CivaSheet® use for soft tissue sarcoma: A single institution experience.

Area of Science:

• Oncology
• Radiation Oncology
• Medical Devices

Background:

• Soft tissue sarcoma (STS) presents treatment challenges, especially in patients who have reached maximum radiation tolerance.
• Intraoperative radiation therapy (IORT) offers a method to deliver targeted radiation doses during surgery.
• Palladium-103 (Pd-103) is a radioisotope used in brachytherapy for its dosimetric properties.

Purpose of the Study:

• To evaluate the initial clinical experience and outcomes of using CivaSheet, an implantable intraoperative radiation therapy device utilizing palladium-103.
• To assess the safety and efficacy of CivaSheet in patients with surgically resected soft tissue sarcomas.
• To determine the local recurrence rates and complication profiles associated with CivaSheet placement.

Main Methods:

• A retrospective chart review was conducted for patients with STS treated with surgical resection and CivaSheet placement between January 2018 and December 2019.
• The CivaSheet device, containing palladium-103, delivered an average adjuvant radiation dose of 47 Gy to a depth of 5 mm.
• Patient data included tumor location, size, surgical reconstruction methods, local recurrence, and complications.

Main Results:

• Ten CivaSheets were implanted in nine patients with STS, with a mean follow-up of 27 months.
• Tumor locations varied, including retroperitoneum, chest, groin, and lower extremity, with an average tumor size of 7.6 cm.
• A local recurrence rate of 40% was observed. Grade 4 complications occurred in three patients, necessitating device removal, particularly in cases with prior radiation and flap reconstruction. Extremity tumors showed a high rate of Grade 4 adverse events.

Conclusions:

• CivaSheet represents a novel approach for intraoperative radiation boost in STS patients.
• While demonstrating potential, the observed local recurrence and complication rates warrant further investigation.
• CivaSheet may be a viable alternative to traditional brachytherapy methods, but careful patient selection and monitoring are crucial.