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AML patients have high response rate with vorinostat added to treatment
Date:12/12/2011

ion, and another seven had complete remission with incomplete platelets (CRp), for an overall response rate of 85 percent. Median overall survival was 82 weeks and median event free survival was 47 weeks.

Overall response rate for 11 patients with the high-risk Flt-3 ITD mutation was 100 percent, with 10 achieving complete remissions and the other a CRp. Their median overall survival was 91 weeks and median event free survival was 66 weeks.

Of 29 patients who were diploid (a pair of each chromosome, double the usual number), 25 had complete remissions and two achieved CRp, for an overall response rate of 93 percent. Their median overall survivial was 105 weeks and event-free survival was 68 weeks.

Seventeen patients with -5/-7 cytogenetic alterations fared less well, with a 64 percent overall response rate and median overall survival of 34 weeks and median event free survival of 14 weeks.

Side effects

No cardiac toxicities and no excess toxicity related to vorinostat were observed. Common side effects were diarrhea (72 percent), nausea and vomiting (65 percent) and skin toxicities (38 percent).

Nineteen patients who achieved either CR or CRp had blood stem cell transplants. Median overall survival and event free survival had not been reached for those patients.

Garcia-Manero said levels of two proteins, NRF2 and CYBB, were associated with longer survival.

Phase III clinical trial

There will be three arms for the randomized, blinded Phase III clinical trial:

  • Standard frontline therapy of seven days of cytarabine infusion and three days of the anthracycline antibiotic daunirubicin.
  • MD Anderson standard frontline therapy of three days of idarubicin with high-dose continuous infusion of cytarabine for four days.
  • Three days of idarubicin, four days of cytarabine plus vorinostat.


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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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