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

Authors

null

Francis W. Nugent III

Lahey Hospital and Medcl Ctr, Burlington, MA

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

Organizations

Lahey Hospital and Medcl Ctr, Burlington, MA, Lahey Hospital and Medical Center, Burlington, MA, Lahey Clinic Medcl Ctr, Burlington, MA, Lahey Clinic Medical Center, Tufts University School of Medicine, Burlington, MA, Univ of Michigan, Ann Arbor, MI

Research Funding

Other Foundation

Background: For HCC pts undergoing LT, local regional treatment as a "bridge" is standard to decrease tumor progression. The most common treatment is TACE, but the best 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 planned for accrual. From 9/2014-9/2016, 29 pts within Milan Criteria with C-P Class A/B cirrhosis were randomized to TACE vs. SBRT. TACE pts received 2 treatments one month apart utilizing DEBDOX beads (n = 15). TACE pts were hospitalized after each TACE. Pts receiving SBRT (n = 12) received a median total dose of 45Gy delivered over 5 fractions using fiducials. 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 were assessed before treatment, during treatment, two weeks post-treatment, and then every three months using the PIQ-6 Pain Impact Questionnaire and the SF-36v2 Health Survey. Primary endpoint was time to retreatment of treated lesion(s). Secondary endpoints include toxicity, pathologic response, radiologic response, number of subsequent treatments, cost, and QOL. Results: A. Demographics/Toxicity. Conclusions: For HCC patients with C-P Class A/B liver cirrhosis, SBRT appears equally effective to TACE as a bridge to liver transplantation, may engender less toxicity, and eliminates hospitalizations. Clinical trial information: NCT02182687

VariableSBRT (N = 13)TACE (N = 16)
C-P Score5.915.73
Cancer Stage 183.3%93.3%
Side Effect (Any Grade)(completion of SBRT)(following TACE #1)
Fatigue72.7%93.3%
Pain72.7%86.7%
nausea36.36%46.7%
anorexia0%33.3%
Hospital Days
1100.0%13.3%
20 %86.7%
B. TIME TO RETREATMENT
VariableSBRTTACE
# randomized1316
# w/ fu info (n = 4 active excluded)1114
# pts retreated04
Kaplan-Meier est. of % re-tx
…..at 3 mo0.0%8.3%
…..at 6mo0.0%18.5%
…..at 9 mo0.0%38.9%
…..at 12mo0.0%38.9%
Median # months to retreatnot estimatablenot estimatable

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Abstract Details

Meeting

2017 Gastrointestinal Cancers Symposium

Session Type

General Session

Session Title

General Session 5: Hepatobiliary Cancers—New Frontiers of Treatment

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT02182687

Citation

J Clin Oncol 35, 2017 (suppl 4S; abstract 223)

DOI

10.1200/JCO.2017.35.4_suppl.223

Abstract #

223

Abstract Disclosures