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
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
Variable | SBRT (N = 13) | TACE (N = 16) |
---|---|---|
C-P Score | 5.91 | 5.73 |
Cancer Stage 1 | 83.3% | 93.3% |
Side Effect (Any Grade) | (completion of SBRT) | (following TACE #1) |
Fatigue | 72.7% | 93.3% |
Pain | 72.7% | 86.7% |
nausea | 36.36% | 46.7% |
anorexia | 0% | 33.3% |
Hospital Days | ||
1 | 100.0% | 13.3% |
2 | 0 % | 86.7% |
B. TIME TO RETREATMENT | ||
---|---|---|
Variable | SBRT | TACE |
# randomized | 13 | 16 |
# w/ fu info (n = 4 active excluded) | 11 | 14 |
# pts retreated | 0 | 4 |
Kaplan-Meier est. of % re-tx | ||
…..at 3 mo | 0.0% | 8.3% |
…..at 6mo | 0.0% | 18.5% |
…..at 9 mo | 0.0% | 38.9% |
…..at 12mo | 0.0% | 38.9% |
Median # months to retreat | not estimatable | not estimatable |
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Abstract Disclosures
2020 ASCO Virtual Scientific Program
First Author: Francis W. Nugent III
2024 ASCO Genitourinary Cancers Symposium
First Author: John Nikitas
2017 ASCO Annual Meeting
First Author: Francis Warren Nugent
2023 ASCO Annual Meeting
First Author: Chi Leung Chiang