Trial reportClinical lymphoma, myeloma & leukemia2013
Decitabine can be safely reduced after achievement of best objective response in patients with myelodysplastic syndrome.
Trial report in Clinical lymphoma, myeloma & leukemia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundDecitabine is standard therapy in patients with myelodysplastic syndrome (MDS). Current recommendations suggest a dose of 20 mg/m(2) intravenously (IV) daily for 5 days every 4 weeks. However, this therapy is associated with frequent grade 3/4 hematologic toxicity, requiring dose delays and/or dose reductions (DD/DR).
resultsWe investigated the outcomes of 122 patients with MDS who had DD/DR of frontline decitabine therapy. Sixty-five patients (53%) had DR by at least 25% or DD (defined as a delay beyond 5 weeks between cycles). Thirty-five patients (29%) underwent DD/DR after achieving best objective response, 30 patients (25%) underwent DD/DR before best objective response, and 57 (54%) patients had no DD/DR. There was a trend for more durable responses in favor of patients requiring DD/DR after the achievement of best objective response (median not reached) (P = .161). Overall survival rates were significantly higher for patients who had DD/DR after best objective response compared with those who had DD/DR before best objective response or those with no DD/DR (30 vs. 22 vs. 11 months, respectively; P < .001). Progression-free survival (PFS) rates also trended higher for those with DD/DR after best objective response (median not reached) compared with those who required DD/DR before best objective response (median of 15 months) (P = .285).
conclusionDD/DR may be safely accomplished once the patient has achieved best objective response (preferably complete remission [CR]) without impacting outcome. Prospective evaluation of an approach conceived of a loading dose for induction of a best objective response followed by a maintenance schedule is to be considered.
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