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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

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

From the Roswell Park Cancer Institute, Buffalo, NY; Beth Israel Cancer Center, New York, NY; Radiation Therapy Oncology Group, Philadelphia, PA; Massachusetts General Hospital; Francis H. Burr Proton Therapy Center, Boston, MA; Johns Hopkins Medical Center, Baltimore, MD; University of Michigan Medical Center, Ann Arbor, MI; H. Lee Moffitt Cancer Center, Tampa, FL; Dartmouth Hitchcock Medical Center, Lebanon, NH

Address reprint requests to William G. Kraybill, MD, Department of Surgical Oncology, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263; e-mail: william.kraybill{at}roswellpark.org

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 neoadjuvant 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]), interdigitated 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.

Deceased.

Supported by Grants No. U10 CA21661, U10 CA37422, and U10 CA32115 awarded by the National Cancer Institute.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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