Department of Pediatric Hematology and Oncology, University Children's Hospital of Muenster, Muenster, Germany.
Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
Leuk Lymphoma. 2020 Jan;61(1):138-145. doi: 10.1080/10428194.2019.1658099. Epub 2019 Sep 3.
The GMALL07/2003 protocol introduced pegylated asparaginase (PEG-ASNase) frontline for adults with acute lymphoblastic leukemia (ALL). PEG-ASNase (500 U/m, 1000 U/m, or 2000 U/m) was given once in induction and as part of three HD-MTX/PEG-ASNase cycles with two PEG-ASNase doses every other week in consolidation. PEG-ASNase activities were monitored in 1363 serum samples from 304 ALL patients. The overall rate of silent inactivation was low (5%) and did not differ between induction and consolidation. The successful targeting of PEG-ASNase activities ≥100 U/L depended on protocol and dose. Overall PEG-ASNase activities were higher during consolidation compared to induction. To target PEG-ASNase activities ≥100 U/L for 14 day with a single dose in induction, 2000 U/m was more preferable than 1000 U/m or 500 U/m. During consolidation with two administrations every other week, 1000 U/m and 2000 U/m were similarly effective in sustaining PEG-ASNase ≥100 U/L activities over 14 days.
GMALL07/2003 方案将聚乙二醇化天冬酰胺酶(PEG-ASNase)引入急性淋巴细胞白血病(ALL)成人患者的一线治疗。PEG-ASNase(500 U/m、1000 U/m 或 2000 U/m)在诱导期单次给予,并在强化期进行三个 HD-MTX/PEG-ASNase 周期,每两周给予两次,每次给予 2 剂 PEG-ASNase。在 304 例 ALL 患者的 1363 份血清样本中监测了 PEG-ASNase 活性。总的沉默失活率较低(5%),且在诱导期和强化期之间没有差异。成功靶向 PEG-ASNase 活性≥100 U/L 取决于方案和剂量。与诱导期相比,强化期的 PEG-ASNase 活性总体更高。为了在诱导期单次给予时使 PEG-ASNase 活性≥100 U/L 持续 14 天,2000 U/m 比 1000 U/m 或 500 U/m 更可取。在强化期每两周给予两次时,1000 U/m 和 2000 U/m 在维持 PEG-ASNase≥100 U/L 活性超过 14 天方面同样有效。