2 METHODS
A single-center, cross-sectional, observational study was conducted over 15 months (January 2016 to March 2017). Patients treated for hematological malignancy in the Pediatric Hematology-Oncology Unit, Postgraduate Institute of Medical Education and Research, Chandigarh, India, were screened. Children who were >6 months from completion of therapy and had received ≥5 red cell units during treatment or within 3 months before diagnosis were enrolled. Patients with relapsed disease, second-malignancy, or those who had received a hematopoietic stem cell transplant (HSCT) were excluded. Protocol adapted from UKALL 2003 trial was followed for risk stratification and treatment of patients with acute lymphoblastic leukemia (ALL).8 Chemotherapy adopted from the AML15 trial was used to treat acute myeloid leukemia (AML).9
Serum ferritin and T2*MRI were performed for estimation of iron overload. The myocardial iron concentration (MIC) and LIC were measured by T2*MRI. C-reactive protein (CRP) was done as a surrogate marker of inflammation. A serum ferritin value was considered for assessment of iron status when the corresponding CRP level was within range. If CRP was elevated (>10 mg/L), serum ferritin and CRP were repeated 4 weeks later.
Iron overload was defined as serum ferritin exceeding 1000 ng/ml. LIC was graded as normal (<2 mg/g), mild (2-7 mg/g), moderate (7-15 mg/g) or severe (>15 mg/g) iron overload.6 MIC was graded as normal (<1.16 mg/g), mild (1.16-1.65 mg/g), moderate (1.65-2.71 mg/g) or severe (>2.71 mg/g) iron overload.7Echocardiography was performed in children with cardiac iron overload (MIC >1.16 mg/g).
The study was approved by the ethics committee of the institution (INT/IEC/2016/1138). Informed consent was obtained from the participants/guardians.