Abstract | PURPOSE: PATIENTS AND METHODS: We analyzed 362 low-risk, transfusion-dependent patients with MDS, with or without the del(5q) abnormality, enrolled in two phase II studies (MDS-003 and MDS-002) to determine whether treatment-related cytopenias are correlated with lenalidomide response. Cytopenias were assessed during the first 8 weeks of therapy, and response was defined as TI; response predictors were explored in univariate and multivariate analyses. RESULTS: Among patients with del(5q), 70% of those whose platelet count decreased by > or = 50% achieved TI, as compared with 42% of those whose platelet count remained stable or declined by less than 50% (P = .01). Among patients without baseline neutropenia, 82% of those whose absolute neutrophil count (ANC) decreased by > or = 75% achieved TI, as compared with 51% whose ANC remained stable or decreased by less than 75% (P = .02). These relationships were consistent in multivariate analyses. No relationship between the development of cytopenias and response could be established for lower-risk patients with MDS without del(5q). CONCLUSION: These findings support the hypothesis that a direct cytotoxic effect of lenalidomide specific to the del(5q) clone may be indicative of a TI response.
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Authors | Mikkael A Sekeres, Jaroslaw P Maciejewski, Aristotle A N Giagounidis, Kenton Wride, Robert Knight, Azra Raza, Alan F List |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 26
Issue 36
Pg. 5943-9
(Dec 20 2008)
ISSN: 1527-7755 [Electronic] United States |
PMID | 19018091
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Thalidomide
- Lenalidomide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Erythrocyte Transfusion
- Female
- Humans
- Lenalidomide
- Male
- Middle Aged
- Myelodysplastic Syndromes
(drug therapy, genetics, therapy)
- Neutropenia
(chemically induced)
- Thalidomide
(analogs & derivatives, therapeutic use)
- Thrombocytopenia
(chemically induced)
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