scholarly journals Efficacy, tolerability and impact on quality of life of selective internal radiation therapy (with yttrium-90 resin microspheres) or sorafenib in patients with locally advanced hepatocellular carcinoma: The SARAH trial

2017 ◽  
Vol 28 ◽  
pp. iii150 ◽  
Author(s):  
Mohamed Bouattour ◽  
Eric Assenat ◽  
Boris Guiu ◽  
Diana Ilonca Alina ◽  
Georges-Philippe Pageaux ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hepatocellular Carcinoma ◽  
Radiation Therapy ◽  
Locally Advanced ◽  
Advanced Hepatocellular Carcinoma ◽  
Selective Internal Radiation Therapy ◽  
Internal Radiation ◽  
Resin Microspheres ◽  
Yttrium 90

Nemesis: Non-inferiority meta-analysis of selective internal radiation therapy with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma: A preliminary analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15604-e15604
Author(s):  
Marino Venerito ◽  
Maciej Pech ◽  
Ali Canbay ◽  
Rossella Donghia ◽  
Vito Guerra ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiation Therapy ◽  
Meta Analysis ◽  
Advanced Hepatocellular Carcinoma ◽  
Selective Internal Radiation Therapy ◽  
Internal Radiation ◽  
Advanced Hcc ◽  
Selective Internal Radiation ◽  
Resin Microspheres ◽  
Yttrium 90

e15604 Background: No survival benefit has been observed for selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres versus (vs.) sorafenib in patients with advanced hepatocellular carcinoma (HCC). In NEMESIS, we assessed by an individual patient data meta-analysis whether SIRT, either as monotherapy or followed by sorafenib, is non-inferior to sorafenib and compared safety profiles. Here we present preliminary data. Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Library, up to 6 December 2018, found three randomized trials comparing SIRT as monotherapy, or followed by sorafenib, to sorafenib monotherapy among patients with advanced HCC. The main outcomes were overall survival (OS) and frequency of adverse events (AEs). Survival data were pooled (fixed effect analysis). The primary population for non-inferiority analysis was the per-protocol (PP) population. The non-inferiority margin for the hazard ratio (HR) upper boundary was set at 1.08 as specified in EASL guidelines. Results: The three included trials compared sorafenib to SIRT (SIRveNIB and SARAH) or to SIRT followed by sorafenib (SORAMIC) in 1243 patients. After randomization, 23.3% vs. 7.1% of patients (p < 0.0001) did not receive the allocated intervention, and 542/608 (89.1%) vs. 418/635 (65.8%), (odds ratio [OR] 4.3, 95% CI: 3.2-5.8, p < 0.0001) completed the study without major protocol deviations (PP population), in the SIRT and sorafenib arms, respectively. Baseline characteristics of the PP population did not differ between the two comparison groups. Median OS with SIRT followed or not by sorafenib was non-inferior to sorafenib (HR 0.90, 95% CI 0.78–1.02). Treatment-related AEs grades ≥3 were reported in 109/356 (30.6%) patients who received SIRT and 197/378 (52.1%) patients in the sorafenib arm (SIRveNIB and SARAH only, p = 0.0002). Conclusions: SIRT as initial therapy for advanced HCC is non-inferior to sorafenib in OS, and offers a better safety profile.

Phase III multi-centre open-label randomized controlled trial of selective internal radiation therapy (SIRT) versus sorafenib in locally advanced hepatocellular carcinoma: The SIRveNIB study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4002-4002 ◽  
Author(s):  
Pierce H. W. Chow ◽  
Mihir Gandhi ◽  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiation Therapy ◽  
Hepatic Metastasis ◽  
Locally Advanced ◽  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Selective Internal Radiation Therapy ◽  
Internal Radiation ◽  
Selective Internal Radiation ◽  
Internal Radiation Therapy

4002 Background: The optimal therapeutic regime for locally advanced hepatocellular carcinoma (HCC) with and without vascular invasion remains unclear. This study evaluates the efficacy of Selective Internal Radiation Therapy using SIR-Spheres yttrium-90 microspheres (Y90) versus sorafenib in Asian Barcelona Clinic Liver Cancer (BCLC) stage B and C patients without extra-hepatic metastasis. Methods: This investigator-initiated multi-center trial randomized eligible patients with locally advanced inoperable HCC to single injection of Y90 or sorafenib (oral 400mg BD) till progressive disease or unacceptable toxicity. The sample size, assuming type I error (two-sided) of 0.05 and power of 90% was 360 patients. Final analysis was planned at 266 reported deaths. Results: 360 patients (182 Y90, 178 sorafenib) were enrolled from 27 centers in 11 Asian countries. BCLC C patients without extra-hepatic metastasis comprised 41.4% of patients, 30.6% had portal vein thrombosis (PVT), 88.6% were Child-Pugh A, 57.2% were hepatitis B and 15.0% were hepatitis C. Altogether 28.6% and 9.0% of patients in the Y90 and sorafenib arms respectively failed to receive planned therapy. Intention-to-treat analysis was carried out with the overall survival (OS) in the Y90 and sorafenib arms being 8.54 and 10.58 months respectively (Hazard ratio (HR) 1.17, p =0.203). Tumour response rate (TRR) was 16.5% and 1.7% (p < 0.001) respectively. Time-to-tumor -progression (TTP) was 5.88 vs 5.36 (overall) (HR 0.93) and 6.08 vs 5.39 (liver-specific) (HR 0.91) months for Y90 and sorafenib respectively. Progression-free-survival (PFS) was 5.29 vs 5.06 (overall) (HR 0.94) and 5.85 vs 5.06 (liver-specific) (HR 0.92) months respectively. At least one severe adverse event was found in 27.7% and 50.6% of patients in the Y90 and sorafenib arms respectively. Conclusions: Asian patients with locally advanced HCC without extra-hepatic metastasis treated with Y90 have statistically significant better TRR, and fewer SAEs when compared with those treated with sorafenib. There were no statistically significant differences in OS between Y90 and sorafenib. Clinical trial information: NCT01135056.

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