Radiation therapy

The phase III NRG/RTOG 1112 study (NCT01730937) evaluated sorafenib alone or SBRT followed by sorafenib in patients with HCC. Patients were included if they had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, new or recurrent HCC. Patients also had five or fewer lesions, a tumor sum measuring 20 cm or less, and distant metastases measuring 3 cm or less. A total of 177 patients were randomly assigned (92 to sorafenib alone, 85 to SBRT followed by sorafenib). The primary end point was OS.[16][Level of evidence B1]

The phase III NRG/RTOG 1112 study (NCT01730937) evaluated sorafenib alone or SBRT followed by sorafenib in patients with HCC. Patients were included if they had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, new or recurrent HCC. Patients also had five or fewer lesions, a tumor sum measuring 20 cm or less, and distant metastases measuring 3 cm or less. A total of 177 patients were randomly assigned (92 to sorafenib alone, 85 to SBRT followed by sorafenib). The primary end point was OS.[16][Level of evidence B1]

The median OS was 12.3 months for the sorafenib-alone group and 15.8 months for the SBRT-plus-sorafenib group (hazard ratio [HR], 0.77; one-sided P = .0554). This was not statistically significant.

The phase III NRG/RTOG 1112 study (NCT01730937) evaluated sorafenib alone or SBRT followed by sorafenib in patients with HCC. Patients were included if they had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, new or recurrent HCC. Patients also had five or fewer lesions, a tumor sum measuring 20 cm or less, and distant metastases measuring 3 cm or less. A total of 177 patients were randomly assigned (92 to sorafenib alone, 85 to SBRT followed by sorafenib). The primary end point was OS.[16][Level of evidence B1]

Grade 3 or higher adverse events were not significantly different between the two groups: 42% for the sorafenib-alone group and 47% for the SBRT-plus-sorafenib group (P = .52).

The phase III NRG/RTOG 1112 study (NCT01730937) evaluated sorafenib alone or SBRT followed by sorafenib in patients with HCC. Patients were included if they had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, new or recurrent HCC. Patients also had five or fewer lesions, a tumor sum measuring 20 cm or less, and distant metastases measuring 3 cm or less. A total of 177 patients were randomly assigned (92 to sorafenib alone, 85 to SBRT followed by sorafenib). The primary end point was OS.[16][Level of evidence B1]

There were three grade 5 adverse events: one hepatic failure and one death not otherwise specified in the sorafenib-alone group and one grade 5 lung infection in the SBRT-plus-sorafenib group.

The Canadian Cancer Trials Group HE.1 trial (NCT02511522), a phase III study published in abstract form, included 66 patients with HCC. Patients were randomly assigned to receive either best supportive care alone or palliative radiation therapy to the liver (8 Gy in one fraction). Patients had end-stage disease unsuitable for local, regional, or systemic therapies. Patients also had to be more than 4 weeks from receiving chemotherapy or transcatheter arterial chemoembolization, more than 2 weeks from receiving targeted therapy or immunotherapy, and not planning any systemic therapy. The primary outcome of the study was the proportion of patients who reported an improvement of at least two points from baseline on the Brief Pain Inventory when asked to rate their liver cancer pain "intensity at worst." A secondary end point included 3-month OS.[17][Level of evidence B3]

The Canadian Cancer Trials Group HE.1 trial (NCT02511522), a phase III study published in abstract form, included 66 patients with HCC. Patients were randomly assigned to receive either best supportive care alone or palliative radiation therapy to the liver (8 Gy in one fraction). Patients had end-stage disease unsuitable for local, regional, or systemic therapies. Patients also had to be more than 4 weeks from receiving chemotherapy or transcatheter arterial chemoembolization, more than 2 weeks from receiving targeted therapy or immunotherapy, and not planning any systemic therapy. The primary outcome of the study was the proportion of patients who reported an improvement of at least two points from baseline on the Brief Pain Inventory when asked to rate their liver cancer pain "intensity at worst." A secondary end point included 3-month OS.[17][Level of evidence B3]

A significant improvement in the “worst” pain score from baseline to 1 month was seen in 67% of patients who received radiation therapy and 22% of patients who received best supportive care.

The Canadian Cancer Trials Group HE.1 trial (NCT02511522), a phase III study published in abstract form, included 66 patients with HCC. Patients were randomly assigned to receive either best supportive care alone or palliative radiation therapy to the liver (8 Gy in one fraction). Patients had end-stage disease unsuitable for local, regional, or systemic therapies. Patients also had to be more than 4 weeks from receiving chemotherapy or transcatheter arterial chemoembolization, more than 2 weeks from receiving targeted therapy or immunotherapy, and not planning any systemic therapy. The primary outcome of the study was the proportion of patients who reported an improvement of at least two points from baseline on the Brief Pain Inventory when asked to rate their liver cancer pain "intensity at worst." A secondary end point included 3-month OS.[17][Level of evidence B3]

Although radiation therapy has not been historically used in this patient population, this study showed no decrease in OS for patients who received radiation. The 3-month OS rate was 51% for patients who received radiation therapy and 33% for patients who received best supportive care alone (P = .07), despite the study including patients with Child-Pugh class A, B, and C cirrhosis.