MULTIMODAL THERAPY FOR THE MANAGEMENT OF NONPELVIC, LOCALIZED EWINGS-SARCOMA OF BONE - INTERGROUP STUDY IESS-II
MULTIMODAL THERAPY FOR THE MANAGEMENT OF NONPELVIC, LOCALIZED EWINGS-SARCOMA OF BONE - INTERGROUP STUDY IESS-II
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DOI：
10.1200/jco.1990.8.9.1514
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发表时间：
1990-09-01
影响因子：
45.3
通讯作者：
GILULA, L
中科院分区：
文献类型：
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作者：
BURGERT, EO;NESBIT, ME;GILULA, L
214例符合条件的既往未经治疗的局限性骨尤文氏肉瘤患者在IESS-II中随机接受阿霉素（ADR;多柔比星; Adria Laboratories，哥伦布，OH）、环磷酰胺、长春新碱和更生霉素，采用高剂量间歇法（治疗[trt] 1）或中等剂量连续法（trt 2），类似于IESS-I的四种药物组。在登记时对患者特征（性别、原发部位、手术类型）进行分层;这些和其他患者特征（年龄、从症状到诊断的时间、人种）在治疗组之间的分布相似。鼓励手术切除，但不是强制性的。局部放射治疗与IESS-I相同。中位随访时间为5.6年。治疗1组的总体结局明显好于治疗2组。5年时，无疾病、无复发和存活的患者百分比估计值分别为68%、73%和77%（治疗1）和48%、56%和63%（治疗2）（P分别为0.02、0.03和0.05）。两个治疗组治疗失败的主要原因是发生转移性疾病。肺是最常见的转移部位，其次是骨部位。治疗组之间重度或更严重毒性的合并发生率（67%）相当;然而，治疗1时重度或更严重心血管毒性显著更高。唯一的治疗相关死亡（N = 3）发生在治疗1，与心脏相关。
Two hundred fourteen eligible patients with previously untreated, localized Ewing''s sarcoma of bone were randomized on IESS-II to receive Adriamycin (ADR; doxorubicin; Adria Laboratories, Columbus, OH), cyclophosphamide, vincristine, and dactinomycin by either a high-dose intermittent method (treatment [trt] 1) or a moderate-dose continuous method (trt 2) similar to the four-drug arm of IESS-I. Patient characteristics (sex, primary site, type of surgery) were stratified at the time of registration; these and other patient characteristics (age, time from symptoms to diagnosis, race) were distributed similarly between treatments. Surgical resection was encouraged, but not mandatory. Local radiation therapy was the same as for IESS-I. The median follow-time is 5.6 years. The overall outcome was significantly better on trt 1 than on trt 2. At 5 years, the estimated percentages of patients who were disease-free, relapse-free, and surviving were 68%, 73%, and 77% for trt 1 and 48%, 56%, and 63% for trt 2 (P = .02, .03, and .05, respectively). The major reason for treatment failure for both treatment groups was the development of metastatic disease. The lung was the most common site of metastases followed by bone sites. The combined incidence of severe or worse toxicity (67%) was comparable between the treatments; however, severe or worse cardiovascular toxicity was significantly greater on trt 1. The only treatment-associated deaths (N = 3) were on trt 1 and were cardiac-related.