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Information × Registration Number 0219U001572, 0116U002406 , R & D reports Title To determine the optimal algorithm of complex treatment of patients with high risk soft tissue sarcoma. popup.stage_title Head Korovin Sergey I., Доктор медичних наук Registration Date 07-02-2019 Organization Ukrainian Research Institute of Oncology and Radiology popup.description2 The study object are 81 patients with high risk soft tissue sarcomas (STS) of extremities and trunk. The purpose of study is to improve the results of treatment of patients with high risk STS by developing an optimal integrated treatment algorithm. Research methods and equipment - clinical, morphological, statistical. The algorithm of complex treatment of high risk STS patients includes surgical intervention, radiation therapy (RT) and polychemotherapy (PCT). Based on algorithm 81 subjects with high risk STS were treated in both groups of the study. Prior to treatment patients with clinical signs of STS located in limbs and trunk without clinical signs of regional lymph node involvement were examined including tumor biopsy with histological examination, computer tomography of the chest and abdominal cavity, magnetic resonance imaging of the lesions. After examination, patients were randomized into two groups. In group 1 (40 patients) treatment was started with neoadjuvant (NA) PCT according to the protocol CYVADIC - 2 courses with 3-week interval. Surgical intervention was carried out 4 weeks after the end of the last course of PCT. In the adjuvant setting RT on the removed tumor bed was performed in the total dose (TD) 50 - 55 Gy with a single dose (SD) of 1.8-2.0 Gy and 2 courses of PCT under VAC scheme. Patients in group 2 (41 patients) received NA treatment: 2 courses of systemic PCT by protocol CYVADIC and RT on the tumor site TD 40 Gy for SD 1, 8-2.0 Gy. The surgical excision was performed 4 weeks after the end of irradiation. Adjuvant course of RT on the removed tumor bed (TD 15 Gy with SD 1.8-2.0 Gy) and 2 courses of PCT under the VAC scheme were performed after wound healing. In the study it has been proved that combined NA therapy (RT + PCT) has a significant advantage (14.5%; p = 0.04) compared with PCT according to RECIST 1.1 criteria. It has been established that NA combination therapy (RT + PCT) has a significant advantage (35.3%; p = 0.01) compared with PCT by the system for assessing the relative proportion of viable tumor tissue. The use of preoperative PCT leads to less postoperative complications (20% vs. 36.6%) compared to combined NA therapy (RT + PCT). However, this indicator is not statistically significant (16.6%; p = 0.09). It was established that 3-year overall survival (1 group (75.0 ± 6.8)% and group 2 (70.7 ± 7.7)%), 3-year free from disease survival (group 1 (67.5 ± 7.4)%, group 2 (56.1 ± 7.8)%) and 3-year recurrent-free survival (local control) (group 1 (87.2 ± 5.2)% and Group 2 (89,5 ± 4,6)%) did not differ significantly in both groups. A definite advantage (16.4%, p = 0.04) of the 3-year metastases-free survival rate of patients in group 1 with respect to patients in group 2 was determined. Indicators of long-term 3-year results (overall, metastases-free and recurrent-free survival) of complex treatment for patients with ІІb-ІІІ stage STS do not correlate with direct results of preoperative therapy (RECIST1.1 and system for estimating the relative fraction of viable tumor tissue). SARCOMA OF SOFT TISSUES, SURGICAL TREATMENT, RADIATION THERAPY, CHEMOTHERAPY, NEOADJUVANT AND ADJUVANT THERAPY Product Description popup.authors Кукушкіна Марія Миколаївна Остафійчук Василь Васильович Палій Максим Игорович popup.nrat_date 2020-04-02 Close