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- Title
Stereotactic Body Radiotherapy and Liver Transplant for Liver Cancer: A Nonrandomized Controlled Trial.
- Authors
Lee, Victor Ho-Fun; Vardhanabhuti, Varut; Wong, Tiffany Cho-Lam; Lam, Ka-On; Choi, Horace Cheuk-Wai; Chiu, Keith Wan-Hang; Ho, Patty Pui-Ying; Leung, Dennis Kwok-Chuen; Szeto, Matthew Ho-Man; Choi, Kwok-Fung; Chan, See-Ching; Leung, To-Wai; Khong, Pek-Lan; Lo, Chung-Mau
- Abstract
Key Points: Question: Is bridging stereotactic body radiotherapy (SBRT) before deceased donor liver transplant associated with favorable outcomes among patients with unresectable hepatocellular carcinoma (HCC)? Findings: In this phase 2 nonrandomized controlled trial of 32 patients with unresectable HCC, an objective response rate of 87.5% after SBRT was observed for lesions as determined by dual-tracer positron emission tomography and magnetic resonance imaging, with significant factors associated with progression-free survival and overall survival identified. Of 20 patients who received a deceased donor liver transplant, 15 patients had pathologic complete response in the liver explants. Meaning: This study suggests that SBRT could be considered as an effective and safe bridging therapy to deceased donor liver transplant for previously untreated unresectable HCC within UCSF criteria under the surveillance of the most contemporary and accurate imaging modalities. Importance: Whether stereotactic body radiotherapy (SBRT) as a bridge to liver transplant for hepatocellular carcinoma (HCC) is effective and safe is still unknown. Objective: To investigate the feasibility of SBRT before deceased donor liver transplant (DDLT) for previously untreated unresectable HCC. Design, Setting, and Participants: In this phase 2 nonrandomized controlled trial conducted between June 1, 2015, and October 18, 2019, 32 eligible patients within UCSF (University of California, San Francisco) criteria underwent dual-tracer (18F-fluorodeoxyglucose and 11C-acetate [ACC]) positron emission tomography with computed tomography (PET-CT) and magnetic resonance imaging (MRI) with gadoxetate followed by SBRT of 35 to 50 Gy in 5 fractions, and the same imaging afterward while awaiting DDLT. Statistical analysis was performed on an intention-to-treat basis between October 1 and 31, 2023. Intervention: Patients received SBRT followed by DDLT when matched deceased donor grafts were available. Main Outcomes and Measures: Coprimary end points were progression-free survival (PFS) and objective response rates (ORRs) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), modified RECIST (mRECIST), and PET Response Criteria in Solid Tumors (PERCIST). Secondary end points were local control rate, overall survival (OS), and safety. Results: A total of 32 patients (median age, 59 years [IQR, 54-63 years]; 22 men [68.8%]) with 56 lesions received SBRT. After a median follow-up of 74.6 months (IQR, 40.1-102.9 months), the median PFS was 17.6 months (95% CI, 6.6-28.6 months), and the median OS was 60.5 months (95% CI, 29.7-91.2 months). The 5-year PFS was 39.9% (95% CI, 19.9%-59.9%), and the 5-year OS was 51.3% (95% CI, 31.7%-70.9%). In terms of number of patients, ORRs were 62.5% ([n = 20] 95% CI, 54.2%-68.7%) by RECIST 1.1, 71.9% ([n = 23] 95% CI, 63.7%-79.0%) by mRECIST, and 78.1% ([n = 25] 95% CI, 73.2%-86.7%) by PERCIST. In terms of number of lesions, ORRs were 75.0% ([n = 42] 95% CI, 61.6%-80.8%) by RECIST 1.1, 83.9% ([n = 47] 95% CI, 74.7%-90.6%) by mRECIST, and 87.5% ([n = 49] 95% CI, 81.3%-98.6%) by PERCIST. Twenty patients with 36 lesions received DDLT, of whom 15 patients (75.0%) with 21 lesions (58.3%) exhibited pathologic complete response. Multivariable analyses revealed that pretreatment metabolic tumor volume (MTV) based on ACC (hazard ratio [HR], 1.06 [95% CI, 1.01-1.10]; P =.01) and complete metabolic response (CMR) by PERCIST (HR, 0.31 [95% CI, 0.10-0.96]; P =.04) were associated with PFS, while pretreatment MTV based on ACC (HR, 1.07 [95% CI, 1.03-1.16]; P =.01), total lesion activity based on ACC (HR, 1.01 [95% CI, 1.00-1.02]; P =.02), and CMR by PERCIST (HR, 0.21 [95% CI, 0.07-0.73]; P =.01) were associated with OS. Toxic effects associated with SBRT were reported for 9 patients (28.1%), with 1 grade 3 event. Conclusions and Relevance: This phase 2 nonrandomized controlled trial demonstrated promising survival and safety outcomes of SBRT before DDLT for unresectable HCC. Future randomized clinical trials are warranted. This phase 2 nonrandomized controlled trial investigates the feasibility of bridging stereotactic body radiotherapy before deceased donor liver transplant for previously untreated unresectable hepatocellular carcinoma.
- Subjects
LIVER tumors; PATIENT safety; CANCER relapse; DATA analysis; RESEARCH funding; PILOT projects; COMPUTED tomography; RADIOSURGERY; POSITRON emission tomography; MAGNETIC resonance imaging; DESCRIPTIVE statistics; MULTIVARIATE analysis; MANN Whitney U Test; KAPLAN-Meier estimator; STATISTICS; RADIATION doses; PROGRESSION-free survival; CONFIDENCE intervals; HEALTH equity; DATA analysis software; LIVER transplantation; OVERALL survival; CONTRAST media; PROPORTIONAL hazards models; REGRESSION analysis
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2415998
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.15998