvement, size and number of LM, and resection margins. The major adverse effect was transient myelosuppression, resulting mostly in grade ≤ 3 neutropenia and/or thrombocytopenia. Conclusion Because both the median OS and 5-year survival rates seem to be improved with adjuvant RAIT after complete LM resection in CRC, compared with historical and contemporaneous controls not receiving RAIT, these results justify further evaluation of this modality in a multicenter, randomized trial.

scholarly journals A genomic-clinical nomogram predicting recurrence-free survival for patients diagnosed with hepatocellular carcinoma

PeerJ ◽  
2019 ◽  
Vol 7 ◽  
pp. e7942
Author(s):  
Junjie Kong ◽  
Tao Wang ◽  
Shu Shen ◽  
Zifei Zhang ◽  
Xianwei Yang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Risk Model ◽  
Cox Regression ◽  
Group Performance ◽  
Performance Status ◽  
Survival Rates ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Recurrence Free Survival ◽  
Free Survival

Liver resection surgery is the most commonly used treatment strategy for patients diagnosed with hepatocellular carcinoma (HCC). However, there is still a chance for recurrence in these patients despite the survival benefits of this procedure. This study aimed to explore recurrence-related genes (RRGs) and establish a genomic-clinical nomogram for predicting postoperative recurrence in HCC patients. A total of 123 differently expressed genes and three RRGs (PZP, SPP2, and PRC1) were identified from online databases via Cox regression and LASSO logistic regression analyses and a gene-based risk model containing RRGs was then established. The Harrell’s concordance index (C-index), receiver operating characteristic (ROC) curves and calibration curves showed that the model performed well. Finally, a genomic-clinical nomogram incorporating the gene-based risk model, AJCC staging system, and Eastern Cooperative Oncology Group performance status was constructed to predict the 1-, 2-, and 3-year recurrence-free survival rates (RFS) for HCC patients. The C-index, ROC analysis, and decision curve analysis were good indicators of the nomogram’s performance. In conclusion, we identified three reliable RRGs associated with the recurrence of cancer and constructed a nomogram that performed well in predicting RFS for HCC patients. These findings could enrich our understanding of the mechanisms for HCC recurrence, help surgeons predict patients’ prognosis, and promote HCC treatment.

scholarly journals One Single Site Clinical Study: To Evaluate the Safety and Efficacy of Immunotherapy With Autologous Dendritic Cells, Cytokine-Induced Killer Cells in Primary Hepatocellular Carcinoma Patients

2020 ◽  
Vol 10 ◽  
Author(s):  
Kaiyue Xu ◽  
Zhengjie Meng ◽  
Xiaoxin Mu ◽  
Beicheng Sun ◽  
Yi Chai
Keyword(s):  
Hepatocellular Carcinoma ◽  
Dendritic Cells ◽  
Survival Rates ◽  
Clinical Effectiveness ◽  
Radical Resection ◽  
Primary Hepatocellular Carcinoma ◽  
Safety And Efficacy ◽  
Cik Cells ◽  
Relapse Time

Dendritic cells (DCs) and cytokine-induced killer (CIK) cells play an important role in the anti-tumor immune response. In this study, we evaluated the clinical effectiveness of DC/CIK-CD24 immunotherapies to primary hepatocellular carcinoma patients who received radical resection. 36 resected primary hepatocellular carcinoma (HCC) patients were enrolled from August 2014 to December 2015. All patients received two or four times of DC/CIK immunotherapy after radical resection. 1–4 years patients’ survival rates were evaluated during the follow-up. The 4-year survival rate of patients who received two times of immunotherapy was 47.1%, and the rate of those who received four times of immunotherapies was 52.6%. Compared to baseline, after receiving the DC/CIK-CD24 autotransfusion, the serum Treg concentration of the patients decreased, while CD3+, CD4+, CD56+ increased slightly. The adverse effect of immunotherapy was I–II° transient fever and could be tolerable. DC/CIK-CD24 immunotherapy can delay the relapse time.

Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis

Cancer ◽  
2015 ◽  
Vol 121 (13) ◽  
pp. 2164-2174 ◽  
Author(s):  
Nima Kokabi ◽  
Juan C. Camacho ◽  
Minzhi Xing ◽  
Bassel F. El-Rayes ◽  
James R. Spivey ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Portal Vein ◽  
Prospective Study ◽  
Portal Vein Thrombosis ◽  
Open Label ◽  
Safety And Efficacy ◽  
Vein Thrombosis ◽  
Yttrium 90

Two-fraction carbon ion radiotherapy for hepatocellular carcinoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15134-15134
Author(s):  
H. Kato ◽  
S. Yasuda ◽  
S. Yamada ◽  
R. Hara ◽  
M. Kano ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Dose Group ◽  
Karnofsky Performance Status ◽  
Therapeutic Option ◽  
Performance Status ◽  
Carbon Ion Radiotherapy ◽  
Hepatic Disorder ◽  
Carbon Ion ◽  
Minimal Invasiveness

15134 Background: In Japan, most patients with Hepatocellular Carcinoma (HCC) have liver cirrhosis, an advanced hepatic disorder, and they often require repeated therapies owing to the multicentric nature of carcinogenesis in the cirrhotic liver. Therefore, both radical effect and minimal invasiveness are essential for the treatment of HCC. However, there were no therapies satisfying both of these essential requirements for every-sized HCC. The purpose of this trial was to evaluate the safety and efficacy of two-fraction carbon ion radiotherapy (CIRT) for HCC. Methods: Eligibility criteria for this study were as follows: biopsy-proven HCC; recurrent or residual tumor after other ineffective treatments or no indication for any other treatment; no prior radiotherapy for target tumors; hepatic disorder of Child-Pugh grade A or B; Karnofsky performance status of 60–100; no other active cancer; and digestive tract not in contact with clinical target volume. CIRT was administered within dose escalation study of 32.0 to 38.8 cobalt gray equivalent (GyE) in 2 fractions for 2 days. Results: Between April 2004 and August 2006, 40 patients were totally enrolled. All patients had chronic liver diseases of Child-Pugh grade A in 37, B in 3. The median tumor size was 4.7 cm in diameter (2.0 to 6.7 cm). During a median follow-up of 32 months (range, 5–45 months), no hepatic failure resulting from the therapy and no treatment-related death occurred. Incidence of grade 3 early hepatic toxicity according to NCI-CTC ver.2 in the essential valuables concerning hepatic function was 0% in serum-GPT, ALB, prothrombin activity (PT%) and ALP, and 3% in T.BIL. No grade 4 toxicity has occurred. In 94% and 86% out of the patients, Child-Pugh score did not increase by more than 1 point in the early and late phases, respectively. In the lower-dose group (32.0, 33.6, 35.2 GyE: n=18), 2-year local control rate and overall survival rate were 71% and 83%, respectively. In the higher-dose group (37.0, 38.8 GyE: n=22), they were 100% and 90%, respectively. Conclusions: Although 2-fraction carbon ion radiotherapy seems to be safe and effective, and to have a promising potential as a new, radical, and minimally invasive therapeutic option for Hepatocellular Carcinoma, further careful follow-up is needed to confirm it’s clinical efficacy. No significant financial relationships to disclose.

Establishment of disease-specific graded prognostic assessment for patients with hepatocellular carcinoma and spinal metastasis.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 433-433
Author(s):  
Chai Hong Rim ◽  
Chiwhan Choi ◽  
Jinhyun Choi ◽  
Jinsil Seong
Keyword(s):  
Hepatocellular Carcinoma ◽  
High Risk ◽  
Group Performance ◽  
Spinal Metastasis ◽  
Performance Status ◽  
Survival Rates ◽  
Eastern Cooperative Oncology Group ◽  
High Risk Patient ◽  
Prognostic Assessment ◽  
Graded Prognostic Assessment

433 Background: Spinal metastasis (SM) of hepatocellular carcinoma (HCC) is a crucial clinical problem. It shows heterogenous length of survival suggesting a need for predicting prognosis. In this study, we aimed to develop and propose a graded prognostic assessment of SM of HCC (HCC-SM GPA). Methods: We previously reported the outcomes of 192 HCC patients with SM who received radiotherapy from April 1992 to February 2012. Prognostic factors with significant effects on survival in that study were used to establish the HCC-SM GPA. Validation was performed using an independent cohort of 63 patients recruited from September 2011 to March 2016. Results: We developed HCC-SM GPA using the following factors: Eastern Cooperative Oncology Group performance status ( < 2: 0, > 3: 1 point), controlled primary HCC (Yes: 0, No: 2 points), and extrahepatic metastases other than bone (No: 0, Yes: 1 points). Patients were stratified into low (GPA = 0), intermediate (GPA = 1–2), and high risk (GPA = 3–4). When applied to the validation cohort, the HCC-SM GPA determined median survival durations of 13.6, 4.8, and 2.6 months and 1-year overall survival rates of 58.3%, 8.9%, and 7.3% for the low-, intermediate-, and high-risk patient groups, respectively (p < 0.001). Conclusions: Our newly proposed HCC-SM GPA successfully predicted survival outcome. This index might be a useful tool for making treatment decision.

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.

Survival after 131I-labeled lipiodol therapy for hepatocellular carcinoma

2014 ◽  
Vol 53 (02) ◽  
pp. 46-53 ◽  
Author(s):  
S. Ezziddin ◽  
K. Wilhelm ◽  
R. Fimmers ◽  
U. Spengler ◽  
H. Palmedo ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Palliative Therapy ◽  
International Normalized Ratio ◽  
Lesion Size ◽  
Disease Stage ◽  
Treatment Modalities ◽  
Class B

SummaryThis study investigated the efficacy of 131iod- ine-labeled lipiodol (1311-lipiodol) as a palliative therapy, evaluated overall survival (OS) across Barcelona Clinic Liver Cancer (BCLC) stages, and determined the main prognostic factors influencing OS in patients with hepatocellular carcinoma (HCC). Patients, methods: We retrospectively analyzed 57 (44 men; mean age, 65.7 years; mean activity per session, 1.6 GBq; mean cumulative activity in patients with >1 sessions, 3.9 GBq) HCC patients who underwent 1311-lipiodol therapy. A majority of patients exhibited Child-Pugh class B (53.6%) disease and a good Eastern Cooperative Oncology Group performance status (0-1; 72%). Multinodular disease was observed in 87.7% patients, bilobar disease in 73%, and portal vein occlusion (PVO) in 54%. Furthermore, 21.1% patients were staged as BCLC B and 59.6 % as BCLC C. All patients were followed until death. Results: The median OS was 6.4 months, which varied significantly with disease stage (median OS for BCLC A, B, C, and D was 29.4, 12.0, 4.6, and 2.7 months, respectively; p = 0.009); Child-Pugh score and class; presence of ascites, PVO, or extrahepatic disease; largest lesion size; favourable treatment response; international normalized ratio, baseline albumin and alpha-fetopro- tein levels. Patients with a Child-Pugh A liver disease had a longer OS. Conclusion: Currently, different treatment modalities for HCC include radioembolization, transarterial chemoemboliz- ation, and systemic therapy with sorafenib; however, 1311-lipiodol therapy remains a feasible alternative for patients without a favourable response to other therapies, particularly for patients with Child-Pugh A liver cirrhosis.

scholarly journals Safety and effectiveness of new embolization microspheres SCBRM for intermediate-stage hepatocellular carcinoma: A feasibility study

2020 ◽  
Author(s):  
Yi-Sheng Liu ◽  
Xi-Zhang Lin ◽  
Chiung-Yu Chen ◽  
Yen-Cheng Chiu ◽  
Jui-Wen Kang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Feasibility Study ◽  
Alanine Aminotransferase ◽  
Objective Response ◽  
Survival Rates ◽  
Intermediate Stage ◽  
Survival Times ◽  
Clinical Safety ◽  
Safety And Efficacy ◽  
Recommended Treatment

Transarterial chemoembolization (TACE) is currently the recommended treatment for hepatocellular carcinoma (HCC). However, long-term chemoembolization triggers the inflammatory response and may lead to postembolization syndrome (PES). Although several types of degradable microspheres have been developed to reduce drug toxicity and PES incidence, the clinical outcomes remain unsatisfactory. Previously, we have developed a new type of spherical, calibrated, biodegradable, radiopaque microspheres (SCBRM) and demonstrated their safety and efficacy in a pig model. Thus, the goal of this feasibility study was to determine the clinical safety and efficacy of the new SCBRM in intermediate-stage HCC patients. In this study, 12 intermediate-stage HCC patients underwent TACE using SCBRM with a calibrated size of 100–250 μm. The disease control rates at 1 month and 3 months after TACE-SCBRM treatment were 100% and 75.0%, respectively. The objective response rates at 1 month and 3 months after treatment were 66.7% and 58.3%, respectively. Very few adverse events were observed with one patient developing nausea. One day after the treatment, alanine aminotransferase, alanine aminotransferase, and total bilirubin levels were slightly elevated in the patients, but all returned to baseline on day 7. The median and mean overall survival times were 33 months (interquartile range, 12.8–42.0) and 29.2 ± 14.3 months, respectively. The 1-year and 2-year survival rates were 91.7% and 58.3%, respectively. In conclusion, TACE with the new SCBRM microspheres is clinically safe and effective, and it represents a promising approach in the management of intermediate-stage HCC.

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