scholarly journals Stereotactic Body Radiation Therapy after Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: The STRONG Trial, a Phase I Safety and Feasibility Study

Cancers ◽  
2021 ◽  
Vol 13 (16) ◽  
pp. 3991
Author(s):  
Rogier Baak ◽  
François E. J. A. Willemssen ◽  
Yvette van Norden ◽  
Ferry A. L. M. Eskens ◽  
Maaike T. W. Milder ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Local Control Rate ◽  
Stereotactic Body Radiation ◽  
Common Grade ◽  
Grade 3

Background: In unresectable pCCA, the standard of care is palliative chemotherapy. We investigated the feasibility and safety of adding stereotactic body radiation therapy (SBRT) after chemotherapy. Methods: Patients with unresectable pCCA, stage T1-T4N0-N1M0, ECOG 0-1, having finished 6–8 cycles of cisplatin and gemcitabine without disease progression were eligible. SBRT was planned in 15 fractions of 3.0–4.5 Gy. The primary endpoints were feasibility (defined as completing SBRT as planned) and toxicity, evaluated within 3 months after SBRT (CTCAE v4.03). A conventional “3 + 3” design was used, corresponding to a sample size of 6 patients. Dose-limiting toxicity (DLT) was defined as grade ≥ 4 hepatobiliary or grade ≥ 3 gastrointestinal toxicity. The secondary endpoints, measured from the start of radiotherapy, were local control, progression-free survival, overall survival, and quality of life (QoL). ClinicalTrials.gov identifier: NCT03307538. Results: Six patients were enrolled between November 2017 and March 2020. SBRT was delivered as planned. All patients were treated with 60Gy (15 × 4.0Gy). No SBRT-related DLT was observed. The most common grade ≥ 3 toxicity was cholangitis (n = 5). The median follow-up was 14 months. The 12-month local control rate was 80%. We observed no substantial changes in QoL. Conclusion: In patients with unresectable pCCA with stable disease after palliative chemotherapy, adding SBRT is feasible and safe. The observed local control merits an additional evaluation of effectiveness.

scholarly journals Efficacy and Prognostic Factors of Trans-Arterial Chemoembolization Combined With Stereotactic Body Radiation Therapy for BCLC Stage B Hepatocellular Carcinoma

2021 ◽  
Vol 11 ◽  
Author(s):  
Changchen Jiang ◽  
Shenghua Jing ◽  
Han Zhou ◽  
Aomei Li ◽  
Xiangnan Qiu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiation Therapy ◽  
Prognostic Factors ◽  
Stereotactic Body Radiation Therapy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Stereotactic Body Radiation ◽  
Grade 3 ◽  
Arterial Chemoembolization

PurposeThis study aimed to evaluate the efficacy and safety of trans-arterial chemoembolization (TACE) followed by stereotactic body radiation therapy (SBRT) in treating Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) not amenable to resection and radiofrequency ablation (RFA).MethodsFrom February 2012 to January 2017, a total of 57 BCLC stage B HCC patients who were unsuitable candidates for resection and RFA treated with TACE combined with CyberKnife SBRT were included in this retrospective study. Patients underwent TACE for a median of two times (1–5 times) before SBRT. SBRT prescription doses ranged from 30 Gy to 50 Gy in 3–5 fractions.ResultsThe median follow-up time was 42 months. The objective response rate (CR + PR) was 85.9%, and the disease control rate (CR + PR + SD) was 96.5%. The local control (LC) rates were 91.1% and 84.3% at 1 and 2 years, respectively. The 1-, 2-, 3-year overall survival (OS) and the median survival time were 73.2%, 51.4%, 32.4% and 26.6 months, respectively. The 1-, 2-, and 3-year progression-free survival (PFS) were 34.2%, 21.6%, and 9%, respectively, with a median PFS time of 9.7 months. A subgroup analysis was conducted in 32 patients with AFP ≥ 200 ng/ml before TACE. OS was significantly prolonged in those with AFP that decreased by more than 75% than those with AFP that decreased by less than 75% (P = 0.018) after SBRT. The treatment was well tolerated with only one patient (1.8%) developed grade 3 gastrointestinal toxicity, and another patient developed non-classical RILD. In multivariate analysis, tumor length ≥ 10 cm and AFP ≥ 200 ng/ml were independent poor prognostic factors for OS.ConclusionThe combination of TACE and Cyberknife SBRT showed optimal efficacy with acceptable toxicity for BCLC stage B HCC.

Stereotactic body radiation therapy for pancreatic cancer: Single institutional experience.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 328-328 ◽  
Author(s):  
Shalini Moningi ◽  
Siva P. Raman ◽  
Avani Satish Dholakia ◽  
Amy Hacker-Prietz ◽  
Timothy M. Pawlik ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Acute Toxicity ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Stereotactic Body Radiation ◽  
Early Results ◽  
Grade 3

328 Background: Stereotactic Body Radiation Therapy (SBRT) is emerging as a possible standard treatment for pancreatic cancer; however, there is limited data to support its efficacy. This study reviews our institution’s experience using SBRT in the treatment of pancreatic cancer (PCA). Methods: Charts of all PCA patients receiving SBRT from January 2010 to June 2013 were retrospectively reviewed. The primary end points were overall survival (OS) and tumor response assessed by RECIST criteria. 95% of the PTV (GTV + 2-3 mm) received a total dose of 20-33 Gy in five fractions (4-6.6 Gy/fraction), with up to 20% heterogeneity allowed. Pre- and post-SBRT chemotherapy regimens included gemcitabine, cisplatin, FOLFIRINOX, 5-FU or paclitaxel. Results: 84 patients received SBRT, with a median follow-up time of 15.3 months. Median age was 66.5 years, 57.1% were male and 65.5% had head tumors. 66 patients received definitive SBRT for locally advanced or borderline resectable PCA, 4 patients were treated with adjuvant SBRT, and 14 received SBRT for treatment of recurrent disease. Median OS from the date of diagnosis for patients receiving definitive radiation was 17.8 mos (95% CI 14.9-20.9).For recurrent patients the median OS from first day of SBRT was 11.8 mos (95%CI 8.3-15.3). In the definitive SBRT group, among patients who were alive and had follow-up scans, the 6 and 12 month local control rate (stable or partial response) based on RECIST criteria was 84.6% and 81.8%, respectively. Five patients underwent surgery following SBRT and all had negative resection margins. Acute toxicity was minimal with most experiencing grade 1 or 2 fatigue and no grade 3/4 acute toxicity. Late grade 3/4 GI toxicity was seen in 5% (4/84) and 1 patient had a grade 5 GI bleed due to direct tumor invasion into the duodenum. Conclusions: Our early results using SBRT in the definitive and recurrent settings show favorable local control, toxicity, and survival when compared to historical outcomes using chemoradiation. Acute and late toxicity was minimal however the optimal dose and fractionation as well as normal tissue dose constraints need to be determined. Integration of SBRT with more aggressive chemotherapy may result in improved outcomes in patients with PCA.

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.

Stereotactic body radiotherapy response and local control rates for hepatic oligometastases.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3546-3546
Author(s):  
Ben Goodman ◽  
Cynthia S Johnson ◽  
Netsanet Gebregziabher ◽  
Mary A. Maluccio ◽  
Paul R. Helft ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Radiation Therapy ◽  
Cancer Patients ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Local Control Rate ◽  
Primary Cancer ◽  
Stereotactic Body Radiation ◽  
The Mean ◽  
Colorectal Cancer Patients

3546 Background: Stereotactic body radiation therapy (SBRT) is a non-invasive, effective technique in the treatment of hepatic oligometastases from solid tumors. We present response and local control rates from our single institution experience. Methods: We treated 79 metastatic liver lesions from 64 different patients using stereotactic body radiation therapy. One colorectal cancer patient was treated three times and four patients were treated twice. Among the 79 metastatic liver lesions treated, 85% had prior chemotherapy. The primary cancer site included: Colorectal 66%, Non-colorectal GI 14%, Breast 6%, Ovarian 5%, NSCLC 3%, and other 6%. The mean GTV size was 37.3 (cc). The mean GTV diameter was 3.1 (cm). The median total dose was 54 (Gy) with the minimum and maximum total dose being 30 and 60 (Gy). Results: The overall local control rate was 94.2%, with estimates at 12, 24, 36, and 48 months being 96.1%, 87.9%, 87.9% and 87.9% following SBRT treatment. When comparing colorectal cancer patients vs all other primary cancer sites, the one year local control rate was 93.4% and 100%. The two and three year local control rates for colorectal cancer vs other primary cancer sites were 84.9% vs 90.9%. Best response was examined as a 4 level response (CR,PR,SD,PD) per the RECIST criteria. Overall, 67% of patients had a response, and less than 3% of patients had progression with SBRT treatment. For colorectal cancer patients, 79% had a response to treatment. Only 21% of colorectal cancer patients did not respond, however, the majority of these patients still had stable disease following treatment. Non-colorectal primary site cancers had a response in 50% of the lesions following SBRT treatment. The remaining 50% of non-colorectal primary cancers were stable following SBRT treatment and none progressed. The median dose for CR, PR, or SD was 54 Gy. The median dose for patients with progressive disease was less than 50 Gy. The observed CTC toxicities were limited with mostly grade 1-2 toxicity and only two grade 4 and one grade 5 toxicity. Conclusions: Stereotactic body radiation therapy is an effective treatment option for patients with hepatic oligometastases with a limited toxicity profile.

scholarly journals Upfront Chemotherapy Followed by Stereotactic Body Radiation Therapy with or without Surgery in Older Patients with Localized Pancreatic Cancer: A Single Institution Experience and Review of the Literature

2022 ◽  
Vol 29 (1) ◽  
pp. 308-320
Author(s):  
Abhinav V. Reddy ◽  
Shuchi Sehgal ◽  
Colin S. Hill ◽  
Lei Zheng ◽  
Jin He ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Clinical Outcomes ◽  
Older Patients ◽  
Stereotactic Body Radiation Therapy ◽  
Progression Free Survival ◽  
Radiation Toxicity ◽  
Free Survival ◽  
Stereotactic Body Radiation ◽  
Resection Status

Objective: To report on clinical outcomes and toxicity in older (age ≥ 70 years) patients with localized pancreatic cancer treated with upfront chemotherapy followed by stereotactic body radiation therapy (SBRT) with or without surgery. Methods: Endpoints included overall survival (OS), local progression-free survival (LPFS), distant metastasis-free survival (DMFS), progression-free survival (PFS), and toxicity. Results: A total of 57 older patients were included in the study. Median OS was 19.6 months, with six-month, one-year, and two-year OS rates of 83.4, 66.5, and 42.4%. On MVA, resection status (HR: 0.30, 95% CI 0.12–0.91, p = 0.031) was associated with OS. Patients with surgically resected tumors had improved median OS (29.1 vs. 7.0 months, p < 0.001). On MVA, resection status (HR: 0.40, 95% CI 0.17–0.93, p = 0.034) was also associated with PFS. Patients with surgically resected tumors had improved median PFS (12.9 vs. 1.6 months, p < 0.001). There were 3/57 cases (5.3%) of late grade 3 radiation toxicity and 2/38 cases (5.3%) of Clavien-Dindo grade 3b toxicity in those who underwent resection. Conclusion: Multimodality therapy involving SBRT is safe and feasible in older patients with localized pancreatic cancer. Surgical resection was associated with improved clinical outcomes. As such, older patients who complete chemotherapy should not be excluded from aggressive local therapy when possible.

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.

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