Ebeid Emad N, Kamel Magdy M, Ali Basma A
The Department of Pediatric Oncology, National Cancer Institute, Cairo University.
J Egypt Natl Canc Inst. 2008 Jun;20(2):127-33.
Asparaginase is an effective antileukemic agent which is included in most front-line protocols for pediatric acute lymphoblastic leukemia (ALL) worldwide. Since asparaginase is a bacterial protein, it may induce formation of antibodies. The reported frequency of anti-asparaginase antibodies is highly variable: antibodies have been reported in as many as 79% of adults and as many as 70% of children after intravenous or intramuscular administration of E.coli asparaginase.
The aim of this study was to determine if the presence of antibodies during induction and continuation phases in newly diagnosed children with ALL and lymphoblastic lymphoma during therapy with E.coli asparaginase, had any correlation with various factors such as: age, gender, hypersensitivity reactions, response to therapy and Event Free Survival (EFS).
Between the period from March 2005 to May 2007, sixty-four children who attended the Menia outpatient pediatric oncology clinic, or were admitted to the inpatient department of the Menia oncology center, were enrolled in the study. Forty children had newly diagnosed ALL and 24 had lymphoblastic lymphoma. Patients were 48 males (75%) and 16 females (25%) with a male:female ratio 3:1. Their ages ranged from 3.5 to 17 years with mean age of 9.6 years. All patients received asparaginase therapy according to the St. Jude Total XIII protocol, in a dose of 10,000 IU/m(2)/dose, intramuscularly for 6-9 doses during the induction phase and another 6-9 doses during continuation phase according to disease status.
Forty one patients achieved complete remission, 9 had partial remission, and 14 were lost to followup at different intervals of treatment. Antiasparaginase antibodies were detected in 36 patients (56%) out of 64 patients, and 37 patients (60%) out of 62 patients who were treated with asparaginase at day 8 and day 27 of induction phase respectively. Moreover, 33 patients (61%) out of 54 patients, and 41 patients (83%) out of 50 patients had positive antiasparaginase antibodies at week 10 and week 21 of continuation phase respectively. The 2-year EFS of the whole group was 50%. There was no statistically significant relation between positivity of antiasparaginase antibodies and the following: age, gender, hypersensitivity reaction, response to therapy and EFS.
The presence of antiasparaginase antibodies was unrelated to age, gender, hypersensitivity reaction, response to therapy and event free survival of newly diagnosed children with acute lymphoblastic leukemia and lymphoblastic lymphoma.
天冬酰胺酶是一种有效的抗白血病药物，被纳入全球大多数儿童急性淋巴细胞白血病（ALL）的一线治疗方案。由于天冬酰胺酶是一种细菌蛋白，它可能诱导抗体形成。报道的抗天冬酰胺酶抗体的发生率差异很大：静脉或肌肉注射大肠杆菌天冬酰胺酶后，多达79%的成人和多达70%的儿童体内曾有抗体报道。
本研究的目的是确定新诊断的ALL和淋巴细胞淋巴瘤患儿在接受大肠杆菌天冬酰胺酶治疗的诱导期和持续期抗体的存在是否与年龄、性别、过敏反应、治疗反应和无事件生存期（EFS）等各种因素相关。
在2005年3月至2007年5月期间，64名在梅尼亚儿科肿瘤门诊就诊或入住梅尼亚肿瘤中心住院部的儿童被纳入研究。40名儿童为新诊断的ALL，24名患有淋巴细胞淋巴瘤。患者中男性48名（75%），女性16名（25%），男女比例为3:1。年龄范围为3.5至17岁，平均年龄为9.6岁。所有患者均根据圣裘德总十三方案接受天冬酰胺酶治疗，剂量为10000IU/m²/剂量，诱导期肌肉注射6 - 9剂，持续期根据疾病状态再注射6 - 9剂。
41名患者实现完全缓解，9名部分缓解，14名在不同治疗阶段失访。64名患者中有36名（56%）检测到抗天冬酰胺酶抗体，分别在诱导期第8天和第27天接受天冬酰胺酶治疗的62名患者中有37名（60%）检测到。此外，在持续期第10周时，54名患者中有33名（61%）抗天冬酰胺酶抗体呈阳性，在第21周时，50名患者中有41名（83%）呈阳性。整个组的2年EFS为50%。抗天冬酰胺酶抗体阳性与年龄、性别、过敏反应、治疗反应和EFS之间无统计学显著关系。
抗天冬酰胺酶抗体的存在与新诊断的急性淋巴细胞白血病和淋巴细胞淋巴瘤患儿的年龄、性别、过敏反应、治疗反应和无事件生存期无关。
