e21503 Background: Neo-adjuvant therapy of soft tissue sarcoma is not standardized. Anthracyclines (A) improve disease free and overall survival in high grade extremity soft tissue sarcomas measuring more than 5 cm. A and ifosfamide (I) therapy require inpatient administration and is associated with significant toxicities when administered in combination with RT. G in combination with D has been shown to prolong progression free and overall survival in patients with advanced or metastatic STS after progression on A and I, and in patients unable to receive the combination. The safety of administration of G with radiation is not known. We evaluated the safety of neo-adjuvant G and D in combination with RT in patients with STS. Methods: Retrospective analysis of subjects with high grade STS treated with RT and neo-adjuvant chemotherapy with G and D was conducted. G 600mg/m2 was administered on days 1 and 8 along with D 75 mg/m2 on day 8 for a total of 3 cycles. 2200 cGY RT was administered in 11 daily fractions between cycles 1 and 2 and between cycles 2 and 3. 72 hour gap was given between RT and chemotherapy. Chemotherapy was administered on outpatient basis. Efficacy was evaluated by the extent of tumor necrosis at the time of surgery. Safety was evaluated by the presence of complications following chemotherapy. Results: GD + R was administered to 12 patients in the neo-adjuvant setting. 11 of them were evaluable for response. 10 of the 11 patients had evidence of tumor necrosis at the time of surgery. 1 patient had poor response. 3 of 11 patients had neutropenia complicating neo-adjuvant chemotherapy. 4 patients required hospital admission post chemotherapy. 3 for neutopenic fever, and 1 for fever, chills and pneumonia without neutropenia. Conclusions: Gemcitabine and taxotere combination with radiation therapy can be administered safely on outpatient basis with minimal toxicity. Further safety and efficacy evaluation of this therapy will need to be confirmed in a prospective phase II study. No significant financial relationships to disclose.
Neo-adjuvant chemotherapy for primary high-grade extremity soft tissue sarcoma
