Laura A. Dawson, MD, FRCPC, discusses quality-of-life outcomes from the NRG/RTOG 1112 study of stereotactic body radiation therapy followed by sorafenib versus sorafenib alone in hepatocellular carcinoma.
Laura A. Dawson, MD, FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, discusses quality-of-life (QOL) outcomes from the NRG/RTOG 1112 study (NCT01730937) of stereotactic body radiation therapy (SBRT) followed by sorafenib (Nexavar) vs sorafenib alone in patients with hepatocellular carcinoma.
QOL outcomes were reported at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The FACT-Hep Functional Assessment of Cancer Therapy – Hepatobiliary tool was used to assess patients on this trial, with a hypothesis that patients receiving SBRT would have better QOL at 6 months compared with those receiving sorafenib alone. Dawson says that only 37 out of 177 patients completed the questionnaire for baseline and at 6 months, and due to the low statistical power of the results, they were reported without statistical analysis.
The results showed that 35% of patients who received SBRT had a QOL improvement of 5 or more points, vs only 10% who received sorafenib only, meeting the main QOL end point. Dawson says this aligns with the higher rate of stable disease vs disease progression in patients who received SBRT. The addition of SBRT also showed improvement in other end points such as overall survival and time to progression, as well as no increase in serious adverse events (AEs).
0:08 | The newest outcome that was reported at ASCO GI was QOL. The QOL FACT-Hep tool was used for patients who consented to complete their QOL at baseline at 6 months and 12 months. Of the 177 patients who were treated in the protocol, there were 83 who consented to the QOL. However, only 37 patients completed the baseline QOL and 6-month QOL, and the primary hypothesis in the QOL portion of the study was that those patients with SBRT would be more likely to have improved QOL at 6 months.
0:54 | Given the low power to look at statistical testing, the statistics experts on the study recommended that we report results without any statistics. We did report them and looking at the primary end point…there was a higher proportion of patients who received SBRT who had improved QOL. Thirty-five percent of patients had an improvement by 5 or more points—that's a clinically significant interval—compared with 10% of patients who were given sorafenib alone.
1:38 | Similarly, there were more patients who had stable disease and less patients who had a decline when looking at those patients who received SBRT compared with sorafenib. It is aligned with what we saw with improved responses, lower time-to-progression, improved survival, and similar or even lower serious AEs, probably due to tumor. Although the power is low, the trend is strongly favoring the SBRT as well.