Mojtaba Ghadiany1, Mahdi Tabarraee1, Sina Salari1, Shirin Haghighi1, Hamid Rezvani1, Seyedeh Najmeh Ghasemi2, Hamidreza Karimi-Sari3. 1. Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2. Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: dr.nghasemi@yahoo.com. 3. Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Abstract
BACKGROUND: The hypothesis of an effect by thiazolidinedione on leukemia cells was proposed 2 decades ago, but there is little clinical evidence regarding its efficacy. We evaluated the safety and efficacy of adding pioglitazone to standard induction chemotherapy in patients with acute myeloid leukemia (AML). PATIENTS AND METHODS: In this randomized clinical trial, newly diagnosed AML patients were randomized to 1 of 2 groups. Patients in both groups received cytarabine (100 mg/m2 per day for 7 days) and daunorubicin (60 mg/m2 per day for 3 days). Patients in the pioglitazone group additionally received oral pioglitazone (45 mg per day). The 2 groups were compared according to remission rate, laboratory findings, and adverse events during treatment. RESULTS:Forty patients were evaluated, 20 patients in each group. The complete remission rate was 20% more in the pioglitazone group compared to the control group (P = .202). Complications due to pioglitazone discontinuation were observed in 2 cases. The mean serum alanine aminotransferase in the fourth treatment week was significantly more in pioglitazone group compared to the control group (65.5 vs. 33.6 mg/dL, P = .039). The mean serum creatinine in all treatment phases was significantly higher in the pioglitazone group compared to the control group (P < .05). There were no significant differences between the 2 groups regarding other laboratory findings (P > .05). CONCLUSION: Adding pioglitazone to cytarabine and daunorubicin increased the remission rate in AML patients compared to control subjects. Although this difference in remission rate between the 2 groups was not statistically significant, it could be important in the clinical setting. Pioglitazone may provide benefits as an adjuvant therapy for AML patients without causing serious adverse events.
RCT Entities:
BACKGROUND: The hypothesis of an effect by thiazolidinedione on leukemia cells was proposed 2 decades ago, but there is little clinical evidence regarding its efficacy. We evaluated the safety and efficacy of adding pioglitazone to standard induction chemotherapy in patients with acute myeloid leukemia (AML). PATIENTS AND METHODS: In this randomized clinical trial, newly diagnosed AMLpatients were randomized to 1 of 2 groups. Patients in both groups received cytarabine (100 mg/m2 per day for 7 days) and daunorubicin (60 mg/m2 per day for 3 days). Patients in the pioglitazone group additionally received oral pioglitazone (45 mg per day). The 2 groups were compared according to remission rate, laboratory findings, and adverse events during treatment. RESULTS: Forty patients were evaluated, 20 patients in each group. The complete remission rate was 20% more in the pioglitazone group compared to the control group (P = .202). Complications due to pioglitazone discontinuation were observed in 2 cases. The mean serum alanine aminotransferase in the fourth treatment week was significantly more in pioglitazone group compared to the control group (65.5 vs. 33.6 mg/dL, P = .039). The mean serum creatinine in all treatment phases was significantly higher in the pioglitazone group compared to the control group (P < .05). There were no significant differences between the 2 groups regarding other laboratory findings (P > .05). CONCLUSION: Adding pioglitazone to cytarabine and daunorubicin increased the remission rate in AMLpatients compared to control subjects. Although this difference in remission rate between the 2 groups was not statistically significant, it could be important in the clinical setting. Pioglitazone may provide benefits as an adjuvant therapy for AMLpatients without causing serious adverse events.
Authors: Ludmila Gouveia-Eufrasio; Noelly Queiroz Ribeiro; Julliana Ribeiro Alves Santos; Marliete Carvalho da Costa; Elúzia Castro Peres Emídio; Gustavo José Cota de Freitas; Paulo Henrique Fonseca do Carmo; Bárbara Alves Miranda; João Carlos Maia Dornelas de Oliveira; Lívia Mara Vitorino da Silva; Victor Augusto Teixeira Leocádio; Vanessa Caroline Randi Magalhães; Indiara Penido; Leonardo Soares Pereira; Lívia Frota Rabelo; Flávio Augusto de Almeida Faria; Maria Rita Teixeira Dutra; Maíra Aspahan; Ludmila de Paula; Dirce Inês da Silva; Márcia Gregory Tavares Melo; Virginia Antunes de Andrade Zambelli; André Augusto Gomes Faraco; Isabela da Costa César; Glauciene Prado Alves; Lívia Fulgêncio da Cunha Melo; Nalu Teixeira de Aguiar Peres; Daniel Assis Santos Journal: Contemp Clin Trials Commun Date: 2021-02-10