RANDOMIZED PHASE-III TRIAL IN CHILDHOOD HIGH-GRADE ASTROCYTOMA COMPARING VINCRISTINE, LOMUSTINE, AND PREDNISONE WITH THE 8-DRUGS-IN-1-DAY REGIMEN
RANDOMIZED PHASE-III TRIAL IN CHILDHOOD HIGH-GRADE ASTROCYTOMA COMPARING VINCRISTINE, LOMUSTINE, AND PREDNISONE WITH THE 8-DRUGS-IN-1-DAY REGIMEN
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DOI：
10.1200/jco.1995.13.1.112
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发表时间：
1995-01-01
影响因子：
45.3
通讯作者：
PACKER, RJ
中科院分区：
文献类型：
--
作者：
FINLAY, JL;BOYETT, JM;PACKER, RJ
目的：在之前的一项随机试验中，在术后放疗的基础上增加辅助化疗被证明对儿童高级别星形细胞瘤的治疗有益。本研究验证了一个假设，即与先前研究的三药方案相比，八药辅助化疗方案可以提高这类儿童的生存率。患者和方法：1985年4月至1990年5月，年龄在18个月至21岁之间的新诊断为高级别星形细胞瘤的患者符合本研究的条件，由治疗机构的组织病理学诊断确定。治疗包括术后局部野放疗和辅助化疗，洛莫司汀（CCNU）、长春新碱、强的松（对照方案）或1天8药化疗（实验方案）。实验方案术后放疗前化疗2个周期。放疗后每3个月对患者进行影像学评估。结果：85例符合条件的患者随机分为对照方案，87例分为实验方案。5年无进展生存率（PFS）和总生存率（OS）分别为33% （SE = 5%）和36% （SE = 6%）。两种化疗方案的结果无统计学差异。在确诊为间变性星形细胞瘤（AA）或多形性胶质母细胞瘤（GEM）的患者中，间变性星形细胞瘤、大于90%的切除和非中线肿瘤位置是PFS改善的预测特征。两种化疗方案的毒性有所不同，实验方案的骨髓抑制和听力损失更大。肿瘤复发主要发生在原发肿瘤部位。结论：与CCNU、长春新碱和强的松相比，1天8药化疗对儿童高恶性星形细胞瘤的治疗没有任何益处。肿瘤切除范围和组织病理学诊断是影响预后的重要因素。儿童高级别星形细胞瘤的总体预后仍然很差。
Purpose: In a previous randomized trial, the addition of adjuvant chemotherapy to postoperative radiotherapy proved beneficial in the treatment of childhood high-grade astrocytomas. The present study tests the hypothesis sis that an eight-drug adjuvant chemotherapy regimen would improve survival in such children compared with the three-drug regimen of the prior study.Patients and Methods: Between April 1985 and May 1990, patients between the ages of 18 months and 21 years with newly diagnosed high-grade astrocytomas were eligible for this study, as determined by the treating institution's histopathologic diagnosis. Treatment consisted of postoperative local-field radiotherapy and adjuvant chemotherapy, either lomustine (CCNU), vincristine, and prednisone (control regimen) or eight-drugs-in-1-day chemotherapy (experimental regimen). Two cycles of postoperative preirradiation chemotherapy were administered in the experimental regimen. Patients were evaluated radiographically every 3 months after irradiation.Results: Eighty-five eligible patients were randomized to the control regimen and 87 to the experimental regimen. The progression-free survival (PFS) and overall survival (OS) at 5 years were 33% (SE = 5%) and 36% (SE = 6%), respectively. There was no statistical difference in outcome between the two chemotherapy regimens. In patients with confirmed diagnoses of anaplastic astrocytoma (AA) or glioblastoma multiforme (GEM), anaplastic astrocytoma, greeter than 90% resection, and nonmidline tumor location were characteristics predictive of an improved PFS. There was a difference in toxicity between the two chemotherapeutic regimens, with greeter myelosuppression and hearing loss in the experimental regimen. Tumor recurrence occurred primarily within the primary tumor site.Conclusions: There is no benefit to the treatment of high rode astrocytomas in children with eight-drugs-in-1-day chemotherapy compared with CCNU, vincristine, and prednisone. Extent of tumor resection and histopathologic diagnosis are significant prognostic variables. The overall outcome for children with high-grade astrocytomas remains poor.