scholarly journals Stereotactic body radiation therapy for small (≤5 cm) hepatocellular carcinoma not amenable to curative treatment: Results of a single-arm, phase II clinical trial

2020 ◽  
Vol 26 (4) ◽  
pp. 506-515 ◽  
Author(s):  
Sang Min Yoon ◽  
So Yeon Kim ◽  
Young-Suk Lim ◽  
Kang Mo Kim ◽  
Ju Hyun Shim ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Tertiary Care ◽  
Stereotactic Body Radiation ◽  
Small Hccs ◽  
Modified Recist

Background/Aims: Stereotactic body radiation therapy (SBRT) is used as an alternative ablative treatment in patients with hepatocellular carcinoma (HCC) not suitable for curative treatments. The purpose of this prospective study was to evaluate the long-term efficacy of SBRT for small (≤5 cm) HCCs.Methods: A phase II, single-arm clinical trial on SBRT for small HCCs was conducted at an academic tertiary care center. The planned SBRT dose was 45 Gy with a fraction size of 15-Gy over 3 consecutive days. The primary endpoint was 2-year local control rate. Radiologic responses were assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and the modified RECIST criteria.Results: Between 2013 and 2016, 50 patients (53 lesions) were enrolled, with a median follow-up period of 47.8 months (range, 2.9–70.6). Patients’ age ranged from 41 to 74 years, and 80% were male. Median tumor size was 1.3 cm (range, 0.7–3.1). The 2- and 5-year local control rates were 100% and 97.1%, respectively. The 5-year overall survival rate was 77.6%. Six months after SBRT, radiologic responses were evident in 44 lesions (83%) according to the RECIST criteria and 49 (92.4%) according to the modified RECIST criteria. None of the patients showed grade ≥3 adverse events.Conclusions: SBRT showed excellent results as an ablative treatment for patients with small HCCs while showing minimal toxicities. SBRT can be a good alternative for both curative and salvage intents in patients with HCCs that are unsuitable for curative treatments.

Excessive Toxicity When Treating Central Tumors in a Phase II Study of Stereotactic Body Radiation Therapy for Medically Inoperable Early-Stage Lung Cancer

2006 ◽  
Vol 24 (30) ◽  
pp. 4833-4839 ◽  
Author(s):  
Robert Timmerman ◽  
Ronald McGarry ◽  
Constantin Yiannoutsos ◽  
Lech Papiez ◽  
Kathy Tudor ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Early Stage ◽  
Stage I ◽  
Severe Toxicity ◽  
Stereotactic Body Radiation

PurposeSurgical resection is standard therapy in stage I non–small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population.Patients and MethodsEligible patients included clinically staged T1 or T2 (≤ 7 cm), N0, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks.ResultsAll 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60%. Kaplan-Meier local control at 2 years was 95%. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7%. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83% compared with only 54% for patients with central tumors.ConclusionHigh rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.

scholarly journals Protocol for an integrated phase II/III randomised controlled trial of transarterial chemotherapy and sorafenib with or without stereotactic body radiation therapy in patients with nonmetastatic unresectable hepatocellular carcinoma

2017 ◽  
Vol 4 (1) ◽  
pp. 31 ◽  
Author(s):  
Supriya Chopra ◽  
Nitin Shetty ◽  
Mahesh Goel ◽  
Reena Engineer ◽  
Karthick Rajamanickam ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Stereotactic Body Radiation Therapy ◽  
Controlled Trial ◽  
Phase Iii ◽  
High Dose ◽  
Stereotactic Body Radiation ◽  
Meta Analyses

<p class="abstract"><strong>Background:</strong> Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable disease. In the last decade results of randomized trials and subsequent meta-analyses established trans-arterial chemoembolization (TACE) as standard of care in patients with Barcelona clinic liver cancer (BCLC) stage B. However, there is clearly a need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent meta-analyses concluded that addition of radiation to TACE had 10-35% improvement in two-year overall survival, however as results of meta-analyses were based on small studies, the need for conducting a high quality randomized study was highlighted. The present study is designed to investigate the role of high dose stereotactic radiation as consolidation therapy after TACE in patients with non-metastatic unresectable HCC<span lang="EN-IN">. </span></p><p class="abstract"><strong>Methods:</strong> Patients diagnosed with non-metastatic unresectable HCC with BCLC stage B/A (medically inoperable) and Child-Pugh’s score A-B7 will be eligible. The trial will randomize patients into TACE alone arm or TACE followed by stereotactic body radiation therapy (SBRT). The primary aim is to compare in-field progression free survival (PFS) in phase II and overall survival in phase III between the control (TACE) and intervention arm (TACE+SBRT). The secondary aim is to compare cause specific survival, imaging response and quality of life in control and intervention arms<span lang="EN-IN">.</span></p><p class="abstract"><strong>Results:</strong> First analysis of the study has been planned when patient accrued under phase II study have completed 1 year follow up<span lang="EN-IN">.  </span></p><p class="abstract"><strong><span lang="NL"><br /></span></strong></p><p class="abstract"><strong><span lang="NL">Trail Registration: </span></strong><span lang="NL">Clinicaltrials.gov,NCT02794337</span></p>

Stereotactic body radiation therapy following transarterial chemoembolization for Child-Pugh A and B hepatocellular carcinoma.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 321-321
Author(s):  
Craig Joseph Baden ◽  
Benjamin Hinton ◽  
Rojymon Jacob
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiation Therapy ◽  
Local Control ◽  
Transarterial Chemoembolization ◽  
Stereotactic Body Radiation Therapy ◽  
Respiratory Gating ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Survival Times ◽  
Stereotactic Body Radiation

321 Background: Hepatocellular carcinoma (HCC) incidence continues to increase, but recent improvements in treatment of localized tumors have contributed to modest gains in survival rates. Though transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) are increasingly used in the management of unresectable HCC, outcomes data regarding the combination of these treatments is limited. Here we report institutional outcomes for patients with Child-Pugh A (CPA) and B HCC treated with TACE followed by SBRT. Methods: We completed an institutional retrospective review of all patients treated with combination TACE and SBRT between 2009 and 2013. After compiling dosimetry, toxicity, and outcomes data for each patient we calculated descriptive statistics for the cohort and determined local control (LC), distant liver control (DLC), progression free survival (PFS), and overall survival (OS) utilizing the Kaplan-Meier method. We also compared these disease-related outcomes between CPA and CPB groups with the Mantel-Cox test for equality. Results: Thirty-one patients with HCC, median age 65, were treated with TACE and SBRT and followed for a median 16.6 months (range: 6.2-50.8). Twenty-two patients had CPA disease and 9 CPB at the time of initial treatment. Following TACE and a median interval of 10.5 days (range: 4.4-25.6) patients underwent SBRT, the majority (23) with 45 Gy in 3 fractions. All but 3 patients were treated with respiratory gating, and all had cone-beam CT for image guidance. One and 2 year disease-related outcomes were as follows: LC 92.0 and 82.8%, DLC 81.5 and 61.0%, PFS 73.6 and 61.8%, OS 96.8 and 64.2%. There were no statistically significant differences between CPA or CPB patients with respect to any of these disease-related outcome measures. Median survival times for class A and B patients were 34.2 months (95% CI 12.3-56.1) and 27.2 months (14.9-39.5) respectively. Conclusions: The combination of TACE and SBRT is generally well tolerated, and results in very good local control in both CPA and CPB patients. Distant liver failure remains a major problem in these patients and requires further study.

Early stage hepatocellular carcinoma treated with stereotactic body radiation therapy: A pooled analysis from two North American institutions.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 350-350 ◽  
Author(s):  
Ashwathy Susan Mathew ◽  
Eshetu G. Atenafu ◽  
Dawn Owen ◽  
Chris Maurino ◽  
Anthony M. Brade ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Local Control ◽  
North American ◽  
Stereotactic Body Radiation Therapy ◽  
Early Stage ◽  
Pooled Analysis ◽  
Stereotactic Body Radiation ◽  
Grade 3

350 Background: To report outcomes of pooled data from patients with early stage hepatocellular carcinoma (HCC) treated with stereotactic body radiation therapy (SBRT) at two North American Institutions. Methods: An IRB approved collaborative review of patients with HCC treated with radical intent SBRT was conducted. Inclusion criteria included patients with Stage I-IIIA HCC (UICC/AJCC 7th Ed.) treated with SBRT (≥ 4.5 Gy/ fraction) from June 2003 until Dec 2016. Patients who were treated with SBRT were ineligible for resection, percutaneous ablative or hepatic intravascular therapies. Patients with vascular invasion and those treated with palliative intent (e.g. HCC rupture) were excluded. Overall survival, local control and toxicity of treatment were reviewed retrospectively. Results: Of 310 eligible patients, 23% were Child-Pugh (CP) class B/C (21%/2%), and 40% had failed prior liver directed therapies. The median HCC diameter was 2.4 cm (range 0.5-18.1 cm), and the median prescribed dose was 39 Gray (Gy) in 5 fractions (range: 14 - 60 Gy in 2-6 fractions). Median BED was 78.75 Gy (Range: 23.8-180.0 Gy). 8.4% of patients underwent liver transplant after SBRT. Local control at 1, 3 and 5 years was 91.5%, 82.6% and 82.6%. On multivariable analysis (MVA), the use of breath-hold motion management, but not T stage, size or dose, was significantly associated with local control (p = 0.0098). The 1, 3, and 5 year overall survival (OS) was 77.3%, 37.9% and 23.5%. Factors associated with improved OS on MVA included baseline CP A score (HR = 0.58, p < 0.0045), AFP < 10 µg/L (HR = 0.66, p = 0.0094), and transplant post SBRT (HR = 0.05, p < 0.0001). The median survival of CP A vs. B/C patients was 30.3 and 17.6 months respectively. CTCAE (v4.0) grade 3 or higher luminal gastrointestinal organ toxicity occurred in 2.5% of patients, while a decline in CP score ≥ 2 points was seen in 16.7% of patients at 3 months post SBRT. Grade 3 and above elevated liver enzymes were seen in 12.6% and 8.1% of patients at baseline and at 3 months post SBRT. Conclusions: Similar to Asian series, this North American pooled analysis found high sustained local control and excellent survival in patients with early stage HCC treated with SBRT.

scholarly journals Helical IMRT-Based Stereotactic Body Radiation Therapy Using an Abdominal Compression Technique and Modified Fractionation Regimen for Small Hepatocellular Carcinoma

2020 ◽  
Vol 19 ◽  
pp. 153303382093700
Author(s):  
Yi-Xing Chen ◽  
Yuan Zhuang ◽  
Ping Yang ◽  
Jia Fan ◽  
Jian Zhou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Abdominal Compression ◽  
Compression Technique ◽  
Stereotactic Body Radiation ◽  
Radiation Induced ◽  
Fractionation Regimen

Purpose: To assess the efficacy and safety of stereotactic body radiation therapy using an abdominal compression technique and modified fractionation regimen (5-10 fractions) in patients with small-sized hepatocellular carcinoma. Methods: A total of 101 patients with small-sized hepatocellular carcinoma treated with stereotactic body radiation therapy using an abdominal compression technique and modified fractionation regimen were registered between June 2011 and June 2019 in our hospital. A total dose of 48 to 60 Gy was applied over 5 to 14 consecutive days. Liver motion was controlled by abdominal compression, and a helical intensity-modified radiation therapy-based stereotactic body radiation therapy administrated in tomotherapy platform. Results: The median follow-up period was 23.2 months (range: 4.1-99.2 months). Complete response and partial response were observed in 63 (62.4%) patients and in 24 (23.8%) patients, respectively. At the time of our analysis, the 1-, 3-, and 5-year local control rates after stereotactic body radiation therapy were 96.1%, 89.0%, and 89.0%, respectively. However, logistic regression analysis revealed no correlation between the biologically effective dose and 3-year local control rates. The 1-, 3-, and 5-year overall survival rates were 96.9%, 69.0%, and 64.3%, respectively. For patients who were treatment-naive, the 1-, 3-, and 5-year overall survival were 96.3%, 82.0%, and 82.0%, respectively. No patients experienced classic radiation-induced liver disease or nonclassic radiation-induced liver disease after stereotactic body radiation therapy completion. Conclusions: When using an abdominal compression technique and modified fractionation regimen (5-10 fractions) based on helical intensity-modified radiation therapy, stereotactic body radiation therapy led to a lower toxicity and comparative rate of local control and overall survival for patients who with small-sized hepatocellular carcinoma.

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