Also a trend toward longer survival among those assigned radiation, says Laura Dawson, MD

Single-fraction radiation therapy (RT) reduced hepatic pain among most patients with end-stage hepatocellular carcinoma or liver metastases, according to results of a phase III study presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposiumopens in a new tab or window.

In this exclusive MedPage Today video, Laura A. Dawson, MD, of Princess Margaret Cancer Centre in Toronto, discusses the results of the studyopens in a new tab or window.

Following is a transcript of her remarks:

I had the opportunity to present the results of a randomized phase III study led through the Canadian Clinical Trials Group HE.1. It was a 1:1 randomization to palliative radiotherapy in one fraction versus best supportive care for patients who suffer from pain or discomfort from their primary or metastatic liver cancer.

And the primary objective was to determine the proportion of patients who benefit from the therapy compared to best supportive care. Patients had to have cancers that were unsuitable for standard local or regional or systemic therapies. And their minimal pain score had to be 4 on a scale from 0 to 10, and stable, and bothersome despite attempts at analgesia and steroid and other standard supportive care.

So in this study, there were patients with many different primary cancers who had a very large burden of disease in their liver. No patient was going to be offered any future study — no immunotherapy, targeted therapies. or chemotherapy. And the primary endpoint was in fact 1 month after the simple intervention.

Radiotherapy was given with an antiemetic as though there was a very large volume of the abdomen that was radiated, as many patients had very advanced disease.

So the primary endpoints were met in the study. There was clinically important and statistically significant improvement in pain. So 67% of patients who received the single dose of radiotherapy reported an improvement of pain by 2 or more on their pain scale when asked, “What is your pain at worst in the past 24 hours with radiation?” Whereas with best supportive care alone, only 22% of patients reported an improvement.

The other pain questions were also improved with the use of radiotherapy. And we did a sensitivity analysis where we assumed everyone who did not complete their pain questionnaires at 1 month had worse pain. And with the sensitivity analysis, there remains statistically significant and clinically important improvement in pain.

There was a trend to improved quality of life, and the adverse events were similar. There was some transient grade 2 GI toxicity and fatigue that was reversible. And so overall this intervention was well tolerated.

We also had a secondary endpoint of survival at 3 months. And with radiotherapy, 51% of patients lived at 3 months versus 33% with best supportive care. The P value is 0.07. So it’s hypothesis-generating, but very intriguing, and hopefully will open the door for more palliative radiotherapy studies in the setting of patients who suffer from hepatic pain, whether it be from primary liver cancer or from liver metastases.