Phase II study of neoadjuvant chemotherapy and radiation therapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation therapy oncology group trial 9514
Phase II study of neoadjuvant chemotherapy and radiation therapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation therapy oncology group trial 9514
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DOI：
10.1200/jco.2005.02.5577
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发表时间：
2006-02-01
影响因子：
45.3
通讯作者：
Eiaberg, B
中科院分区：
文献类型：
--
作者：
Kraybill, WG;Harris, J;Eiaberg, B
在一项阳性的单机构试点研究的基础上，放射治疗肿瘤组启动了II期试验9514，以评估其在多机构组间环境下的非辅助治疗方案。患者和方法入选：四肢和体壁高级别软组织肉瘤>= 8cm直径。患者接受3个周期的新辅助化疗（CT、改良mesna、阿霉素、异环磷酰胺、达卡巴嗪[MAID]），术前交叉放疗（RT, 44 Gy，分疗程给药），术后3个周期CT（改良MAID）。结果纳入66例患者，其中64例进行分析。79%的患者完成了术前CT检查，59%的患者完成了所有计划的CT检查。3例患者（5%）出现致命的5级毒性（骨髓增生异常2例；感染1例）。另有53名患者（83%）出现4级毒性；78%经历了4级血液毒性，19%经历了4级非血液毒性。61名患者接受了手术。其中58例为R0切除，其中5例为截肢。有三个R1切除。如果截肢被认为是失败，估计3年内局部区域的失败率为17.6%，如果不被认为是失败，则为10.1%。估计3年无病、远端无病和总生存率分别为56.6%、64.5%和75.1%。结论该联合治疗方法可在多机构环境下成功实施。疗效结果与以往单一机构的结果一致。
Purpose On the basis of a positive reported single-institution pilot study, the Radiation Therapy Oncology Group initiated phase II trial 9514 to evaluate its necradjuvant regimen in a multi-institutional Intergroup setting.Patients and Methods Eligibility included a high-grade soft tissue sarcoma >= 8 cm in diameter of the extremities and body wall. Patients received three cycles of neoadjuvant chemotherapy (CT; modified mesna, doxorubicin, ifosfamide, and dacarbazine [MAID]), intercligitated preoperative radiation therapy (RT; 44 Gy administered in split courses), and three cycles of postoperative CT (modified MAID).Results Sixty-six patients were enrolled, of whom 64 were analyzed. Seventy-nine percent of patients completed their preoperative CT and 59% completed all planned CT. Three patients (5%) experienced fatal grade 5 toxicities (myelodysplasias, two patients;, infection, one patient). Another 53 patients (83%) experienced grade 4 toxicities; 78% experienced grade 4 hematologic toxicity and 19% experienced grade 4 nonhematologic toxicity. Sixty-one patients underwent surgery. Fifty-eight of these were R0 resections, of which five were amputations. There were three R1 resections. The estimated 3-year rate for local-regional failure is 17.6% if amputation is considered a failure and 10.1% if not. Estimated 3-year rates for disease-free, distant-disease-free, and overall survival are 56.6%, 64.5%, and 75.1%, respectively.Conclusion This combined-modality treatment can be delivered successfully in a multi-institutional setting. Efficacy results are consistent with previous single-institution results.