Efficacy and Safety of Metronomic Chemotherapy Versus Palliative Hydroxyurea in Unfit Acute Myeloid Leukemia Patients: A Multicenter, Open-Label Randomized Controlled Trial

Autor: Kanyaporn Charoenprasert, Saranya Pongudom, Yingyong Chinthammitr, Phichayut Phinyo, Klaijith Wongyai, Naiyana Panoi, Harutaya Kasyanan, Jittiporn Purattanamal, Anoree Surawong
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Asian Pacific Journal of Cancer Prevention : APJCP
ISSN: 2476-762X
1513-7368
Popis: Background Management of unfit AML patients is a therapeutic challenge. Most hematologists tend to avoid aggressive treatment leaving patients with a choice of best supportive care. We hypothesized that metronomic chemotherapy could be an alternative treatment for unfit AML patients. Methods A multi-center randomized controlled trial was conducted in seven university-affiliated hospitals in Thailand. Unfit AML patients were recruited and followed up from December 2014 to December 2017. Patients were randomly assigned to receive either metronomic chemotherapy or palliative hydroxyurea. Overall survival rates were compared using Cox's proportional hazard survival analysis. Results A total of 81 eligible patients were randomly allocated and included for ITT analysis. The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097). Conclusion Metronomic chemotherapy could prolong survival time of unfit AML patients, especially in the first 12 months after diagnosis without increasing treatment-associated adverse events.
Databáze: OpenAIRE