Kraybill William G, Harris Jonathon, Spiro Ira J, Ettinger David S, DeLaney Thomas F, Blum Ronald H, Lucas David R, Harmon David C, Letson G Douglas, Eisenberg Burton
Department of Surgical Oncology, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
J Clin Oncol. 2006 Feb 1;24(4):619-25. doi: 10.1200/JCO.2005.02.5577.
On the basis of a positive reported single-institution pilot study, the Radiation Therapy Oncology Group initiated phase II trial 9514 to evaluate its neoadjuvant regimen in a multi-institutional Intergroup setting.
Eligibility included a high-grade soft tissue sarcoma > or = 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]), interdigitated preoperative radiation therapy (RT; 44 Gy administered in split courses), and three cycles of postoperative CT (modified MAID).
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.
This combined-modality treatment can be delivered successfully in a multi-institutional setting. Efficacy results are consistent with previous single-institution results.
基于一项已报道的单机构阳性试点研究，放射肿瘤学组启动了II期试验9514，以在多机构的协作组环境中评估其新辅助治疗方案。
入选标准包括直径≥8 cm的四肢及体壁高级别软组织肉瘤。患者接受三个周期的新辅助化疗（CT；改良美司钠、多柔比星、异环磷酰胺和达卡巴嗪[MAID]）、术前交叉放疗（RT；分程给予44 Gy）以及三个周期的术后CT（改良MAID）。
共纳入66例患者，其中64例进行了分析。79%的患者完成了术前CT，59%的患者完成了所有计划的CT。3例患者（5%）发生致命的5级毒性反应（骨髓发育异常，2例；感染，1例）。另外53例患者（83%）发生4级毒性反应；78%的患者发生4级血液学毒性反应，19%的患者发生4级非血液学毒性反应。61例患者接受了手术。其中58例为R0切除，其中5例为截肢。有3例R1切除。如果将截肢视为失败，则局部区域复发的估计3年发生率为17.6%；如果不视为失败，则为10.1%。无病生存、远处无病生存和总生存的估计3年发生率分别为56.6%、64.5%和75.1%。
这种综合治疗模式可在多机构环境中成功实施。疗效结果与之前的单机构结果一致。
