On August 30, 2021 CivaTech Oncology reported that Physicians from four medical centers recently published data this month from an initial six patients implanted with CivaSheet to treat retroperitoneal sarcoma (Press release, CivaTech Oncology, AUG 30, 2021, View Source [SID1234587011]). The article, titled "Initial Clinical Experience With Novel Directional Low-dose Rate Brachytherapy for Retroperitoneal Sarcoma" was accepted for publication in the Journal of Surgical Research on June 28, 2021. With a mean follow up of 16 months, no local cancer recurrences, no toxicities, and no complications have been reported.
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Approximately 13,460 new soft tissue sarcomas will be diagnosed and 5,350 people are expected to die of soft tissue sarcomas in 2021. (American Cancer Society). And Retroperitoneal Sarcomas (RPS) make up approximately 15% of all patients with soft tissue sarcoma. Despite advances in cancer care, however, many of these patients endure multiple recurrences and their overall 5 year survival rate remains under 65%.
CivaSheet, a new bio-absorbable, internal radiation treatment, is implanted in approximately 30 minutes in the operating room at the time of sarcoma surgery. CivaSheet is designed to help prevent sarcoma recurrence by delivering a highly targeted dose of radiation directly to the surgical margin where residual cancer cells may remain. CivaSheet’s integrated shielding protects healthy surrounding organs, enabling a higher dose than can be administered using other treatment options.
"CivaSheet has been effective for our patients as it allows the clinician to personalize therapy to the patient’s anatomy at the time of surgery and to their previous course of treatment to minimize long term radiation side-effects," said Krisha Howell MD, Clinical Director of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.
Designed and manufactured by CivaTech Oncology, CivaSheet is a flexible, implantable intra-operative radiation therapy device (brachytherapy), which emits unidirectional radiation using integrated gold shielding. The unidirectional property makes the device active on one side to provide a homogenous radiation dose. This feature is entirely unique to CivaSheet, allowing physicians to safely deliver aggressive radiation doses immediately adjacent to healthy, sensitive tissue. No complications or radiation related side effects have been reported in nearly 150 patients treated with CivaSheet to date. Radiation is delivered over the course of several weeks as the isotope naturally decays, eliminating the need for repeat hospital visits, and no follow up procedure is necessary to remove the device.
CivaSheet has broad FDA clearance to include soft tissue sarcomas and many other malignancies. This sarcoma Registry will help to determine CivaSheet’s impact on local control and recurrence.