https://scholars.lib.ntu.edu.tw/handle/123456789/540454
標題: | Phase 2 study of tabalumab, a human anti-B-cell activating factor antibody, with bortezomib and dexamethasone in patients with previously treated multiple myeloma | 作者: | Raje N.S. Moreau P. Terpos E. Benboubker L. Grząśko N. Holstein S.A. Oriol A. SHANG-YI HUANG Beksac M. Kuliczkowski K. Tai D.F. Wooldridge J.E. Conti I. Kaiser C.J. Nguyen T.S. Cronier D.M. Palumbo A. |
關鍵字: | B-cell activating factor (BAFF); bortezomib; multiple myeloma; tabalumab; treatment | 公開日期: | 2017 | 出版社: | Blackwell Publishing Ltd | 卷: | 176 | 期: | 5 | 起(迄)頁: | 783-795 | 來源出版物: | British Journal of Haematology | 摘要: | In this double-blind, Phase 2 study, 220 patients with relapsed/refractory multiple myeloma were randomly assigned 1:1:1 to receive placebo (N = 72), tabalumab 100 mg (N = 74), or tabalumab 300 mg (N = 74), each in combination with dexamethasone 20 mg and subcutaneous bortezomib 1·3 mg/m2 on a 21-day cycle. No significant intergroup differences were observed among primary (median progression-free survival [mPFS]) or secondary efficacy outcomes. The mPFS was 6·6, 7·5 and 7·6 months for the tabalumab 100, 300 mg and placebo groups, respectively (tabalumab 100 mg vs. placebo Hazard ratio (HR) [95% confidence interval (CI)] = 1·13 [0·80-1·59], P = 0·480; tabalumab 300 mg vs. placebo HR [95% CI] = 1·03 [0·72-1·45], P = 0·884). The most commonly-reported treatment-emergent adverse events were thrombocytopenia (37%), fatigue (37%), diarrhoea (35%) and constipation (32%). Across treatments, patients with low baseline BAFF (also termed TNFSF13B) expression (n = 162) had significantly longer mPFS than those with high BAFF expression (n = 55), using the 75th percentile cut-off point (mPFS [95% CI] = 8·3 [7·0-9·3] months vs. 5·8 [3·7-6·6] months; HR [95% CI] = 1·59 [1·11-2·29], P = 0·015). Although generally well tolerated, PFS was not improved during treatment with tabalumab compared to placebo. A higher dose of 300 mg tabalumab did not improve efficacy compared to the 100 mg dose. Nonetheless, BAFF appears to have some prognostic value in patients with multiple myeloma. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85007137226&doi=10.1111%2fbjh.14483&partnerID=40&md5=94fc97826acf9a3b83f00dd0b45cf87a https://scholars.lib.ntu.edu.tw/handle/123456789/540454 |
ISSN: | 0007-1048 | DOI: | 10.1111/bjh.14483 | SDG/關鍵字: | bortezomib; dexamethasone; placebo; tabalumab; antineoplastic agent; bortezomib; dexamethasone; monoclonal antibody; tabalumab; adult; aged; anemia; area under the curve; Article; cancer combination chemotherapy; constipation; controlled study; coughing; diarrhea; dizziness; double blind procedure; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; febrile neutropenia; female; human; insomnia; kidney failure; major clinical study; male; maximum plasma concentration; multicenter study; multiple cycle treatment; multiple myeloma; nausea; overall survival; peripheral edema; peripheral neuropathy; phase 2 clinical trial; pneumonia; progression free survival; randomized controlled trial; sensory neuropathy; sepsis; septic shock; thrombocytopenia; time to maximum plasma concentration; upper respiratory tract infection; clinical trial; complication; disease free survival; middle aged; mortality; multiple myeloma; procedures; salvage therapy; treatment outcome; Adult; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Disease-Free Survival; Double-Blind Method; Female; Humans; Male; Middle Aged; Multiple Myeloma; Salvage Therapy; Treatment Outcome |
顯示於: | 醫學系 |
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