A 72-year-old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2021.Novocure was informed on february 17, 2023, that the patient developed an open area with exposed cranial hardware at the surgical resection site (last surgical resection (b)(6) 2021).In available medical records, the prescribing physician noted on (b)(6) 2023, an open wound with exposed hardware developed in (b)(6) 2023, however the patient did not report to the physician and continued to place arrays over the affected area.Treatment included a ten day course of antibiotics (cephalexin 500mg qid).On (b)(6) 2023, the patient made novocure aware she had recurrent surgery scheduled for that week.On (b)(6) 2023, the healthcare provider reported, the patient experienced disease progression, had evidence of wound dehiscence and exposed cranial hardware without infection.The patient underwent a left craniotomy and removal of cranial hardware on (b)(6) 2023.Optune therapy was discontinued.Per the prescriber, optune therapy contributed to the event.
|
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 surgeries 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.
|