Safia K Ahmed, Meng Xu-Welliver, Madeline Dorr, Kimberly O Steinert, Matthew T Houdek, Peter S Rose, S Mohammed Karim, Jonathan B Ashman, Krista A Goulding, Brittany L Siontis, Michael G Haddock, Ivy A Petersen
{"title":"下肢和浅干软组织肉瘤的术前低分割放疗：一项前瞻性II期试验的结果。","authors":"Safia K Ahmed, Meng Xu-Welliver, Madeline Dorr, Kimberly O Steinert, Matthew T Houdek, Peter S Rose, S Mohammed Karim, Jonathan B Ashman, Krista A Goulding, Brittany L Siontis, Michael G Haddock, Ivy A Petersen","doi":"10.1016/j.ijrobp.2025.05.006","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Preoperative radiation therapy (RT) for resectable extremity soft tissue sarcomas (STS) has historically been delivered over 5 weeks and associated with a 35% major wound complication (WC) rate. We investigated the rate of WC in a cohort of STS patients treated with a moderately hypofractionated course of preoperative RT.</p><p><strong>Patients and methods: </strong>MC1973 was a single-arm, prospective, phase 2, non-inferiority trial completed at Mayo Clinic in Minnesota and Arizona. We administered preoperative RT to 42.75 Gy in 15 fractions. Patients underwent standard of care tumor resection afterwards. The primary endpoint was a major WC occurring within 120 days of surgery. Wilcoxon Rank Sum tests, Fisher Exact tests, and Conchran-Armitage Trend tests were used to evaluate associations with WC. Kaplan-Meier analysis was used to report early survival-associated outcomes.</p><p><strong>Results: </strong>Between November 24, 2020 and January 30, 2024, 120 patients enrolled on trial. One patient withdrew prior to receiving treatment. Most common tumor location was proximal lower extremity (48.7%). After RT, 117 patients (97.5%) underwent tumor resection. Two patients treated with RT came off study prior to surgery due to death. A major WC developed in 27/117 patients (23.1%). Median time to WC resolution was 17.4 weeks. The rate of persistent WC at 6 months was 26%. On univariate analysis, leiomyosarcoma histology (n=5) correlated with a higher WC rate (60%). Median follow up was 21.1 months. Fourteen patients experienced acute grade 3 adverse events. One-year disease-free survival was 86.0% (95% CI, 79.7-92.9%). Two patients developed local recurrence. One fracture was observed.</p><p><strong>Conclusions: </strong>The major WC rate was 23.1% with a preoperative regimen of 42.75 Gy in 15 fractions. This suggests moderate hypofractionation is not inferior compared to historical standards of major WC rate. Additional follow-up will allow evaluation of oncologic outcomes, long-term treatment-associated adverse events, and patient reported outcomes.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4000,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Hypofractionated Preoperative Radiation Therapy for Extremity and Superficial Trunk Soft Tissue Sarcomas: Results of a Prospective, Phase II Trial.\",\"authors\":\"Safia K Ahmed, Meng Xu-Welliver, Madeline Dorr, Kimberly O Steinert, Matthew T Houdek, Peter S Rose, S Mohammed Karim, Jonathan B Ashman, Krista A Goulding, Brittany L Siontis, Michael G Haddock, Ivy A Petersen\",\"doi\":\"10.1016/j.ijrobp.2025.05.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Preoperative radiation therapy (RT) for resectable extremity soft tissue sarcomas (STS) has historically been delivered over 5 weeks and associated with a 35% major wound complication (WC) rate. We investigated the rate of WC in a cohort of STS patients treated with a moderately hypofractionated course of preoperative RT.</p><p><strong>Patients and methods: </strong>MC1973 was a single-arm, prospective, phase 2, non-inferiority trial completed at Mayo Clinic in Minnesota and Arizona. We administered preoperative RT to 42.75 Gy in 15 fractions. Patients underwent standard of care tumor resection afterwards. The primary endpoint was a major WC occurring within 120 days of surgery. Wilcoxon Rank Sum tests, Fisher Exact tests, and Conchran-Armitage Trend tests were used to evaluate associations with WC. Kaplan-Meier analysis was used to report early survival-associated outcomes.</p><p><strong>Results: </strong>Between November 24, 2020 and January 30, 2024, 120 patients enrolled on trial. One patient withdrew prior to receiving treatment. Most common tumor location was proximal lower extremity (48.7%). After RT, 117 patients (97.5%) underwent tumor resection. Two patients treated with RT came off study prior to surgery due to death. A major WC developed in 27/117 patients (23.1%). Median time to WC resolution was 17.4 weeks. The rate of persistent WC at 6 months was 26%. On univariate analysis, leiomyosarcoma histology (n=5) correlated with a higher WC rate (60%). Median follow up was 21.1 months. Fourteen patients experienced acute grade 3 adverse events. One-year disease-free survival was 86.0% (95% CI, 79.7-92.9%). Two patients developed local recurrence. One fracture was observed.</p><p><strong>Conclusions: </strong>The major WC rate was 23.1% with a preoperative regimen of 42.75 Gy in 15 fractions. This suggests moderate hypofractionation is not inferior compared to historical standards of major WC rate. Additional follow-up will allow evaluation of oncologic outcomes, long-term treatment-associated adverse events, and patient reported outcomes.</p>\",\"PeriodicalId\":14215,\"journal\":{\"name\":\"International Journal of Radiation Oncology Biology Physics\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.4000,\"publicationDate\":\"2025-05-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Radiation Oncology Biology Physics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ijrobp.2025.05.006\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Radiation Oncology Biology Physics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ijrobp.2025.05.006","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Hypofractionated Preoperative Radiation Therapy for Extremity and Superficial Trunk Soft Tissue Sarcomas: Results of a Prospective, Phase II Trial.
Background: Preoperative radiation therapy (RT) for resectable extremity soft tissue sarcomas (STS) has historically been delivered over 5 weeks and associated with a 35% major wound complication (WC) rate. We investigated the rate of WC in a cohort of STS patients treated with a moderately hypofractionated course of preoperative RT.
Patients and methods: MC1973 was a single-arm, prospective, phase 2, non-inferiority trial completed at Mayo Clinic in Minnesota and Arizona. We administered preoperative RT to 42.75 Gy in 15 fractions. Patients underwent standard of care tumor resection afterwards. The primary endpoint was a major WC occurring within 120 days of surgery. Wilcoxon Rank Sum tests, Fisher Exact tests, and Conchran-Armitage Trend tests were used to evaluate associations with WC. Kaplan-Meier analysis was used to report early survival-associated outcomes.
Results: Between November 24, 2020 and January 30, 2024, 120 patients enrolled on trial. One patient withdrew prior to receiving treatment. Most common tumor location was proximal lower extremity (48.7%). After RT, 117 patients (97.5%) underwent tumor resection. Two patients treated with RT came off study prior to surgery due to death. A major WC developed in 27/117 patients (23.1%). Median time to WC resolution was 17.4 weeks. The rate of persistent WC at 6 months was 26%. On univariate analysis, leiomyosarcoma histology (n=5) correlated with a higher WC rate (60%). Median follow up was 21.1 months. Fourteen patients experienced acute grade 3 adverse events. One-year disease-free survival was 86.0% (95% CI, 79.7-92.9%). Two patients developed local recurrence. One fracture was observed.
Conclusions: The major WC rate was 23.1% with a preoperative regimen of 42.75 Gy in 15 fractions. This suggests moderate hypofractionation is not inferior compared to historical standards of major WC rate. Additional follow-up will allow evaluation of oncologic outcomes, long-term treatment-associated adverse events, and patient reported outcomes.
期刊介绍：
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
