A randomized phase II study of individualized stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) as a bridge to transplant in hepatocellular carcinoma (HCC).

Authors

null

Francis Warren Nugent

Lahey Hospital and Medical Center, Concord, MA

Francis Warren Nugent , Krishna Gunturu , Keith E. Stuart , Sebastian Flacke , Chris Molgaard , Klaudia Hunter , Amir Qamar , Shams Iqbal , Frederick Gordon , Kari Galuski , Erin Hartnett

Organizations

Lahey Hospital and Medical Center, Concord, MA, Lahey Hospital and Medical Center, Burlington, MA, Lahey Clinic Medical Center, Burlington, MA, Lahey Clinic Medical Center, Tufts University School of Medicine, Burlington, MA

Research Funding

Pharmaceutical/Biotech Company

Background: For HCC pts undergoing LT, local treatment as a "bridge" is standard to decrease likelihood of tumor progression. The most common treatment is TACE, but the safest and most effective bridging modality is unclear. Recently, SBRT has been shown to be both safe and effective when used in pts with locally advanced HCC. We prospectively compare SBRT to TACE as a bridge for HCC pts undergoing LT. Methods: 60 pts are planned for accrual. Pts with C-P < 9 and HCC within Milan Criteria were randomized between two arms. TACE pts received 2 treatments one month apart using DEBDOX beads. TACE pts were hospitalized after each treatment. Pts randomized to SBRT, after fiducial placement, received a median total dose of 45 Gy delivered over 5 fractions. Mean liver dose, Veff, and NTCP were utilized to determine the prescription dose. Pts were assessed by imaging using mRECIST criteria at 2 months and every 3 months thereafter until LT or death. Toxicity and quality of life (QOL) were assessed before treatment, during treatment, 2 weeks post-treatment, and then every 3 months using the PIQ-6 Pain Impact Questionnaire and the SF-36v2 Health Survey. Primary endpoint was need for retreatment of the previously treated lesion(s). Secondary endpoints include toxicity, pathologic response, radiologic response, QOL, and cost. Results: From 9/2014-1/17, 33 pts within Milan Criteria with C-P Class A/B cirrhosis were randomized to TACE (n = 18) vs. SBRT (15). Data on evaluable pts is summarized in the table below. Conclusions: For HCC patients with C-P Class A/B liver cirrhosis, SBRT appears at least equally effective as TACE as a bridge to liver transplantation. SBRT may engender less toxicity, better maintain QOL, and eliminate the need for hospitalization. An update along with a full cost analysis will be presented in June. Clinical trial information: nct02182687

SBRT = 13TACE = 17
Age63.360.6
% Stage I85%88%
C-P Score5.75.8
Median Follow Up237 Days154 Days
Toxicity Events (G2-4)23%65%
Reduction in QOL-0.65 (+/- 7.4)-2.65 (+/- 4.4)
% Recurrence0%24%
Residual Dz on Explant2/64/7

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Hepatobiliary Cancer

Clinical Trial Registration Number

nct02182687

Citation

J Clin Oncol 35, 2017 (suppl; abstr e15677)

DOI

10.1200/JCO.2017.35.15_suppl.e15677

Abstract #

e15677

Abstract Disclosures