Effectiveness and Safety of Clofarabine Monotherapy or Combination Treatment in Relapsed/Refractory Childhood Acute Lymphoblastic Leukemia: A Pragmatic, Non-interventional Study in Korea
- Authors
- 최정윤; 홍채리; 홍경택; 강형진; 김성구; 이재욱; 장필상; 정낙균; 조빈; 김혜리; 고경남; 임호준; 서종진; 한승민; 한정우; 류철주; 양유진; 임영탁; 유건희; 구홍회; 국훈; 전인상; 조하나; 신희영
- Issue Date
- Oct-2021
- Publisher
- 대한암학회
- Keywords
- Acute lymphoblastic leukemia; Clofarabine; Leukemia; Pediatric malignancy; Pediatric cancer
- Citation
- Cancer Research and Treatment, v.53, no.4, pp.1184 - 1194
- Journal Title
- Cancer Research and Treatment
- Volume
- 53
- Number
- 4
- Start Page
- 1184
- End Page
- 1194
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/83402
- DOI
- 10.4143/crt.2020.289
- ISSN
- 1598-2998
- Abstract
- Purpose Effectiveness and safety of clofarabine (one of the treatment mainstays in pediatric patients with relapsed/refractory acute lymphoblastic leukemia [ALL]) was assessed in Korean pediatric patients with ALL to facilitate conditional coverage with evidence development.
Materials and Methods In this multicenter, prospective, observational study, patients receiving clofarabine as mono/combination therapy were followed up every 4-6 weeks for 6 months or until hematopoietic stem cell transplantation (HSCT). Response rates, survival outcomes, and adverse events were assessed.
Results Sixty patients (2-26 years old; 65% B-cell ALL, received prior ≥ 2 regimen, 68.3% refractory to previous regimen) were enrolled and treated with at least one dose of clofarabine; of whom 26 (43.3%) completed 6 months of follow-up after the last dose of clofarabine. Fifty-eight patients (96.7%) received clofarabine combination therapy. Overall remission rate (complete remission [CR] or CR without platelet recovery [CRp]) was 45.0% (27/60; 95% confidence interval [CI], 32.4 to 57.6) and the overall response rate (CR, CRp, or partial remission [PR]) was 46.7% (28/60; 95% CI, 34.0 to 59.3), with 11 (18.3%), 16 (26.7%), and one (1.7%) patients achieving CR, CRp, and PR, respectively. The median time to remission was 5.1 weeks (95% CI, 4.7 to 6.1). Median duration of remission was 16.6 weeks (range, 2.0 to 167.6 weeks). Sixteen patients (26.7%) proceeded to HSCT. There were 24 deaths; 14 due to treatment-emergent adverse events.
Conclusion Remission with clofarabine was observed in approximately half of the study patients who had overall expected safety profile; however, there was no favorable long-term survival outcome in this study.
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