Dexamethasone versus Prednisone in Childhood Acute Lymphoblastic Leukemia Treatment: Results of the Indonesian Randomized Trial — Oak Academic Publishing
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Dexamethasone versus Prednisone in Childhood Acute Lymphoblastic Leukemia Treatment: Results of the Indonesian Randomized Trial
Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
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Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
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Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
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Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands
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Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
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Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
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Pediatric Oncology/Hematology Division, Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands
1 Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
2 Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
3 Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
4 Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands
5 Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
6 Pediatric Hematology and Oncology Division, Department of Pediatrics, Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia
7 Pediatric Oncology/Hematology Division, Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands
Background : Randomized trials report that, compared to prednisone, dexamethasone has reduced CNS relapse and improved event-free survival (EFS), despite a trend toward a higher risk for induction death. Because toxic death is a specific problem in the Indonesian setting, this study compares the outcome of dexamethasone versus prednisone. Methods : In the period 2006 - 2011, 196 patients with childhood acute lymphoblastic leukemia (ALL) treated on the Indonesia-ALL-2006 protocol [first standard risk (SR) and later high risk (HR) patients] were randomized to receive dexamethasone or prednisone as steroid. Patients in the dexamethasone arm (n = 102: 68 SR, 34 HR) received dexamethasone 4 mg/m2/day (SR) or 6 mg/m 2 /day (HR), while the prednisone arm (n = 94: 66 SR, 28 HR) received prednisone 40 mg/m2/day (SR and HR). Results : Patients in the dexamethasone arm showed no significant difference compared to the prednisone arm in abandonment rate (24.5% vs. 25.5%, P = 0.91), death rate (17.7% vs. 14.9%, P = 0.54), or leukemic events (13.7 vs. 11.7%, P = 0.59). After stratification for risk group, a trend towards a higher death rate was found in the dexamethasone arm of SR patients (16.2 vs. 6.1%, P = 0.06). The 3-year survival for EFS in SR and HR patients for dexamethasone versus prednisone was 31.5% ± 6.6% vs. 41.5% ± 5.9% ( P = 0.51), for leukemia-free survival (LFS) it was 63.7% ± 9.3% vs. 74.5% ± 7.6% ( P = 0.47), and for overall survival (OS) it was 49.5% ± 7.7% vs. 69.3% ± 6.1% ( P = 0.09). Conclusions : In our setting, a trend toward higher induction deaths was observed in the dexamethasone arm of SR patients and the 3-year EFS; LFS and OS rates were lower in the dexamethasone group; however, these differences were not significant.
KeywordsDexamethasone versus PrednisoneChildhood ALLIndonesia
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