Abstract

HERNANDEZ PADRON, Carlos et al. Newly diagnosed acute promyelocytic leukemia. Treatment with arsenic trioxide produced in cuba. (Arsenin®). Rev Cubana Hematol Inmunol Hemoter [online]. 2014, vol.30, n.4, pp.346-359. ISSN 0864-0289.

Introduction: Arsenic trioxide has demonstrated its effectiveness in the treatment of promyelocytic leukemia, so much in patients newly diagnosed as in those in relapse. Methods:  From 2008 to 2011, 51 patients, children and adults, newly diagnosed with promyelocytic leukemia were treated with arsenic trioxide as first line therapy. Objectives:   1. Evaluation of the effectiveness of arsenic trioxide manufactured in Cuba (Arsenin ®) in the treatment of this disease as first-line drug. 2. Study of the clinical-hematological behavior of patients. 3. Identification of major adverse reactions and complications. 4. Determine the median time to hematological remission. 5. Comparison of our results with those of the LPM-2003 protocol.  Results: The main adverse reactions were:  hepatotoxicity and cardiotoxicity, only 3 patients discontinued the medication and finally passed the previous scheme, LPM- 2003. There were 5 early deaths. The 43 patients who complied with the treatment achieved hematological remission to 42,8 days on average. There were no significant differences in time to achieve hematological remission, overall survival and event-free between this protocol and the LPM -03 protocol. All patients have at least 2 years of stopping treatment and there has been no regrettable relapse. After two years of stopping treatment overall survival of the 51 patients is 90,1 %.  Conclusions:  We consider that Arsenin ® is effective as first-line drug in the treatment of newly diagnosed disease.

Keywords : promyelocytic leukemia; arsenic trioxide; all trans retinoic acid.

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