对软组织肉瘤患者进行中度大分割术前放疗（HYPORT-STS；ClinicalTrials.gov 标识符 NCT03819985）对软组织肉瘤 (STS) 患者进行了放射生物学等效的中度大分割术前放疗 (RT) 15 × 2.85 Gy 疗程。在这里，作者报告了长期随访，以更新局部控制并报告晚期毒性，以及功能性和患者报告的结果。HYPORT-STS 是一项单中心、开放标签、单组、前瞻性 2 期临床该试验在 2018 年至 2021 年间招募了 120 名符合条件的四肢或浅表躯干 STS 成年患者。患者接受了为期 3 周的术前 RT，然后在 4-8 周后接受手术。终点和随访从手术之日起进行分析。中位随访时间为43个月（四分位距，37-52个月），4年局部无复发生存率为93%。总体而言，放疗相关的晚期毒性随着局部治疗时间的延长而改善 (p < .001)，并且很少有患者在 2 年时出现 ≥2 级毒性（9%；n = 8，共 88 名）。其中包括：2% ≥2 级皮肤毒性、2% 纤维化、3% 淋巴水肿和 1% 关节僵硬。四名患者 (3%) 发生骨折。根据肌肉骨骼肿瘤协会评定量表 (p < .001) 测量的功能结果和根据癌症治疗通用功能评估 (p < .001) 测量的生活质量，均随着治疗时间的推移而改善，并且与基线相比，这两项措施在 2 年随访时均优于基线。长期随访表明，对 STS 患者进行适度大分割术前放疗是安全有效的。较高级别的晚期毒性影响少数患者。晚期毒性随着时间的推移而减少，而功能结果和健康相关的生活质量似乎随着联合治疗时间的延长而改善。© 2024 美国癌症协会。

Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS; ClinicalTrials.gov identifier NCT03819985) investigated a radiobiologically equivalent, moderately hypofractionated course of preoperative radiotherapy (RT) 15 × 2.85 Gy in patients with soft tissue sarcoma (STS). Here, the authors report longer term follow-up to update local control and report late toxicities, as well as functional and patient-reported outcomes.HYPORT-STS was a single-center, open-label, single-arm, prospective phase 2 clinical trial that enrolled 120 eligible adult patients with localized STS of the extremities or superficial trunk between 2018 and 2021. Patients received a 3-week course of preoperative RT followed by surgery 4-8 weeks later. End points and follow-up were analyzed from the date of surgery.The median follow-up was 43 months (interquartile range, 37-52 months), and the 4-year local recurrence-free survival rate was 93%. Overall RT-related late toxicities improved with time from local therapy (p < .001), and few patients had grade ≥2 toxicities (9%; n = 8 of 88) at 2 years. These included: 2% grade ≥2 skin toxicity, 2% fibrosis, 3% lymphedema, and 1% joint stiffness. Four patients (3%) had bone fractures. Both functional outcomes, as measured by the Musculoskeletal Tumor Society Rating Scale (p < .001), and quality of life, as measured by the Functional Assessment of Cancer Therapy-General (p < .001), improved with time from treatment, and both measures were better in follow-up at 2 years compared with baseline.Long-term follow up suggests that moderately hypofractionated preoperative RT for patients with STS is safe and effective. Higher grade late toxicities affect a minority of patients. Late toxicities decrease over time, whereas functional outcomes and health-related quality of life seem to improve with more time from combined modality treatment.© 2024 American Cancer Society.