Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Chow Pierce K H, Gandhi Mihir, Tan Say-Beng, Khin Maung Win, Khasbazar Ariunaa, Ong Janus, Choo Su Pin, Cheow Peng Chung, Chotipanich Chanisa, Lim Kieron, Lesmana Laurentius A, Manuaba Tjakra W, Yoong Boon Koon, Raj Aloysius, Law Chiong Soon, Cua Ian H Y, Lobo Rolley R, Teh Catherine S C, Kim Yun Hwan, Jong Yun Won, Han Ho-Seong, Bae Si-Hyun, Yoon Hyun-Ki, Lee Rheun-Chuan, Hung Chien-Fu, Peng Cheng-Yuan, Liang Po-Chin, Bartlett Adam, Kok Kenneth Y Y, Thng Choon-Hua, Low Albert Su-Chong, Goh Anthony S W, Tay Kiang Hiong, Lo Richard H G, Goh Brian K P, Ng David C E, Lekurwale Ganesh, Liew Wei Ming, Gebski Val, Mak Kenneth S W, Soo Khee Chee, Asia-Pacific Hepatocellular Carcinoma Trials Group
Аннотация
Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.