This week in Lancet Oncology
, Valérie Vilgrain, M.D., of Hôpitaux de Paris in Clichy, France and colleagues published results from a phase 3 study comparing radiation therapy with yttrium(Y)-90 resin microspheres to standard therapy (sorafenib) in patient with liver cancer.
The study observed that efficacy was the same for both treatments.
Hepatocellular carcinoma is a cancer of the liver with a fairly poor prognosis. The 5-year survival rates range from 3% in advanced stages to approximately 30% in localized forms of the rare cancer. Hepatocellular cancer most frequently develops in people with a history of chronic liver conditons and approximately one-third of patients with liver cirrhosis will develop hepatocellular carcinoma.
Currently, Nexavar (sorafenib) is the recommended treatment for patients with advanced hepatocellular carcinoma. The phase 3 SARAH study was a multicenter, open-label, randomised, phase 3 trial conducted 25 centres in France. Patients with advanced hepatocellular cancer (N=467) were randomized to receive continuous oral sorafenib (400 mg twice daily) or selective internal radiotherapy (SIRT) with 90
Y-loaded resin microspheres 2–5 weeks after randomization. The microspheres are infused into the liver via the hepatic artery where they emit beta radiation.
The primary endpoint was overall survival (OS).
Median OS was 8.0 months (95% CI 6.7–9.9) in the SIRT group versus 9.9 months (8.7–11·4) in the sorafenib group. The difference between the 2 groups was not statistically significant (P
As it pertains to the adverse events (AEs) profile for the 2 treatments, at least 1 serious adverse event was reported in 174 (77%) of 226 patients in the SIRT group and in 176 (82%) of 216 in the sorafenib group. The most common grade 3 or worse treatment-related adverse events were fatigue (9% vs
19%; SIRT vs sorafenib), liver dysfunction (11% vs
13%), increased laboratory liver values (9% vs
7%), haematological abnormalities (10% vs
14%), diarrhoea (1% vs
14%), abdominal pain (3% vs
6%), increased creatinine (2% vs
6%), and hand-foot skin reaction (<1%] vs
A total of 19 deaths in the SIRT group and 12 in the sorafenib group were determined to be related to treatment.
The authors of the study concluded that survival was not different between the 2 treatment options and that “quality of life and tolerance might help when choosing between the two treatments.”
A second study comparing SIRT to soranfenib in patients with advanced helpatocellular cancer was presented earlier this year at the American Socieity of Clinical Oncology (ASCO) meeting in Chicago. That study also found no difference in overall survival rate but did show that significant reduction in adverse events as well as other secondary outcome measures.
In a news release
, lead author of that study, Pierce Chow, M.D., Senior Consultant Surgeon at the National Cancer Centre Singapore said: “We found that the Asian patients with locally advanced HCC who were treated with Y-90 resin microspheres had a significantly better tumour response rate of 16.5% compared to 1.7% for sorafenib (p<0.001) in the intent to treat, or ITT analysis, and 23.1% for SIRT compared to 1.9% (p<0.001) in the treated population, which represents the patients who actually received their allocated treatment. They also experienced almost a two-fold decrease in severe adverse events (grade ≥3; 27.7% vs
. 50.6%; P
< .0001) compared with those treated with sorafenib.”
Vilgrain V, Pereira H, Assenat E, et al. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol.
Published online ahead of print; October 26, 2017. DOI: http://dx.doi.org/10.1016/S1470-2045(17)30683-6
Image courtesy of wikimedia commons.
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