Multicenter randomized phase 3 study of palliative radiotherapy versus best supportive care in patients with painful hepatic cancer

Palliative treatment options for painful hepatic cancer can be restricted due to patients eventually becoming refractory to standard treatment. The phase 3 CCTG HE1 study, at nine centers in Canada, evaluated radiotherapy (RT) plus best supportive care (BSC) for painful liver metastasis or hepatocellular carcinoma. Patients were randomized 1:1 to single-fraction RT plus BSC (n=33) or BSC alone (n=33). Improvement of worst pain with at least 2 points on the 10-points Brief Pain Inventory at one month was seen in 67% of evaluable patients in the RT plus BSC group versus 22% in the BSC-alone group (p=0.0042). The most common grade 3 or 4 adverse events within one month were abdominal pain (9% in the RT plus BSC group versus 3% in the BSC-alone group) and ascites (6% versus 3%). No serious adverse events or treatment-related deaths were observed. The authors conclude that addition of single-fraction RT to BSC improved pain compared with BSC alone in patients with painful liver cancer.