NRG/RTOG 1112 Study Evaluates SBRT Plus Sorafenib for Hepatocellular Carcinoma

Laura A. Dawson, MD, FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, discusses the NRG/RTOG 1112 study (NCT01730937) for patients with hepatocellular carcinoma (HCC) who were given stereotactic body radiation therapy (SBRT) followed by sorafenib (Nexavar) compared with sorafenib alone.

The NRG/RTOG 1112 study randomized patients with HCC to receive sorafenib 400 mg orally, or between 27.5-50 Gy of SBRT in 5 fractions. Treatment was then followed by 200 mg of sorafenib taken orally twice a day for 4 weeks. If tolerated, this was escalated to 400 mg twice a day.

Investigators assessed the primary end point of overall survival and secondary end points of progression-free survival, time-to-progression, toxicity, and quality-of-life.

Transcription:

0:08 | Patients with hepatocellular carcinoma have many treatment options. However, the majority of patients present with advanced disease or recur despite intervention such as surgery. Those patients who are not suitable for ablative or curative approaches with surgery transplant, local ablation with the microwave or radiofrequency ablation, and even treatments that are hepatic arterial driven, those patients are generally treated with systemic therapy if they've had progressive disease despite those therapies and are otherwise not candidates.

0:48 | At the time of the study's inception, the standard-of-care was the tyrosine kinase inhibitor sorafenib. For the past few decades, there have been a growing number of reports on the use of external beam radiation therapy for such patients, and many of these patients have invaded the cancer into their major hepatic vessels. Their prognosis is worse regardless of the therapy that is used. They're a tough group of patients to treat. With external beam radiotherapy, there are reports, mostly single centers, a few smaller comparative studies, and a few smaller randomized trials that have suggested benefits with external beam radiation.

1:28 | This trial was designed to evaluate the role of SBRT in these patients, which would predominantly be patients with vascular invasion and tough to treat, locally advanced disease who otherwise would be treated with systemic therapy alone.