https://scholars.lib.ntu.edu.tw/handle/123456789/511355
標題: | SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma | 作者: | Chow P.K.H. Gandhi M. Tan S.-B. Khin M.W. Khasbazar A. Ong J. Choo S.P. Cheow P.C. Chotipanich C. Lim K. Lesmana L.A. Manuaba T.W. Yoong B.K. Raj A. Law C.S. Cua I.H.Y. Lobo R.R. Teh C.S.C. Kim Y.H. Jong Y.W. Han H.-S. Bae S.-H. Yoon H.-K. Lee R.-C. Hung C.-F. Peng C.-Y. PO-CHIN LIANG Bartlett A. Kok K.Y.Y. Thng C.-H. Low A.S.-C. Goh A.S.W. Tay K.H. Lo R.H.G. Goh B.K.P. Ng D.C.E. Lekurwale G. Liew W.M. Gebski V. Mak K.S.W. Soo K.C. |
公開日期: | 2018 | 卷: | 36 | 期: | 19 | 起(迄)頁: | 1913-1921 | 來源出版物: | Journal of Clinical Oncology | 摘要: | 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. ? 2018 by American Society of Clinical Oncology. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/511355 | ISSN: | 0732-183X | DOI: | 10.1200/JCO.2017.76.0892 | SDG/關鍵字: | sorafenib; yttrium 90; antineoplastic agent; microsphere; sorafenib; yttrium; abdominal pain; adult; advanced cancer; alopecia; anemia; Article; ascites; Asia; cancer growth; clinical effectiveness; comparative study; constipation; controlled study; coughing; decreased appetite; diarrhea; edema; fatigue; female; fever; hand foot syndrome; hepatitis; human; hypertension; hypoalbuminemia; jaundice; liver cell carcinoma; liver cirrhosis; major clinical study; male; middle aged; multicenter study; nausea; open study; overall survival; Pacific islands; peripheral edema; phase 3 clinical trial; portal hypertension; portal vein thrombosis; priority journal; progression free survival; quality of life; radioembolization; randomized controlled trial; rash; survival rate; treatment outcome; treatment response; upper gastrointestinal bleeding; brachytherapy; clinical trial; Kaplan Meier method; liver cell carcinoma; liver tumor; procedures; prospective study; Antineoplastic Agents; Brachytherapy; Carcinoma, Hepatocellular; Female; Humans; Kaplan-Meier Estimate; Liver Neoplasms; Male; Microspheres; Middle Aged; Prospective Studies; Sorafenib; Yttrium Radioisotopes |
顯示於: | 醫學院附設醫院 (臺大醫院) |
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