A 44 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2021.During a neuro-oncology visit on (b)(6) 2022, the prescribing physician noted the patient developed a 1 cm scalp erosion near the surgical resection incision (last surgical resection on (b)(6) 2020).The patient remained on optune therapy.On (b)(6) 2022, the patient presented to neuro-oncology clinic visit, to discuss if surgical treatment for an open scalp wound is required, no further details were available at that time.Patient remained on optune therapy.On (b)(6) 2023, it was reported that due to a wound complication, the patient was scheduled for surgery on (b)(6) 2023.Optune therapy was temporarily discontinued.Per the healthcare provider the patient was planned to undergo repair of a chronic non-healing right frontal scalp wound.On (b)(6) 2023, the spouse reported a small portion of cranial bone was surgically removed on the right side of the head and the patient was still recovering.Optune therapy would be resumed once cleared by neurosurgery.No causality assessment was provided by the prescribing physician.
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Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.Wound dehiscence was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only.
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