SIRT does not improve survival vs sorafenib in locally advanced HCC
Selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres does not improve overall survival (OS) vs sorafenib in patients with locally advanced hepatocellular carcinoma (HCC), although it significantly improves tumour response and reduces adverse events (AEs), the phase III SARAH study has shown.
In the intention-to-treat population, median OS was 8 months in the SIRT group (n=237) vs 9.9 months in the sorafenib group (n=222) (p=0.18), according to results reported at the European Society for Medical Oncology (ESMO) 19th World Congress on Gastrointestinal Cancer (WCGC 2017) held in Barcelona, Spain. [WCGC 2017, abstract LBA-001]
Similarly, no difference in OS was found in the per protocol population between the SIRT group (n=174) and sorafenib group (n=206) (median, 9.9 vs 9.9 months).
“OS results were consistent when patients were stratified by age, gender, disease severity, tumour characteristics, and laboratory investigation results,” reported investigator Dr Mohamed Bouattour of Hôpital Beaujon in Paris, France.
“Progression-free survival also did not differ significantly between SIRT and sorafenib in both the intention-to-treat and per protocol populations. However, radiologic progression with liver as the first site was significantly reduced with SIRT vs sorafenib, although no significant differences were seen for progression outside the liver,” he continued.
Despite a lack of survival benefit, SIRT was associated with a significantly higher objective response rate than sorafenib (19 vs 15.2 percent; p=0.042).
Similar to previous findings, SIRT was associated with significantly fewer AEs of any grade and grade ≥3 AEs compared with sorafenib (p<0.001 for both). Fewer patients in the SIRT arm had ≥1 AEs of any grade or grade ≥3 AEs (p<0.001 for both).
“SIRT was associated with significantly lower rates of grade ≥3 fatigue, weight loss, hand and foot skin reactions, diarrhoea, abdominal pain and hypertension compared with sorafenib,” Bouattour reported. “Quality of life was significantly better in the SIRT group, as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30], although only 65 questionnaires were completed.”
The SARAH study included 467 patients (mean age, 65 years; 90 percent male) with locally advanced or inoperable HCC who had failed treatment with transarterial chemoembolization (TACE). The median sorafenib dose was 800 mg, the median cumulative period of intake was 2.8 months, and treatment discontinuation rate was 61.1 percent.
Findings of SARAH are similar to those of the phase II SIRveNIB trial, which were presented recently at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting.
In SIRveNIB, no significant difference in OS was shown between SIRT and sorafenib in 360 patients with locally advanced HCC. However, SIRT was associated with significantly higher tumour response rates and significantly fewer AEs. [ASCO 2017, abstract 4002]
“Results of the two studies suggest that sorafenib remains the standard of care,” said discussant Dr Michel Ducreux of Institut Gustave Roussy in Villejuif, France.