Ettinger L J, Ivy P, Gaynon P S, Ettinger A G, Liu-Mares W, Krailo M D
Department of Pediatrics, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, USA.
Cancer. 1997 Jul 15;80(2):311-6.
Carboplatin is an analogue of cisplatin with less nonhematologic toxicity and a similar spectrum of antineoplastic activity. Although cisplatin has not been found to be an active agent against leukemia, carboplatin-induced complete remissions have been observed in adults with acute myelogenous leukemia (AML), and antileukemic activity has been observed in a Phase I trial involving children with acute lymphoblastic leukemia (ALL) and AML. Therefore, a pediatric Phase II study was undertaken to determine the degree of activity of carboplatin in childhood ALL and AML.
Between October 1991 and November 1994, the Children's Cancer Group conducted a Phase II study of carboplatin given by 5-day continuous intravenous infusion to children with acute leukemia recurring in bone marrow.
Minimal antileukemic activity was demonstrated in patients with ALL and AML. One of 21 eligible patients with ALL achieved a partial response. Of 23 eligible patients with AML, including 1 patient with chronic myelogenous leukemia in blast crisis, 1 had hypocellular M1 bone marrow with a platelet count of 15,000/mm3, and 2 achieved partial responses. Nonhematologic toxicities, which were infrequent, included mild hepatic and renal dysfunction.
In this pediatric Phase II trial of carboplatin as a treatment for acute leukemia, minimal activity was demonstrated in patients with ALL and AML recurring in bone marrow. Further evaluation of carboplatin as a treatment for childhood leukemia, using the dose schedule of 216 mg/m2/day given by 5-day continuous intravenous infusion, does not appear warranted.
卡铂是顺铂的类似物，非血液学毒性较小，抗肿瘤活性谱相似。虽然尚未发现顺铂对白血病有效，但在成人急性髓性白血病（AML）患者中已观察到卡铂诱导的完全缓解，并且在一项涉及急性淋巴细胞白血病（ALL）和AML儿童的I期试验中观察到了抗白血病活性。因此，开展了一项儿科II期研究，以确定卡铂在儿童ALL和AML中的活性程度。
1991年10月至1994年11月期间，儿童癌症研究组对骨髓复发的急性白血病儿童进行了一项卡铂为期5天持续静脉输注的II期研究。
ALL和AML患者显示出最小的抗白血病活性。21例符合条件的ALL患者中有1例获得部分缓解。在23例符合条件的AML患者中，包括1例处于急变期的慢性髓性白血病患者，1例骨髓细胞减少的M1型患者，血小板计数为15,000/mm3，2例获得部分缓解。非血液学毒性不常见，包括轻度肝肾功能不全。
在这项将卡铂作为急性白血病治疗方法的儿科II期试验中，骨髓复发的ALL和AML患者显示出最小的活性。使用216mg/m2/天的剂量方案进行为期5天的持续静脉输注，进一步评估卡铂作为儿童白血病的治疗方法似乎没有必要。
