Physicians report CivaSheet®, a unidirectional LDR brachytherapy implant made by CivaTech Oncology, demonstrates up to three-year local control in recurrent retroperitoneal sarcomas when implanted during surgical resection. The crude cumulative incidence of local recurrence (LR) is 26%. To date, 21 sarcoma patients have been implanted with CivaSheet at six medical centers. Sarcoma patients tolerate the implant well with no complications following surgery. None of the 21 patients (0/21) have demonstrated local recurrence. There were no reported incidences of acute or late radiation toxicity despite the surrounding organs at risk, including small bowel, ureter and kidneys. The directional source distribution allows for safe re-irradiation or adjuvant brachytherapy boost radiation therapy in patients who have had maximum EBRT dose.
A recent publication details a patient with more than 3 years follow up. This report demonstrates “CivaSheet was associated with durable local control and significant reduction in doses to OARs including bowel, rectum, and bladder.” Additionally, “the bioabsorbability, flexibility, and easy identification on CT imaging allow this device to treat tumors in irregularly shaped cavities such as the pelvic sidewall and retroperitoneum.” The uni-directional design protects healthy tissues allowing a targeted dose with no toxicity. The novel polymer encapsulation allows unprecedented dose uniformity. “Moreover, the directional nature of this device helps increase the therapeutic ratio by avoiding unnecessary irradiation of OARs.” Furthermore, “CivaSheet expands IORT capabilities in a resource independent manner.” Application of uni-directional, planar Pd-103 LDR brachytherapy technology is safe and easy and should be considered as a standard option to escalate the dose to high-risk margins after resection.