Patients with nonmetastatic soft-tissue sarcoma who need preoperative radiation therapy can safely receive hypofractionated treatment for 3 weeks instead of 5 weeks, with comparable tumor control and no increased risk of major complications in wound healing, according to a new study published by Guadagnolo et al in The Lancet Oncology.
In the single-arm, nonrandomized trial—the results of which were also presented at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 245)—patients received hypofractionated radiation therapy consisting of higher daily radiation therapy doses per treatment over 3 weeks. About 31% of patients developed major wound complications within 120 days of surgery, while local tumor control was 93% at the 2-year follow-up—statistics that were comparable to historically reported rates of the conventional 5-week treatment course.
The trial enrolled 120 patients aged 18 years and older with nonmetastatic soft-tissue sarcoma in the extremity or superficial trunk who had not previously undergone radiation therapy. Of the participants involved in the trial, 65% of them had lower-extremity tumors, 17% had upper-extremity tumors, and 18% had tumors in the trunk.
All of the patients were treated with a 3-week course of radiation consisting of 15 daily fractions of 2.85 Gy, totaling 42.75 Gy; the current standard dose is 50 Gy in 25 daily fractions, or a 5-week course. Radiation therapy was followed by surgery 4 to 8 weeks later. Researchers assessed major wound complications within 120 days of surgery.
Study Implications
“Our data indicate the 3-week regimen offers patients a likely safe and effective alternative to the current standard of care with comparable outcomes in disease control and no increased risks of major wound complications,” said first study author B. Ashleigh Guadagnolo, MD, MPH, Professor of Radiation Oncology at The University of Texas MD Anderson Cancer Center. “We are excited by the current results of this study, which demonstrate the value of a hypofractionated approach to radiation therapy, which is more convenient for patients.”
A major side effect of preoperative radiation therapy in patients with nonmetastatic soft-tissue sarcoma is an increased risk of wound-healing complications after surgery. These patients have a higher chance of needing a second operation for wound repair, extensive wound management, and readmission to the hospital.
Researchers found that no patients experienced serious adverse events or grade 3 acute skin toxicities while on the study. The 31% rate of major wound complications was comparable to the historically observed 35% rate in patients treated with the standard 5-week regimen.
“Research shows that patients receiving their treatment at cancer centers with sarcoma specialists have better survival and functional outcomes. Being able to shorten our patients’ treatment time from 5 to 3 weeks may improve care accessibility because patients would be able to reduce their time away from home if they do not live near a sarcoma specialty center,” Dr. Guadagnolo said.
The long-term side effects, as well as the oncologic and functional outcomes of using the hypofractionated regimen, are still being assessed.
Disclosure: The research in this study was supported by the National Cancer Institute. For full disclosures of the study authors, visit thelancet.com.
