Sutaryo Sutaryo, Widjajanto Pudjo Hagung, Mulatsih Sri, Ardianto Bambang, Pangarso Alexandra Widita Swipratami, Supriyadi Eddy, Purwanto Ignatius, Adelin Claudia Priska, Lestari Rahmadani Puji, Sagoro Lintang, Christian Scholastika Dita, Sabrina Dea Sella, Verena Natasha, Kors Wijnanda Adriana, Kaspers Gertjan J L, Veerman Anjo J P
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia.
Department of Hemato-Oncology, Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Pediatr Blood Cancer. 2022 Nov;69(11):e29875. doi: 10.1002/pbc.29875. Epub 2022 Jul 20.
The prognosis of childhood acute lymphoblastic leukemia (ALL) in Indonesia, a lower-middle-income country (LMIC), is lower than in high income countries (HICs). The Indonesian ALL2013 protocol resulted in too many toxic deaths (21%) and abandonments (11%). Therefore, we drafted an adapted protocol, ALL2016. Main changes: no anthracyclines in standard risk (SR), prednisone replaced dexamethasone at induction in high risk (HR), and anthracyclines and cyclophosphamide were rescheduled in HR.
Patients (aged: 1-18 years) were stratified into SR and HR. HR was defined as age over 10 years, leucocyte count over 50 × 10 /L, central nervous system (CNS) involvement, mediastinal mass, T-cell phenotype, testicular involvement, or poor prednisone response.
ALL2013 included 174 patients (106 SR and 68 HR) and ALL2016 188 (91 SR and 97 HR). Although the number of HR patients was significantly higher in ALL2016 (51.6% vs. 39.1%; p = .017), the outcome of ALL2016 improved over ALL2013 (4-year-probable overall survival (pOS) 60.1% vs. 50.0%; p = .042 and 4-year-probable event-free survival (pEFS) 49.5% vs. 36.8%; p = .018). ALL2016 showed a nonsignificant advantage for SR patients (4-year-pEFS 56.0% vs. 47.2%; p = .220 and 4-year-pOS 70.3% vs. 61.3%; p = .166), but less toxic deaths (7% vs. 20%; p = .011). In HR group, the outcomes were significantly better in ALL2016 (4-year-pEFS 43.3% vs. 20.6%; p = .004; 4-year-pOS 50.5% vs. 32.4%; p = .014) especially due to less relapses (31% vs. 62%; p = .001). Isolated CNS relapses went down from 18 to 8% in HR (p = .010) and 11 to 5% in SR (p = .474). Both SR and HR showed lower numbers of abandonment in ALL2016 (6% vs. 14%; p = .039).
Overall ALL2016 results improved over ALL2013. Modest changes in protocol resulted in less initial toxicity and abandonments.
印度尼西亚作为一个中低收入国家，儿童急性淋巴细胞白血病（ALL）的预后低于高收入国家。印尼ALL2013方案导致了过多的毒性死亡（21%）和治疗中断（11%）。因此，我们起草了一个适应性方案ALL2016。主要变化：标准风险（SR）组不使用蒽环类药物，高危（HR）组诱导期泼尼松替换为地塞米松，HR组蒽环类药物和环磷酰胺重新安排使用时间。
患者（年龄1 - 18岁）被分为SR组和HR组。HR的定义为年龄超过10岁、白细胞计数超过50×10⁹/L、中枢神经系统（CNS）受累、纵隔肿块、T细胞表型、睾丸受累或泼尼松反应不佳。
ALL2013纳入174例患者（106例SR组和68例HR组），ALL2016纳入188例（91例SR组和97例HR组）。尽管ALL2016中HR患者数量显著增加（51.6%对39.1%；p = 0.017），但ALL2016的结局优于ALL2013（4年预计总生存率（pOS）60.1%对50.0%；p =
