期刊
BLOOD
卷 116, 期 26, 页码 5838-5841出版社
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2010-08-303487
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资金
- National Cancer Institute, Department of Health and Human Services [CA32102, CA38926, CA04919, CA35431, CA14028, CA67575, CA35090, CA58861, CA20319, CA35178, CA76429, CA35176, CA68183, CA95860, CA27057, CA35119, CA35281, CA45808, CA37981, CA16385, CA76448, CA63848, CA12644, CA86780, CA46282, CA58658, CA11083, CA58882, CA58416]
- Celgene Corporation
- Celgene
- Millennium
The Southwest Oncology Group conducted a randomized trial comparing lenalidomide (LEN) plus dexamethasone (DEX; n = 97) to placebo (PLC) plus DEX (n = 95) in newly diagnosed myeloma. Three 35-day induction cycles applied DEX 40 mg/day on days 1 to 4, 9 to 12, and 17 to 20 together with LEN 25 mg/day for 28 days or PLC. Monthly maintenance used DEX 40 mg/day on days 1 to 4 and 15 to 18 along with LEN 25 mg/day for 21 days or PLC. Crossover from PLC-DEX to LEN-DEX was encouraged on progression. One-year progression-free survival, overall response rate, and very good partial response rate were superior with LEN-DEX (78% vs 52%, P = .002; 78% vs 48%, P < .001; 63% vs 16%, P < .001), whereas 1-year overall survival was similar (94% vs 88%; P = .25). Toxicities were more pronounced with LEN-DEX (neutropenia grade 3 or 4: 21% vs 5%, P < .001; thromboembolic events despite aspirin prophylaxis: 23.5% [initial LEN-DEX or crossover] vs 5%; P < .001). This trial was registered at www.clinicaltrials.gov as #NCT00064038. (Blood. 2010;116(26):5838-5841)
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