Patients with hepatocellular carcinoma whose tumors couldn’t be surgically removed lived longer and experienced few side effects after stereotactic body radiotherapy, according to phase 2 study findings.
Stereotactic body radiotherapy can help patients with hepatocellular carcinoma whose tumors can’t be surgically removed live longer, according to study findings published in Cancer. Not only did the therapy extend overall survival, but it was also safe for patients.
The treatment uses special equipment to directly deliver radiation to the tumor and is divided into several smaller doses that are given to a patient over several days.
In a phase 2 clinical trial that involved six institutions in South Korea, researchers studied the safety and efficacy of stereotactic body radiotherapy. The trial included 74 patients who were a median age of 61 years and enrolled between January 2012 and April 2015 — only 65 eligible patients were analyzed. The patients had either primary or recurrent hepatocellular carcinoma, which is the most common type of primary liver cancer, and tumors were less than 10 centimeters. Hepatitis B virus (HBV) infection was the predominant cause of liver disease in 64% of the patient population.
“Because HBV infection is endemic in Korea and almost 90% of patients with (hepatocellular carcinoma) have underlying cirrhosis or chronic HBV infection, both tumor control and the prevention of hepatic decompensation are essential requirements for the treatment
of (the disease),” the researchers wrote.
Stereotactic body radiotherapy was delivered to patients using three fractions within 14 days, with at least 48-hour intervals between fractions. Regular follow-up visits were scheduled for two, four, six, nine and 12 months, and every four to six months thereafter until disease progression or death. The visits included history taking, physical examination, complete blood cell counts, chemistry panels and CT scan or MRI.
Patients who experienced side effects between visits were encouraged to come in for an evaluation at any time. To evaluate side effects relating to the stomach and duodenum (the first part of the small intestine), the researchers performed an esophagogastroduodenoscopy, a procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum, before and two months after stereotactic body radiotherapy.
With a median follow up of 41 months, the researchers saw low treatment-related severe side effects and a high rate of tumor control. One month after therapy, one patient experienced radiation-induced liver disease. At five months, another patient had a grade 3 esophageal ulcer with stenosis, or the narrowing of the spaces within a person’s spine. At one year, the rate of treatment-related side effects was 3%.
In addition, the researchers examined progression-free survival (PFS), or the length of time during and after treatment that patients lived with the disease without their disease worsening, and overall survival (OS). At two years, PFS was 48% and OS was 84%. Those rates were lower at three years, 36% and 76%, respectively.
“This prospective study demonstrated that stereotactic body radiotherapy for hepatocellular carcinoma was well tolerated and was an effective treatment modality after long-term median follow-up of 41 months,” the researchers wrote. “Our study encourages a randomized comparison of stereotactic body radiotherapy versus other treatment modalities for hepatocellular carcinoma.”