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Blood, 15 November 2008, Vol. 112, No. 10, pp. 3965-3973.
Prepublished online as a Blood First Edition Paper on September 3, 2008; DOI 10.1182/blood-2008-06-161737.
 Previous Article | Next Article 
Submitted June 6, 2008
Accepted August 19, 2008
Impact of early dose intensity on cytogenetic and molecular responses in chronic phase CML patients receiving 600 mg/day of imatinib as initial therapy
Timothy P Hughes*, Susan Branford, Deborah L White, John Reynolds, Rachel Koelmeyer, John F Seymour, Kerry Taylor, Chris Arthur, Anthony Schwarer, James Morton, Julian Cooney, Michael F Leahy, Philip Rowlings, John Catalano, Mark Hertzberg, Robin Filshie, Anthony K Mills, Keith Fay, Simon Durrant, Henry Januszewicz, David Joske, Craig Underhill, Scott Dunkley, Kevin Lynch, and Andrew Grigg
Institute of Medical and Veterinary Science, Adelaide, SA, Australia
Australasian Leukaemia and Lymphoma Group, ALLG, Melbourne, VIC, Australia
Novartis Pharmaceuticals Australia, Novartis, Sydney, NSW, Australia
* Corresponding author; email: timothy.hughes{at}imvs.sa.gov.au.
We conducted a trial in 103 patients with newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) using imatinib 600mg/day, with dose escalation to 800mg/day for suboptimal response. The estimated cumulative incidences of complete cytogenetic response (CCR) by 12 and 24 months were 88% and 90%, and major molecular response (MMR) were 47% and 73%. In patients who maintained a daily average of 600mg of imatinib for the first 6 months (n=60), MMR rates by 12 and 24 months were 55% and 77% compared to 32% and 53% in patients averaging <600mg (p=0.037; 0.016). Dose escalation was indicated for 17 patients before 12 months for failure to achieve, or maintain, major cytogenetic response at 6 months or CCR at 9 months, but was only possible in 8 patients (47%). Dose escalation was indicated for 73 patients after 12 months because their BCR-ABL level remained >0.01% (international scale), and was possible in 45/73 (62%). Patients able to dose escalate and those remaining on 600mg achieved superior responses to patients receiving <600mg. Superior responses achieved in patients able to tolerate imatinib at 600mg suggests that early dose intensity may be critical to optimise response in CP-CML. The trial was registered at www.ANZCTR.org.au as ACTRN12607000614493.
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