Childhood acute lymphoblastic leukemia: Four years evaluation of protocols 2013 and 2016 in a single center in Indonesia, a lower-middle-income country
Corresponding Author
Sutaryo Sutaryo
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Correspondence
Sutaryo S, Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia, Jl. Kesehatan No.1, Sleman, DI Yogyakarta, Indonesia.
Email: [email protected]
Search for more papers by this authorPudjo Hagung Widjajanto
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorSri Mulatsih
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorBambang Ardianto
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorAlexandra Widita Swipratami Pangarso
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorEddy Supriyadi
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorIgnatius Purwanto
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorClaudia Priska Adelin
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorRahmadani Puji Lestari
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorLintang Sagoro
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorScholastika Dita Christian
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorDea Sella Sabrina
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorNatasha Verena
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorWijnanda Adriana Kors
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
Search for more papers by this authorGertjan J. L. Kaspers
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
Department of Pediatric Oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Search for more papers by this authorAnjo J. P. Veerman
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Department of Pediatric Oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Search for more papers by this authorCorresponding Author
Sutaryo Sutaryo
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Correspondence
Sutaryo S, Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia, Jl. Kesehatan No.1, Sleman, DI Yogyakarta, Indonesia.
Email: [email protected]
Search for more papers by this authorPudjo Hagung Widjajanto
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorSri Mulatsih
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorBambang Ardianto
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorAlexandra Widita Swipratami Pangarso
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorEddy Supriyadi
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorIgnatius Purwanto
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorClaudia Priska Adelin
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorRahmadani Puji Lestari
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorLintang Sagoro
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorScholastika Dita Christian
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorDea Sella Sabrina
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorNatasha Verena
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Search for more papers by this authorWijnanda Adriana Kors
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
Search for more papers by this authorGertjan J. L. Kaspers
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
Department of Pediatric Oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Search for more papers by this authorAnjo J. P. Veerman
Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr Sardjito Hospital, Yogyakarta, Indonesia
Department of Pediatric Oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Search for more papers by this author[Correction added on 11 August 2022 after online publication: First names and surnames have been corrected for all the authors except the author Scholastika Dita Christian].
Abstract
Background
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.
Procedure
Patients (aged: 1–18 years) were stratified into SR and HR. HR was defined as age over 10 years, leucocyte count over 50 × 109/L, central nervous system (CNS) involvement, mediastinal mass, T-cell phenotype, testicular involvement, or poor prednisone response.
Results
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).
Conclusions
Overall ALL2016 results improved over ALL2013. Modest changes in protocol resulted in less initial toxicity and abandonments.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
Open Research
DATA AVAILABILITY STATEMENT
Data available on request due to privacy/ethical restrictions.
Supporting Information
| Filename | Description |
|---|---|
| pbc29875-sup-0001-FigureS1.png1.1 MB | SUPPLEMENTAL FIGURE S1. Standard Risk ALL 2013 protocol |
| pbc29875-sup-0002-FigureS2.png1 MB | SUPPLEMENTAL FIGURE S2. High Risk ALL 2013 Protocol |
| pbc29875-sup-0003-FigureS3.png1.2 MB | SUPPLEMENTAL FIGURE S3. Standard Risk ALL 2016 protocol |
| pbc29875-sup-0004-FigureS4.png1.2 MB | SUPPLEMENTAL FIGURE S4. High Risk ALL 2016 Protocol |
| pbc29875-sup-0005-FigureS5.jpg287.2 KB | SUPPLEMENTAL FIGURE S5. Kaplan Meier Curves of Cumulative Incidence of Relapse ALL 2013 vs ALL 2016 |
| pbc29875-sup-0006-FigureS6.jpg395.8 KB | SUPPLEMENTAL FIGURE S6. Kaplan Meier Curves of Cumulative Incidence of Relapse SR and HR Group ALL 2013 vs ALL 2016 |
| pbc29875-sup-0007-FigureS7.jpg316 KB | SUPPLEMENTAL FIGURE S7. Kaplan Meier Curves of Cumulative Incidence of Isolated Bone Marrow Relapse ALL 2013 vs ALL 2016 |
| pbc29875-sup-0008-FigureS8.jpg388.3 KB | SUPPLEMENTAL FIGURE S8. Kaplan Meier Curves of Cumulative Incidence of Isolated BM Relapse SR and HR Group ALL 2013 vs ALL 2016 |
| pbc29875-sup-0009-FigureS9.jpg297.5 KB | SUPPLEMENTAL FIGURE S9. Kaplan Meier Curves of Cumulative Incidence of Isolated CNS Relapse ALL 2013 vs ALL 2016 |
| pbc29875-sup-0010-FigureS10.jpg356.9 KB | SUPPLEMENTAL FIGURE S10. Kaplan Meier Curves of Cumulative Incidence of Isolated CNS Relapse SR and HR Group ALL 2013 vs ALL 2016 |
| pbc29875-sup-0011-FigureS11.jpg292.6 KB | SUPPLEMENTAL FIGURE S11. Kaplan Meier Curves of Cumulative Incidence of Death ALL 2013 vs ALL 2016 |
| pbc29875-sup-0012-FigureS12.jpg384.3 KB | SUPPLEMENTAL FIGURE S12. Kaplan Meier Curves of Cumulative Incidence of Death SR and HR Group ALL 2013 vs ALL 2016 |
| pbc29875-sup-0013-FigureS13.jpg321 KB | SUPPLEMENTAL FIGURE S13. Kaplan Meier Curves of Cumulative Incidence of Abandonment ALL 2013 vs ALL 2016 |
| pbc29875-sup-0014-FigureS14.jpg377.9 KB | SUPPLEMENTAL FIGURE S14. Kaplan Meier Curves of Cumulative Incidence of Abandonment SR and HR Group ALL 2013 vs ALL 2016 |
| pbc29875-sup-0015-FigureS15.png144 KB | SUPPLEMENTAL FIGURE S15. (A) Timeline of first event in SR Group ALL 2013; (B) Timeline of first event in SR Group ALL 2016 |
| pbc29875-sup-0016-FigureS16.png170 KB | SUPPLEMENTAL FIGURE S16. (A) Timeline of first event in HR Group ALL 2013; (B) Timeline of first event in HR Group ALL 2016 |
| pbc29875-sup-0017-TableS1.docx13.9 KB | SUPPLEMENTAL TABLE 1. Table of differences between ALL 2013 and ALL 2016 protocol |
| pbc29875-sup-0018-TableS2.docx15 KB | SUPPLEMENTAL TABLE S2. Results of Kaplan Meier Curves of 4-year-pEFS and 4-year-pOS ALL 2013 and ALL 2016 |
| pbc29875-sup-0019-TableS3.docx25 KB | SUPPLEMENTAL TABLE S3. Clinical response (actuarial data) |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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