Spałek Mateusz Jacek, Borkowska Aneta Maria, Telejko Maria, Wągrodzki Michał, Niebyłowska Daria, Uzar Aldona, Białobrzeska Magdalena, Rutkowski Piotr
Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, 02-781 Warsaw, Poland.
Department of Radiotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, 02-781 Warsaw, Poland.
Cancers (Basel). 2021 Mar 16;13(6):1332. doi: 10.3390/cancers13061332.
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.
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.
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.
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.
对于因化疗耐药病理或禁忌证而不适合新辅助化疗的患者,边缘可切除或不可切除的软组织肉瘤(STS)的管理仍然是一项挑战。因此,在这些适应症中,我们旨在研究10次3.25 Gy放疗联合区域热疗(HT)后行手术或4次4 Gy放疗联合HT的可行性。
我们招募了局部晚期边缘可切除或不可切除的STS患者,这些患者(1)表现为化疗耐药的STS亚型,或(2)新辅助化疗后病情进展,或(3)不适合化疗。主要终点是所提议方案的可行性。
30名患者入组。所有患者均接受了治疗的第一部分,即放疗联合HT。其中,14名患者接受了放疗联合HT的第二部分治疗,而13名患者接受了手术。3名患者未完成治疗方案。90%的患者符合可行性标准。2名患者发生远处转移。1名患者因远处进展死亡。1名患者术后出现快速局部复发。
对于不适合化疗的边缘可切除或不可切除的STS患者,低分割放疗联合HT是一种可行的治疗方法。该临床试验结果支持进一步验证放疗与HT联合在STS中的应用。