随机对照试验研究间隔压缩化疗治疗局限性尤因肉瘤：儿童肿瘤协作组的报告。
Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group.
机构信息
Division of Oncology, CTRB 10, The Children's Hospital of Philadelphia, University of Pennsylvania, 3501 Civic Center Blvd, Philadelphia, PA 19104, USA.
出版信息
J Clin Oncol. 2012 Nov 20;30(33):4148-54. doi: 10.1200/JCO.2011.41.5703. Epub 2012 Oct 22.
PURPOSE
Chemotherapy with alternating vincristine-doxorubicin-cyclophosphamide and ifosfamide-etoposide cycles and primary tumor treatment with surgery and/or radiation therapy constitute the usual approach to localized Ewing sarcoma in North America. We tested whether chemotherapy intensification through interval compression could improve outcome.
PATIENTS AND METHODS
This was a prospective, randomized controlled trial for patients younger than 50 years old with newly diagnosed localized extradural Ewing sarcoma. Patients assigned to standard and intensified treatment were to begin chemotherapy cycles every 21 and 14 days, respectively, provided an absolute neutrophil count greater than 750×10(6)/L and a platelet count greater than 75×10(9)/L. Patients received vincristine (2 mg/m2), doxorubicin (75 mg/m2), and cyclophosphamide (1.2 g/m2) alternating with ifosfamide (9 g/m2) and etoposide (500 mg/m2) for 14 cycles, with filgrastim (5 mg/kg per day; maximum, 300 mg) between cycles. Primary tumor treatment (surgery, radiation, or both) was to begin at week 13 (after four cycles in the standard arm and six cycles in the intensified arm). The primary end point was event-free survival (EFS). The study is registered at ClinicalTrials.gov (identifier: NCT00006734).
RESULTS
Five hundred eighty-seven patients were enrolled and randomly assigned, and 568 patients were eligible, with 284 patients in each regimen. For all cycles, the median cycle interval for standard treatment was 21 days (mean, 22.45 days); for intensified treatment, the median interval was 15 days (mean, 17.29 days). EFS at a median of 5 years was 65% in the standard arm and 73% in the intensified arm (P=.048). The toxicity of the regimens was similar.
CONCLUSION
For localized Ewing sarcoma, chemotherapy administered every 2 weeks is more effective than chemotherapy administered every 3 weeks, with no increase in toxicity.
目的
长春新碱-多柔比星-环磷酰胺和异环磷酰胺-依托泊苷交替化疗，并辅以手术和/或放疗治疗原发性肿瘤，这是北美局限性尤因肉瘤的常用治疗方法。我们研究了通过间隔压缩来强化化疗是否能改善疗效。
患者和方法
这是一项针对 50 岁以下新诊断的局限性硬膜外尤因肉瘤患者的前瞻性、随机对照试验。标准治疗组和强化治疗组的患者分别在中性粒细胞绝对计数>750×106/L 和血小板计数>75×109/L 时，每 21 天和 14 天开始化疗周期。患者接受长春新碱（2 mg/m2）、多柔比星（75 mg/m2）和环磷酰胺（1.2 g/m2）交替使用异环磷酰胺（9 g/m2）和依托泊苷（500 mg/m2），共 14 个周期，在每个周期之间给予非格司亭（5 mg/kg/天；最大剂量 300 mg）。在第 13 周（标准组 4 个周期后和强化组 6 个周期后）开始进行原发性肿瘤治疗（手术、放疗或两者联合）。主要终点是无事件生存（EFS）。该研究在 ClinicalTrials.gov 注册（标识符：NCT00006734）。
结果
共纳入并随机分配了 587 例患者，其中 568 例患者符合条件，每组 284 例。所有周期中，标准治疗的中位周期间隔为 21 天（平均 22.45 天）；强化治疗的中位间隔为 15 天（平均 17.29 天）。中位随访 5 年后，标准组的 EFS 为 65%，强化组为 73%（P=0.048）。两种方案的毒性相似。
结论
对于局限性尤因肉瘤，每 2 周给予化疗比每 3 周给予化疗更有效，且毒性没有增加。
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