Originally published as JCO Early Release 10.1200/JCO.2008.20.3869 on August 31 2009

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High-Dose Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: High Rates of Rapid Cytogenetic and Molecular Responses

From The University of Texas M. D. Anderson Cancer Center, Houston; Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio, San Antonio; Southwest Regional Cancer Center, Austin, TX; John Theurer Cancer Center at Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Wake Forest University Comprehensive Cancer Center, Winston-Salem, NC; Roswell Park Cancer Institute, Buffalo, NY; Indiana Blood and Marrow Transplantation, Beech Grove, IN; Rocky Mountain Cancer Center, Colorado Springs, CO; Georgia Cancer Specialists, Atlanta, GA; Quest Diagnostics, Northridge, CA; and the Fred Hutchinson Cancer Research Center, Seattle, WA.

Corresponding author: Jorge Cortes, MD, Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 428, Houston, TX 77030; e-mail: jcortes{at}mdanderson.org.

Purpose Long-term clinical outcome data have established imatinib 400 mg/d as standard front-line treatment for newly diagnosed patients with chronic myeloid leukemia (CML).

Patients and Methods The Rationale and Insight for Gleevec High-Dose Therapy (RIGHT) trial is a multicenter study of imatinib 400 mg twice a day as initial therapy in 115 patients (70% Sokal low risk) with newly diagnosed CML in chronic phase who were observed for both molecular and cytogenetic responses for up to 18 months. Eighty-three patients (72%) completed the study, 10 patients (9%) discontinued the study because of adverse events, and six patients (5%) discontinued because of unsatisfactory therapeutic effect.

Results Polymerase chain reaction analysis demonstrated rapid kinetics of major molecular response (MMR), with 48% of patients achieving MMR by 6 months, 54% by 12 months, and 63% by 18 months. Corresponding complete molecular response rates were 39%, 44%, and 55%, respectively. Median dose-intensity was 98%. Overall, 79% of patients who received at least 90% dose-intensity achieved MMR. The most frequent adverse events included myelosuppression, rash, fatigue, and musculoskeletal symptoms.

Conclusion This study suggests that imatinib 400 mg twice a day results in more rapid reduction in tumor burden than imatinib 400 mg/d with minimal added toxicity.

Written on the behalf of the Rationale and Insight for Gleevec High-Dose Therapy (RIGHT) Trial Study Group.

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

Clinical Trials repository link available on JCO.org.

Clinical trial information can be found for the following: NCT00081926 [ClinicalTrials.gov] .

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