Current outcomes from the Part III NRG-RTOG 1112 medical examine confirmed that the addition of stereotactic physique radiotherapy (SBRT) to systemic remedy with sorafenib considerably improved progression-free survival (PFS) and time-to-progression in sufferers with domestically superior hepatocellular carcinoma (HCC) when in comparison with sorafenib alone. Moreover, the addition of SBRT to sorafenib was related to clinically essential enhancements in general survival (OS) for sufferers with domestically superior HCC. These outcomes have been not too long ago revealed in JAMA Oncology. The trial was funded by the Nationwide Most cancers Institute, Nationwide Institutes of Well being.
Usually, sufferers handled with systemic remedy for domestically superior hepatocellular carcinoma recur inside the liver following remedy. Invasion of HCC into the massive hepatic vessels, known as macrovascular invasion (MVI), is related to elevated danger of metastases and decrease survival. This inhabitants has an unmet want to higher management most cancers and enhance survival outcomes. The improved outcomes noticed with the addition of SBRT, notably in sufferers with MVI, are in line with prior smaller research and supply proof for the efficacy of SBRT in sufferers with HCC. These outcomes additionally present robust rationale for randomized research of SBRT mixed with immunotherapy for sufferers with HCC and MVI, that are deliberate.”
Laura A. Dawson MD, Professor and Chair of the Division of Radiation Oncology, Temerty Drugs, College of Toronto, radiation oncologist on the Princess Margaret Most cancers Centre, College Well being Community, and the lead writer of the NRG-RTOG 1112 manuscript
NRG-RTOG 1112 accrued 177 eligible sufferers and stratified sufferers by efficiency standing, liver perform, diploma of metastases, and diploma of MVI. MVI was seen in 131 out 177 (74%) of sufferers accrued. Sufferers have been randomly assigned to obtain both SBRT with sorafenib or sorafenib alone. Sufferers receiving SBRT obtained 27.5 to 50 Gy in 5 fractions. The first endpoint of this examine was OS; secondary endpoints included PFS, opposed occasions, and high quality of life.
The median OS was 12.3 months on the sorafenib alone remedy arm (90% CI 10.6–14.3) versus 15.8 months on the sorafenib with SBRT remedy arm (90% CI 11.4–19.2) (hazard ratio [HR] 0.77, 90% CI 0.59–1.01, 1-sided p=0.055).
Moreover, median PFS was improved from 5.5 months on the sorafenib alone remedy arm (95% CI 3.4–6.3) to 9.2 months on the SBRT with sorafenib remedy arm (7.5–11.9) (HR, 0.55, 95% CI 0.40–0.75, 2-sided p<0.001). Grade 3 or larger opposed occasions have been seen in 42% of the sufferers handled with sorafenib and 47% for the sufferers handled with SBRT and sorafenib (p=0.52). Two treatment-related deaths occurred within the sorafenib alone remedy arm versus one treatment-related demise within the SBRT and sorafenib remedy arm.
High quality of life at 6 months was additionally improved with the addition of SRBT. High quality of life enchancment was seen in 10% of sufferers who have been on the sorafenib alone remedy arm versus 35% of sufferers on the SBRT with sorafenib remedy arm.
This examine was funded by U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), and U24CA180803 (IROC) from the Nationwide Most cancers Institute (NCI), a part of the Nationwide Institutes of Well being.
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Journal reference:
Dawson, L. A., et al. (2024). Stereotactic Physique Radiotherapy vs Sorafenib Alone in Hepatocellular Carcinoma. JAMA Oncology. doi.org/10.1001/jamaoncol.2024.5403.