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Second-line CML drugs evoke faster response than front-line therapy
Date:12/7/2009

Administration for patients who can't tolerate imatinib or whose CML resists the drug.

The dasatinib trial has enrolled 62 patients with previously untreated early stage CML taking either 50 mg twice daily or 100 mg once a day. Among 50 patients followed for at least three months, 49 (98 percent) achieved complete cytogenetic response. Major molecular response, a more stringent measure of remission, was reached in 35 patients (70 percent) with five (10 percent) achieving complete molecular response.

The researchers have dropped the twice daily arm of the trial, keeping the 100 mg once a day arm open because it has produced higher rates of major molecular response with fewer side effects.

The nilotinib trial has enrolled 65 patients with the 400mg twice daily dose producing complete cytogenetic responses in 50 of 51 patients (98 percent) followed for at least three months. Major molecular response has been achieved in 32 patients (63 percent) with 12 (24 percent) achieving complete molecular response.

All patients in both trials are alive, and enrollment continues. Side effects are being closely monitored and some patients in each trial had their treatment reduced or temporarily interrupted because of toxicities. Side effects are manageable and similar to those seen for imatinib, Cortes said.

Early results for both comparisons

Months on therapy Percent of patients with Complete Cytogenetic Response
Dasatinib Imatinib 400mg Imatinib 800mg
3 82 37 63
6 94 54 85
12 98 65 89
18 89 67 89
24 84 67 88
30 83 67 89

Months on therapy Percent of patients with Complete Cytogenetic Response (Number of valuable patients)
Nilotinib Imatinib 400mg Imatinib 800mg
3 90 37 63
6 96 54 85
12 97 65 89
18 93 67 89
24 93 67 88
30 92 67 89


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Contact: Scott Merville
smerville@mdanderson.org
713-516-4855
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert

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