Phase III Datsatinib Trial

[Guest guest]

Hi Everyone,

I found this article in the LLS news letter. Thought you might find it

interesting.

Don

Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J,

Müller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman

MS.

M. D. Cancer Center, Houston, TX 77030-1402, USA.

hkantarj@...

Dasatinib is the most potent BCR-ABL inhibitor, with 325-fold higher potency

than imatinib against unmutated BCR-ABL in vitro. Studies have demonstrated the

benefits of dasatinib 70 mg twice daily in patients with accelerated-phase

chronic myeloid leukemia intolerant or resistant to imatinib. A phase 3 study

compared the efficacy and safety of dasatinib 140 mg once daily with the current

twice-daily regimen. Here, results from the subgroup with accelerated-phase

chronic myeloid leukemia (n = 317) with a median follow-up of 15 months

(treatment duration, 0.03-31.15 months) are reported. Among patients randomized

to once-daily (n = 158) or twice-daily (n = 159) treatment, rates of major

hematologic and cytogenetic responses were comparable (major hematologic

response, 66% vs 68%; major cytogenetic response, 39% vs 43%, respectively).

Estimated progression-free survival rates at 24 months were 51% and 55%, whereas

overall survival rates were 63% versus 72%. Once-daily treatment was associated

with an improved safety profile. In particular, significantly fewer patients in

the once-daily group experienced a pleural effusion (all grades, 20% vs 39% P <

..001). These results demonstrate that dasatinib 140 mg once daily has similar

efficacy to dasatinib 70 mg twice daily but with an improved safety profile.

This trial is registered at www.clinicaltrials.gov as #CA180-035.