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Clinical Trial
. 2025 Jan 1;131(1):e35542.
doi: 10.1002/cncr.35542. Epub 2024 Aug 27.

Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS): Updated local control, late toxicities, and patient-reported outcomes

Andrew J Bishop  1 , Devarati Mitra  1 , Ahsan Farooqi  1 , David M Swanson  2 , Caroline Hempel  1 , Tiara Willis  1 , Chris Pearlnath  1 , Wei-Lien Wang  3 , Ravin Ratan  4 , Neeta Somaiah  4 , Robert S Benjamin  4 , Keila E Torres  5 , Kelly K Hunt  5 , Christopher P Scally  5 , Emily Z Keung  5 , Robert L Satcher  6 , Justin E Bird  6 , Patrick P Lin  6 , Bryan S Moon  6 , Valerae O Lewis  6 , Christina L Roland  5 , B Ashleigh Guadagnolo  1   7
Affiliations
Clinical Trial

Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS): Updated local control, late toxicities, and patient-reported outcomes

Andrew J Bishop et al. Cancer. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: hypofractionated; hypofractionation; preoperative; radiation; radiation therapy; sarcoma; soft tissue.

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Conflict of interest statement

Disclaimers: The authors declare no conflicts of interest.

References

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