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Continued azacitidine therapy beyond time of first response improves quality of response in patients with higher‐risk myelodysplastic syndromes
Author(s) -
Silverman Lewis R.,
Fenaux Pierre,
Mufti Ghulam J.,
Santini Valeria,
HellströmLindberg Eva,
Gattermann Norbert,
Sanz Guillermo,
List Alan F.,
Gore Steven D.,
Seymour John F.
Publication year - 2011
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.25774
Subject(s) - azacitidine , medicine , complete response , myeloid leukemia , confidence interval , oncology , hypomethylating agent , myelodysplastic syndromes , clinical trial , international prognostic scoring system , bone marrow , chemotherapy , biochemistry , gene expression , chemistry , dna methylation , gene
BACKGROUND: In the AZA‐001 trial, azacitidine (75 mg/m 2 /d subcutaneously for Days 1‐7 of every 28‐day cycle) demonstrated improved survival compared with conventional care regimens in patients with International Prognostic Scoring System‐defined intermediate‐2‐ or high‐risk myelodysplastic syndrome and World Health Organization‐defined acute myeloid leukemia with 20% to 30% bone marrow blasts. METHODS: This secondary analysis of the AZA‐001 phase 3 study evaluated the time to first response and the potential benefit of continued azacitidine treatment beyond first response in responders. RESULTS: Overall, 91 of 179 patients achieved a response to azacitidine; responding patients received a median of 14 treatment cycles (range, 2‐30). Median time to first response was 2 cycles (range, 1‐16). Although 91% of first responses occurred by 6 cycles, continued azacitidine improved response category in 48% of patients. Best response was achieved by 92% of responders by 12 cycles. Median time from first response to best response was 3.5 cycles (95% confidence interval [CI], 3.0‐6.0) in 30 patients who ultimately achieved a complete response, and 3.0 cycles (95% CI, 1.0‐3.0) in 21 patients who achieved a partial response. CONCLUSIONS: Continued azacitidine therapy in responders was associated with a quantitative increase in response to a higher response category in 48% of patients, and therefore may enhance clinical benefit in patients with higher‐risk MDS. Cancer 2011. © 2011 American Cancer Society.