Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232)
| Autor: | Jeffrey A. Zonder, Dennis F. Moore, Bart Barlogie, Vanessa Bolejack, Brian G.M. Durie, Muneer H. Abidi, Brock F. Whittenberger, Mohamad A. Hussein, John Crowley |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Randomization Adolescent medicine.drug_class Clinical Trials and Observations Immunology Neutropenia Placebo Biochemistry Dexamethasone law.invention Young Adult Randomized controlled trial law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine polycyclic compounds Humans Lenalidomide Multiple myeloma Aged Cross-Over Studies business.industry Remission Induction Cell Biology Hematology Middle Aged medicine.disease Thalidomide Survival Rate Treatment Outcome Corticosteroid Female business Multiple Myeloma hormones hormone substitutes and hormone antagonists medicine.drug |
| Zdroj: | Blood. 116(26) |
| ISSN: | 1528-0020 |
| Popis: | 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][1] as #[NCT00064038][2]. [1]: http://www.clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00064038&atom=%2Fbloodjournal%2F116%2F26%2F5838.atom |
| Databáze: | OpenAIRE |
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