Abstract | PURPOSE: METHODS: RESULTS: Eighty-four patients with myelofibrosis-associated anemia were randomly assigned to the aforementioned treatment arms: 22, 19, 22, and 21, respectively. Response in anemia was documented in 20 patients, including 15 who became transfusion independent. Response rates in the four treatment arms were 23% (95% CI, 5% to 41%), 16% (95% CI, 0% to 33%), 36% (95% CI, 16% to 56%), and 19% (95% CI, 2% to 36%). The corresponding figures for patients receiving > or = 3 cycles of treatment (n = 62) were 38%, 23%, 40%, and 25%. Response to pomalidomide with or without prednisone was durable (range, 3.2 to 16.9+ months) and significantly better in the absence of leukocytosis (37% v 8%; P = .01); JAK2V617F or cytogenetic status did not affect response. Grade > or = 3 toxicities were infrequent and included (in each treatment arm) neutropenia (9%; 16%; 5%; 5%), thrombocytopenia (14%; 16%; 9%; 5%), and thrombosis (9%; 5%; 0%; 0%). CONCLUSION:
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Authors | Ayalew Tefferi, Srdan Verstovsek, Giovanni Barosi, Francesco Passamonti, Gail J Roboz, Heinz Gisslinger, Ronald L Paquette, Francisco Cervantes, Candido E Rivera, H Joachim Deeg, Juergen Thiele, Hans M Kvasnicka, James W Vardiman, Yanming Zhang, B Nebiyou Bekele, Ruben A Mesa, Robert P Gale, Hagop M Kantarjian |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 27
Issue 27
Pg. 4563-9
(Sep 20 2009)
ISSN: 1527-7755 [Electronic] United States |
PMID | 19652059
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Glucocorticoids
- Hematinics
- Immunologic Factors
- Thalidomide
- pomalidomide
- Prednisone
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Anemia
(drug therapy, etiology)
- Double-Blind Method
- Female
- Glucocorticoids
(administration & dosage)
- Hematinics
(administration & dosage)
- Humans
- Immunologic Factors
(administration & dosage)
- Male
- Middle Aged
- Prednisone
(administration & dosage)
- Primary Myelofibrosis
(complications)
- Prospective Studies
- Thalidomide
(administration & dosage, analogs & derivatives)
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