Mahachoklertwattana 2004.
Methods | Study type: prospective single‐centre study Setting: Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand | |
Participants | 24 children (median age at diagnosis 3.5 years (range 1 to 14 years); 13 boys and 11 girls) with newly diagnosed ALL | |
Interventions | According to modification of St. Jude Children's Research Hospital Total XIII Protocol for ALL: standard induction therapy: prednisolone, vincristine, L‐asparaginase, doxorubicin, etoposide, and cytosine arabinoside
Type of glucocorticoid therapy: induction phase: oral prednisolone (40 mg/m2/d, divided into 3 daily doses) for 28 consecutive days. At 4 weeks after completion of induction therapy, children received maintenance therapy consisting of a 7‐day course of high‐dose dexamethasone 8 mg/m2/d, every 4 weeks, in conjunction with other chemotherapeutic agents according to risk classification.
Cumulative prednisolone dose was 1120 mg/m2. Cumulative dexamethasone dose per child depended upon how long the child was followed up. Dexamethasone course (56 mg/m2/d) was administered at 4, 8, 12, and 16 weeks after induction therapy. Maximum cumulative dose of dexamethasone (4 courses) was 224 mg/m2.
Duration of glucocorticoid therapy: 28 days of prednisolone and an additional 7‐day course of dexamethasone
Methods of cessation of glucocorticoid therapy: abrupt No control intervention |
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Outcomes | Specific HPA axis function test: serum cortisol level at 8 a.m., at diagnosis (baseline); low‐dose ACTH stimulation test (1 µg cosyntropin (Cortrosyn, Organon, West Orange, NJ)) at 8 a.m. after an overnight fast (basal cortisol and after 30 minutes) Moment of testing: Baseline adrenal function was assessed by determination of serum cortisol level at 8 a.m. before induction therapy. The first low‐dose ACTH stimulation test was performed 2 weeks after discontinuation of prednisolone. Children with adrenal insufficiency underwent repeated ACTH testing 4 weeks after completion of the prednisolone course and every 4 weeks thereafter in the morning of the day on which children were admitted for the next course of maintenance chemotherapy until normalisation. Tests were performed during treatment for ALL. Cutoff limits defined by original studies: basal cortisol: not defined. Low‐dose ACTH test: normal response ≥ 18 µg/dL (≥ 500 nmol/L) |
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Notes | 0 children were lost to follow‐up. Length of follow‐up after glucocorticoid therapy: up to 20 weeks Funding source: not mentioned Declaration of interest among primary researchers: not mentioned |