A randomized phase II feasibility 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

Beth Isreal/Lahey Health, Burlington, MA

Francis W. Nugent III, Klaudia Hunter , Chris Molgaard , Amir Qamar , Krishna Gunturu , Keith E. Stuart , Frederic Gordon , Sebastian Flacke

Organizations

Beth Isreal/Lahey Health, Burlington, MA, Tufts University/ Lahey Hospital and Medical Center, Burlington, MA, Lahey Hospital and Medical Center, Burlington, MA, Beth Isreal Lahey Health, Burlington, MA

Research Funding

Other Foundation
Wise Grant, Pharmaceutical/Biotech Company

Background: For HCC pts undergoing LT, loco-regional treatment as a "bridge" is standard. The best bridging modality is unclear. SBRT is safe and effective when used in pts with advanced HCC. We prospectively compared SBRT to TACE as a bridge for HCC pts undergoing LT. Methods: From 9/2014-10/2019, 60 pts within Milan Criteria with CTP Class A/B8 cirrhosis were consented. 54 pts were randomized to TACE vs. SBRT. TACE pts (n =30) were scheduled to receive 2 treatments one month apart utilizing DEBDOX beads. TACE pts were hospitalized after each TACE. Pts receiving SBRT (n =24) received a median total dose of 45Gy delivered over 5 fractions using fiducials. Mean liver dose, Veff, and NTCP determined prescription dose. Pts were assessed by using mRECIST criteria at 2 months and every 3 months thereafter until LT or death. Toxicity and QOL 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. The 1° endpoint was time to recurrent or residual dz. Secondary endpoints were toxicity, pathologic response, radiologic response, number of subsequent treatments, cost, and QOL. 50 pts are evaluable for review. Results: See table. Conclusions: For early stage HCC patients with CTP Class A/B liver cirrhosis, SBRT appears as effective as TACE at controlling HCC prior to LT, may engender less toxicity, and eliminates the need for hospitalization. A larger multi-center trial is ongoing. Clinical trial information: NCT02182687.

DemographicsSBRT (n=21)TACE (n=29)
Med. CTP score6.06.0
Stage I HCC81.0%86.2%
Med. Time to 1° endpoint (mos)10.4
(95%CI: 4.2 to 12.0)
9.2
(95%CI: 5.3 to 11.0)
QOLSBRT
(n=14)
TACE
(n=26)
ΔPain sum score0.7+/-4.53.9+/-7.4
ΔWML score0.4+/-5.84.1+/-8.2
SF36v2:
ΔPCS-3.7+/-5.2-2.0=/-4.8
ΔMCS3.3+/-5.7-1.5+/-4.9

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Hepatobiliary Cancer

Clinical Trial Registration Number

NCT02182687

Citation

J Clin Oncol 38: 2020 (suppl; abstr 4586)

DOI

10.1200/JCO.2020.38.15_suppl.4586

Abstract #

4586

Poster Bd #

194

Abstract Disclosures