The Feasibility Study of Hypofractionated Radiotherapy with Regional Hyperthermia in Soft Tissue Sarcomas

SIMPLE SUMMARY: The recommended management of marginally resectable or unresectable soft tissue sarcomas is an attempt of neoadjuvant therapy. The use of neoadjuvant chemotherapy is limited in low-grade tumors, sarcomas with chemoresistant pathology or in unfit patients. There is a growing evidence on hypofractionated radiotherapy in soft tissue sarcomas, but its efficacy may be limited by radioresistance that is frequently associated with chemoresistance. Regional hyperthermia is a potent and minimally invasive radiosensitizer. We aimed to investigate the feasibility of moderately hypofractionated radiotherapy combined with regional hyperthermia in aforementioned clinical situations. Our findings indicate that proposed combination is feasible while maintaining good short-term local efficacy and tolerance. It could serve as a basis for further studies on radiotherapy with hyperthermia in soft tissue sarcomas. ABSTRACT: Introduction: Management of marginally resectable or unresectable soft tissue sarcomas (STS) in patients who are not candidates for neoadjuvant chemotherapy due to chemoresistant pathology or contraindications remains a challenge. Therefore, in these indications, we aimed to investigate a feasibility of 10x 3.25 Gy radiotherapy combined with regional hyperthermia (HT) that could be followed by surgery or 4x 4 Gy radiotherapy with HT. Materials and methods: We recruited patients with locally advanced marginally resectable or unresectable STS who (1) presented chemoresistant STS subtype, or (2) progressed after neoadjuvant chemotherapy, or (3) were unfit for chemotherapy. The primary endpoint was the feasibility of the proposed regimen. Results: Thirty patients were enrolled. All patients received the first part of the treatment, namely radiotherapy with HT. Among them, 14 received the second part of radiotherapy with HT whereas 13 patients underwent surgery. Three patients did not complete the treatment protocol. The feasibility criteria were fulfilled in 90% of patients. Two patients developed distant metastases. One patient died due to distant progression. One patient developed rapid local recurrence after surgery. Conclusions: Hypofractionated radiotherapy with HT is a feasible treatment for marginally resectable or unresectable STS in patients who are not candidates for chemotherapy. Results of this clinical trial support the further validation of RT and HT combinations in STS.