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

• DOI: 10.1200/jco.2005.02.5577
• Publication Date: 2006-01-31T00:32:57Z
• Authors: William G. Kraybill; Jonathon Harris; Ira J. Spiro; David S. Ettinger; Thomas F. DeLaney; Ronald H. Blum; David R. Lucas; David C. Harmon; G. Douglas Letson; Burton Eisenberg
• Keywords: Neoadjuvant Therapy; Regimen

On the basis of a positive reported single-institution pilot study, Radiation Therapy Oncology Group initiated phase II trial 9514 to evaluate its neoadjuvant regimen in multi-institutional Intergroup setting.Eligibility included high-grade soft tissue sarcoma > or = 8 cm diameter extremities and body wall. Patients received three cycles chemotherapy (CT; modified mesna, doxorubicin, ifosfamide, dacarbazine [MAID]), interdigitated preoperative radiation therapy (RT; 44 Gy administered split courses), postoperative CT (modified MAID).Sixty-six patients were enrolled, whom 64 analyzed. Seventy-nine percent completed their 59% all planned CT. Three (5%) experienced fatal grade 5 toxicities (myelodysplasias, two patients; infection, one patient). Another 53 (83%) 4 toxicities; 78% hematologic toxicity 19% nonhematologic toxicity. Sixty-one underwent surgery. Fifty-eight these R0 resections, which five amputations. There R1 resections. The estimated 3-year rate for local-regional failure is 17.6% if amputation considered 10.1% not. Estimated rates disease-free, distant-disease-free, overall survival are 56.6%, 64.5%, 75.1%, respectively.This combined-modality treatment can be delivered successfully setting. Efficacy results consistent with previous results.