Underlying data for ‘Association of leukocyte nadir with complete remission in Indonesian acute myeloid leukemia patients undergoing 7+3 remission induction chemotherapy’
Description
This is a dataset of prognostic study with a retrospective cohort design. The sample was taken by total sampling from the medical record data of patients with a diagnosis of AML who were not acute promyelocytic leukemia (APL) or AML M3 FAB classification who underwent 7+3 induction chemotherapy at Dharmais Hospital National Cancer Center and Dr. Cipto Mangunkusumo National Central Public Hospital during the period from January 1st, 2015 to December 31st, 2019. The study was approved by the Universitas Indonesia Ethics Board, approval number KET-603/UN2.F1/ETIK/PPM.00.02/2021. Data was collected from June 15th to August 31st 2021. The acceptance criteria of this study were patients aged ≥18 years, diagnosed of AML based on at least bone marrow smear or biopsy and bone marrow aspirate or peripheral blood immunophenotyping, underwent first-line remission induction chemotherapy 7+3 regimen, and had never undergone any remission induction chemotherapy before. The criteria for rejection were AML M3 (FAB criteria) or acute promyelocytic leukemia (APL), a myeloblastic crisis phase of chronic myeloid leukemia (CML) or when the required data was not found in the patient's medical record. The nadir leukocyte level and the time required to reach it were assessed for their associations to the occurrence of CR during the evaluation of 7+3 remission induction chemotherapy treatment. Treatment evaluations were done when the peripheral blood cells had recovered. The criteria used to define the occurrence of CR during treatment evaluation were in accordance with those established by European LeukemiaNet 2017. Factors considered as potential confounders were age, gender, AML subtype, Charlson Comorbidity Index (CCI), history of myelodysplasia syndrome (MDS), history of chemotherapy/radiotherapy, prechemotherapy leukocyte level, bone marrow myeloblast cell level at diagnosis, occurrence of febrile neutropenia and administration of granulocyte colony stimulating factor (GCSF).
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Data processing was carried out using IBM SPSS Statistics version 28. Numerical data were presented in mean with a standard deviation if the distribution was normal or as a median with a range if the distribution was not normal. Statistical significance testing was carried out according to the characteristics of the data and their objectives. Bivariate testing on nominal data was carried out by using the chi-square test or by using Fisher's exact test as an alternative if the requirements were not met. To see the difference in the mean in two groups with numerical data that had a normal distribution, an unpaired t-test was used, or the alternative Mann-Whitney U test was used instead if the distribution was not normal. The limit of significance (α) was set at 5% in the conclusion of statistical significance. For data on nadir leukocyte levels and the time required to achieve it in the form of numerical data, the most optimal threshold was sought through the ROC (receiver operating characteristic) curve by assessing sensitivity and specificity values. The power of discrimination of the two variables was measured by the AUC (area under the curve) value. The strength of the association was expressed in terms of relative risk (RR) or odds ratio (OR) with a 95% confidence interval (CI). Variables that had the potential to become confounders were assessed for their relationship with CR occurrence through the bivariate test. When there was a variable that had p-value <0.25 in the bivariate test, this variable would be further analyzed through multivariate logistic regression test to determine whether the variables acted as a confounder or not by looking at the changes in the OR it caused. A variable was defined as a confounder when it changed the OR (ΔOR) >10%.