Packer R J, Lange B, Ater J, Nicholson H S, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles M N
Department of Neurology, Children's National Medical Center, Washington, DC 20010.
J Clin Oncol. 1993 May;11(5):850-6. doi: 10.1200/JCO.1993.11.5.850.
This study investigates the response rate to and toxicity of carboplatin and vincristine in children with recurrent low-grade gliomas (LGGs) or patients younger than 60 months with newly diagnosed LGGs.
Twenty-three children with recurrent and 37 children with newly diagnosed LGGs were treated with a 10-week induction cycle of carboplatin and vincristine, followed by maintenance treatment with the same drugs. Patients were evaluated for response to treatment and toxicity.
Twelve of 23 (52% +/- 10%; 95% confidence interval [CI], 0.32 to 0.72) assessable children with recurrent disease had an objective response to treatment, which included a greater than 50% reduction in tumor size in seven of 23 (30% +/- 10%; 95% CI, 0.10 to 0.50). Twenty-three of 37 (62% +/- .08; 95% CI, 0.46 to 0.78) of newly diagnosed patients had an objective response, 16 of 37 (43% +/- 0.08%; 95% CI, 0.27 to 0.59) with greater than 50% reduction in tumor size. The majority of those with an objective response had diencephalic tumors (n = 29), but children with thalamic (n = 2), cortical (n = 1), and brain stem (n = 2) LGGs also responded to treatment. Of the 35 patients with objective response to treatment, the maximum response was seen in 25 after completion of induction and in the remaining 10 after two to six cycles of maintenance treatment. Forty-nine of 53 (92% +/- .04%) patients who were stable or improved after induction remain without progressive disease (PD). Hematologic toxicity was common, but resulted in cessation of therapy in only one patient. Six children have been removed from the study because of allergic reactions, which were considered to be carboplatin-associated.
Carboplatin and vincristine have activity in children with recurrent and newly diagnosed progressive LGGs. Objective responses to treatment after chemotherapy can be seen. This drug regimen is relatively well tolerated, and further studies are indicated to define the role of this combination of drugs in children with newly diagnosed LGGs.
本研究调查卡铂和长春新碱对复发性低级别胶质瘤（LGG）患儿或60个月以下新诊断LGG患儿的缓解率及毒性。
23例复发性LGG患儿和37例新诊断LGG患儿接受了为期10周的卡铂和长春新碱诱导治疗周期，随后用相同药物进行维持治疗。对患者的治疗反应和毒性进行评估。
23例可评估的复发性疾病患儿中有12例（52%±10%；95%置信区间[CI]，0.32至0.72）对治疗有客观反应，其中23例中有7例（30%±10%；95%CI，0.10至0.50）肿瘤大小缩小超过50%。37例新诊断患者中有23例（62%±0.08；95%CI，0.46至0.78）有客观反应，37例中有16例（43%±0.08%；95%CI，0.27至0.59）肿瘤大小缩小超过50%。大多数有客观反应的患者患有间脑肿瘤（n = 29），但丘脑（n = 2）、皮质（n = 1）和脑干（n = 2）LGG患儿也对治疗有反应。在35例对治疗有客观反应的患者中，25例在诱导治疗完成后出现最大反应，其余10例在维持治疗两至六个周期后出现最大反应。53例诱导治疗后病情稳定或改善的患者中有49例（92%±0.04%）无疾病进展（PD）。血液学毒性很常见，但仅导致一名患者停止治疗。6名儿童因过敏反应退出研究，这些反应被认为与卡铂有关。
卡铂和长春新碱对复发性和新诊断的进展性LGG患儿有活性。化疗后可观察到对治疗的客观反应。该药物方案耐受性相对良好，需要进一步研究以确定这种药物组合在新诊断LGG患儿中的作用。
