1627P - Single arm prospective study evaluating the role of neoadjuvant chemotherapy in soft tissue sarcoma

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Background: Surgery is the primary standard of care for localized soft tissue sarcoma (STS). In certain cases, upfront surgery may not be possible, or it may be mutilating and disfiguring. We conducted this study to evaluate the role of neoadjuvant chemotherapy in this setting. Methods: This single arm prospective study included patients of age ≥18 years with chemotherapy naïve STS of size ≥ 5 cm and which were grade II/III. These tumors were either upfront unresectable or possibly resectable with undesirable outcomes. Ewings sarcoma, osteosarcoma, rhabdomyosarcoma and other chemoresistant STS were excluded. The patients received three cycles of Ifosfamide (1.8 gm/m2 d1-d5) and epirubicin (60 mg/m2 d1-d2) followed by clinical and radiologic reassessment. The primary objective was overall response rate (ORR), and the secondary objective was to assess conversion to limb salvage surgery (LSS). Overall response was defined as complete response (CR) plus partial response (PR). Results: We included 36 patients in this study with a mean age of 36.9±14.7 years. The ratio male: female was 1.1. The most common histology in our cohort was synovial sarcoma [16 (44.4%)] followed by MPNST [5 (13.8%)]. Extremity [ 23 (63.8%)] was the most common site followed by trunk [8 (22.2%)] and head and neck [5 (13.8%)]. PR was seen in 14 (38.8%) patients, 16 (44.4%) patients had stable disease, three patients had progression and none of the patients had CR. The response could not be assessed in three patients. The ORR was 44.4%. LSS could be done for 13 (56.5%) patients with extremity STS. Ten patients with extremity STS required amputation despite neoadjuvant chemotherapy of which 6 (60%) patients did not give consent for amputation. The chemotherapy regimen was well tolerated, febrile neutropenia was seen in 12.5%. There was no treatment-related mortality. Conclusions: Neoadjuvant chemotherapy is an effective and safe option for unresectable STS or those who are resectable but require mutilating or disfiguring surgery. The acceptance of amputation as a mean of treatment of STS is low in our population. Clinical trial identification: CTRI/2017/07/008997. Legal entity responsible for the study: AIIMS. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.