ENGLISH ABSTRACT
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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[Effect of metformin addition to an acute lymphoblastic leukemia chemotherapy treatment].

BACKGROUND: Recently it has been reported a benefit effect with the use of metformin in patients with malignant disease. Our objective was to evaluate the effect of adding metformin to chemotherapy regimen over the percentage of early relapse in acute lymphoblastic leukemia.

METHODS: A prospective, longitudinal and experimental study was performed in patients with de novo acute lymphoblastic leukemia enrolled in the Hospital General de México. They were divided in two groups: first group received chemotherapy + metformin (850 mg three times a day); second group only received standard chemotherapy. The sample was randomized 3:1 in favor of the second group.

RESULTS: 93 patients were included (73 treated with chemotherapy + metformin and 20 received standard chemotherapy), with 303 ± 53 days of follow-up. Complete remission was higher in the group without metformin (81.3 % [n = 61] versus 70 % [n = 14]), which also presented more patients with relapse (47.9 % versus 25 %). Overall survival at one year was of 68 % and free survival disease was 64 %, without significant differences between groups. Absence of metformin was the only variable of adverse prognostic considered significant (p = 0.55). Cox regression showed that adding metfomin reduced 56 % the risk of relapse.

CONCLUSIONS: The adding metformin to the treatment of leukemias showed that was useful in our research. However, randomized and double-blind studies must be designed in order to express final recommendations about its use.

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