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Stereotactic body radiation therapy combined with Nexavar showed a clinically important improvement in overall survival in locally advanced hepatocellular carcinoma.
Stereotactic body radiation therapy (SBRT) administered prior to Nexavar (sorafenib) was associated with a clinically important but not statistically significant improvement in overall survival (OS) compared with Nexavar alone in patients with locally advanced hepatocellular carcinoma (HCC), according to study findings published in JAMA Oncology.
CURE® spoke with lead study author Dr. Laura Dawson, a professor and chair of the department of Radiation Oncology at the University of Toronto, and a practicing radiation oncologist at Radiation Medicine Program at Princess Margaret Cancer Center, University Health Network in Toronto, to discuss more about SBRT and the treatment’s future implications for patients with HCC.
“[SBRT] allows the radiation to be delivered in fewer fractions than with conventional radiation, so typically two to five treatments, as opposed to conventional historical radiation, that often was delivered over 20 or sometimes 30 treatments over more than a month,” said Dawson.
Overall survival (OS): the length of time a patient lives after diagnosis.
Progression-free survival (PFS): the length of time a patient lives without the disease getting worse.
Macrovascular invasion: the spread of cancer into large blood vessels.
In this NRG/RTOG1112 trial, after a median follow-up of 13.2 months for all patients and 33.7 months for surviving patients, the median OS was 12.3 months with Nexavar alone versus 15.8 months following treatment with SRBT and Nexavar. After adjusting for stratification factors, the OS continued to show improvement with SBRT and Nexavar. In addition, the median progression-free survival (PFS) rate was improved from 5.5 months with Nexavar alone to 9.2 months with the combination.
Furthermore, improved quality-of-life was seen in two out of 20 patients in the Nexavar alone group and six out of 17 patients in the combo group, at six months.
Of note, 74% of patients had macrovascular invasion, which, as described by Dawson, is a particularly tough presentation of liver cancer.
“I hope that anyone who does have a presentation of cancer with invasion into the vein or macrovascular invasion can be considered for radiotherapy. Not everyone is a candidate, but having this as another treatment in the armatorium for patients is very important,” said Dawson.
Regarding safety, grade 3 (severe) treatment-related adverse events (TRAEs, side effects) were experienced by 37 out of 88 patients treated with Nexavar alone, and 39 out of 83 patients treated with SBRT and Nexavar. Although TRAEs were recorded, Dawson discussed the difficulty to determine the direct cause of such side effects.
“The majority of the symptoms are due to the advanced cancer, and so if there is some reduction of the cancer form treatment, there may be reduction of 'adverse events' and even improved quality of life, with no worsening of symptoms, despite additional treatments,” said Dawson.
There were two treatment-related deaths in the Nexavar group (causes unspecified and liver failure) and one in the SBRT and Nexavar group (lung infection).
In the Nexavar alone group, patients were to receive 400 milligrams (mg) orally twice daily. For patients assigned to the combination group, 200 mg of Nexavar would be taking orally twice daily starting days 1 – 5, and, if tolerable, escalation of Nexavar to 400 mg, orally twice daily after one month.
The primary end goal of this trial was OS, with secondary end goals including PFS, safety and quality-of-life.
“The question is, now that the standard of care for many patients is immunotherapy based, how does radiation fit for patients who are getting immunotherapy? There is uncertainty. I would hypothesize that radiation is going to help these patients, as it did for patients in the NRG/RTOG1112 trial, but we don't know that for sure,” said Dawson.
She further mentions that participation in trials of immunotherapy and radiation therapy will help us to learn about benefits, risks and best sequencing of theses therapies.
Reference:
“Stereotactic Body Radiotherapy vs Sorafenib Alone in Hepatocellular Carcinoma The NRG Oncology/RTOG1112 Phase 3 Randomized Clinical Trial.” By Dr. Laura Dawson, et al. Jama Oncology.
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