As reported in The Lancet Oncology by Laura A. Dawson, MD, of the University Health Network–Princess Margaret Cancer Centre, University of Toronto, and colleagues, the Canadian phase III CCRG HE1 trial showed that the addition of a single fraction of palliative radiotherapy to best supportive care reduced pain in patients with painful hepatic cancer.

Study Details

In the open-label multicenter trial, 66 patients were randomly assigned between July 2015 and June 2022 to receive radiotherapy plus best supportive care (n = 33) or best supportive care alone (n = 33). Treatment consisted of single-fraction radiotherapy at 8 Gy to the liver with 8 mg of ondansetron (or its equivalent) and 4 mg of dexamethasone given 1 to 2 hours before radiotherapy and best supportive care including nonopioid or opioid analgesia, dexamethasone, or their combination.

Patients had pain or discomfort at its worst in the past 24 hours of ≥ 4 of 10 points on the Brief Pain Inventory (BPI) that was stable after optimization of analgesia for up to 7 days before randomization. The primary outcome measure was improvement in patient-reported liver cancer pain or discomfort of ≥ 2 points on worst pain intensity on the BPI at 1 month after randomization.

Pain Response

At data cutoff (September 2022), median follow-up was 3.2 months (95% confidence interval [CI] = 3.0–3.4 months). Totals of 24 patients (73%) in the radiotherapy/best supportive care group and 18 patients (55%) in the best supportive care–alone group had baseline and 1-month pain assessments.

Improvement in hepatic pain of ≥ 2 points in worst pain intensity on the BPI at 1 month was observed in 16 of 24 patients (67%) in the radiotherapy/best supportive care group vs 4 of 18 patients (22%) in the best supportive care–alone group (P = .0042). Compared with baseline, at 1 month, patients in the radiotherapy/best supportive care group had a median reduction in opioid use of 6.25 morphine mg equivalents per day, whereas patients in the best supportive care–alone group had a median increase of 34.00 morphine mg equivalents per day.

Adverse Events

In the total population, grade ≥ 2 adverse events within 1 month after randomization occurred in 58% of the radiotherapy/best supportive care group vs 33% of the best supportive care–alone group (P = .08). Grade 3 or 4 adverse events within 1 month after randomization were reported in 18% vs 12%; the most common events in the radiotherapy/best supportive care group were abdominal pain (9% vs 3% in best supportive care–alone group) and ascites (6% vs 3%). No serious adverse events or treatment-related deaths were reported.

The investigators concluded: “Single-fraction radiotherapy plus best supportive care improved pain compared with best supportive care alone in patients with liver cancer and could be considered a standard palliative treatment.”

DISCLOSURE: The study was funded by the Canadian Cancer Society. For full disclosures of the study authors, visit thelancet.com.