Originally published as JCO Early Release 10.1200/JCO.2008.19.6550 on June 15 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Steensma, D. P. Articles by Kantarjian, H. PubMed PubMed Citation Articles by Steensma, D. P. Articles by Kantarjian, H. Social Bookmarking                            What's this?

Multicenter Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Myelodysplastic Syndromes: The Alternative Dosing for Outpatient Treatment (ADOPT) Trial

From the Mayo Clinic Rochester, MN; Roswell Park Cancer Institute, Buffalo, NY; Mayo Clinic, Phoenix, AZ; Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada; University of Chicago, Chicago, IL; The University of Texas M. D. Anderson Cancer Center, Houston, TX; Quest Diagnostics Nichols Institute, San Juan Capistrano, CA; and MGI Pharma, Bloomington, MN.

Corresponding author: David P. Steensma, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: steensma.david{at}mayo.edu.

Purpose Decitabine, a DNA-targeted hypomethylating agent, is approved by the United States Food and Drug Administration for treatment of patients with myelodysplastic syndromes (MDS) on a schedule of 15 mg/m² administered via intravenous (IV) infusion every 8 hours for 3 days. This study assessed the efficacy and safety of an alternative dosing regimen administered on an outpatient basis in academic and community-based practices.

Patients and Methods Patients were treated with decitabine 20 mg/m² by IV infusion daily for 5 consecutive days every 4 weeks. Eligible patients were 18 years of age and had MDS (de novo or secondary) of any French-American-British (FAB) subtype and an International Prognostic Scoring System (IPSS) score 0.5. The primary end point was the overall response rate (ORR) by International Working Group (IWG 2006) criteria; secondary end points included cytogenetic responses, hematologic improvement (HI), response duration, survival, and safety.

Results Ninety-nine patients were enrolled; the ORR was 32% (17 complete responses [CR] plus 15 marrow CRs [mCRs]), and the overall improvement rate was 51%, which included 18% HI. Similar response rates were observed in all FAB subtypes and IPSS risk categories. Among patients who improved, 82% demonstrated responses by the end of cycle 2. Among 33 patients assessable for a cytogenetic response, 17 (52%) experienced cytogenetic CR (n = 11) or partial response (n = 6).

Conclusion Decitabine given on a 5-day schedule provided meaningful clinical benefit for patients with MDS, with more than half demonstrating improvement. This suggests that decitabine can be administered in an outpatient setting with comparable efficacy and safety to the United States Food and Drug Administration–approved inpatient regimen.

Supported by MGI Pharma (now Eisai Corporation of North America).

Presented in abstract form at the American Society of Hematology 2007 Annual Meeting, December 8-10, 2007, Atlanta, GA; 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL; and the 13th Congress of the European Hematology Association, June 12-15, 2008, Copenhagen, Denmark.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00260065 [ClinicalTrials.gov] .

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?