Comparison between single-dose and divided-dose administration of dactinomycin and doxorubicin for patients with Wilms' tumor: A report from the national Wilms' Tumor Study Group
Comparison between single-dose and divided-dose administration of dactinomycin and doxorubicin for patients with Wilms' tumor: A report from the national Wilms' Tumor Study Group
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DOI：
10.1200/jco.1998.16.1.237
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发表时间：
1998-01-01
影响因子：
45.3
通讯作者：
D'Angio, GJ
中科院分区：
文献类型：
--
作者：
Green, DM;Breslow, NE;D'Angio, GJ
目的：国家肾母细胞瘤研究（NWTS）-4被设计为评估用于治疗肾母细胞瘤（WT）的不同方案的功效、毒性和施用成本。1986年8月6日至1994年9月1日，1，687例既往未经治疗的16岁以下I至II期/组织学良好（FH）或I期/间变性组织学WT儿童（低风险[LR]组）或III期至N/FH WT或I期至IV期/肾透明细胞肉瘤（高风险[HR]组）被随机分配至包括长春新碱和放线菌素分次给药（标准[STD]）疗程（5天）或单次给药（脉冲强化[PI]）的治疗。HR患者还接受了STD疗程（3天）或PI治疗与阿霉素。结果：LR患者的2年无复发生存率（RFS）为91.3%，544例随机分配到PI治疗和91.4%，556例随机分配到STD化疗（P = 0.988）。HR患者的2年RFS率为87.3%，299例随机分配到PI治疗组，288例随机分配到STD化疗组为90.0%（P = 0.865）。结论：我们得出结论，接受PI联合化疗治疗LR或HR WT或肾透明细胞肉瘤的患者的2年RFS与接受STD方案治疗的患者相同。基于已证实的疗效、更大的给药剂量强度、更低的严重血液学毒性以及更少的医生和医院就诊要求，建议将PI药物给药作为新标准。(C)1998年，美国临床肿瘤学会。
Purpose: The National Wilms' Tumor Study (NWTS)-4 was designed to evaluate the efficacy toxicity, and cost of administration of different regimens for the treatment of Wilms' tumor (WT).Patients and Methods: Between August 6, 1986 and September 1, 1994, 1,687 previously untreated children less than 16 years of age with stages I to II/favorable histology (FH) or stage I/anaplastic histology WT (low-risk [LR] group) or stages III to N/FH WT or stages I to IV/clear cell sarcoma of the kidney (high-risk [HR] group) were randomized to treatment that included vincristine and either divided-dose (standard [STD]) courses (5 days) or single dose (pulse-intensive [PI]) treatment with dactinomycin. HR patients also received either STD courses (3 days) or PI treatment with doxorubicin.Results: The 2-year relapse-free survival (RFS) rates for LR patients were 91.3% for 544 randomized to treatment with PI and 91.4% for 556 randomized to treatment with STD chemotherapy (P = .988). The 2-year RFS rates for HR Patients were 87.3% for 299 randomized to treatment with PI and 90.0% for 288 randomized to treatment with STD chemotherapy (P = .865).Conclusion: We conclude that patients treated with PI combination chemotherapy for LR or HR WT or clear cell sarcoma of the kidney have equivalent 2-year RFS to those treated with STD regimens. PI drug administration is recommended as the new standard based on demonstrated efficacy, greater administered dose-intensity, less severe hematologic toxicity, and the requirement for fewer physician and hospital encounters. (C) 1998 by American Society of Clinical Oncology.