Dr. Palta on the Clinical Implications of the NRG/RTOG 1112 Trial in HCC

Manisha Palta, MD, a radiation oncologist, an associate professor of Radiation Oncology, and a member of the Duke Cancer Institute, discusses the clinical implications of the phase 3 NRG/RTOG 1112 trial (NCT01730937) in patients with locally advanced hepatocellular carcinoma (HCC).

The NRG/RTOG 1112 trial evaluated stereotactic body radiation therapy (SBRT) plus sorafenib (Nexavar) compared with sorafenib alone in patients with locally advanced HCC. Findings presented at the 2023 Gastrointestinal Cancers Symposium showed that patients treated with SBRT/sorafenib experienced a median overall survival of 15.8 months (90% CI, 11.4-19.2) vs 12.3 months (90% CI, 10.6-14.3) with sorafenib alone (HR, 0.77; 90% CI, 0.59-1.01; 1-sided P = .55).

Additional findings demonstrated that SBRT/sorafenib elicited a median progression-free survival of 9.2 months (95% CI, 7.5-11.9) with SBRT/sorafenib vs 5.5 months (95% CI, 3.4-6.3) with sorafenib alone (HR, 0.55; 95% CI, 0.40-0.75; P = .0001). Time to progression with SBRT/sorafenib and sorafenib alone was 18.5 months and 9.5 months, respectively (HR, 0.69; 95% CI, 0.48-0.99; P = .034).

The data from NRG/RTOG 1112 trial support for the use of SBRT in patients with locally advanced HCC, Palta notes. Historically, yttrium-90 (Y-90) glass microspheres (TheraSphere) have been considered an acceptable alternative to SBRT; however, multiple randomized trials with similar patient populations to NRG/RTOG 1112 and comparator arms featuring systemic therapy have produced negative results, Palta explains.

The outcomes of NRG/RTOG 1112 should prompt investigators to think further about how locoregional therapies are integrated into care with agents such as immunotherapy, Palta continues. Although SBRT is suitable for patients unfit fit other therapies, more patients with HCC could benefit from shifting SBRT into earlier treatment settings. Future studies could continue to explore other areas where SBRT may fit into the treatment algorithm for HCC, Palta concludes.