The safety profile of Tumor Treating Fields (TTFields) therapy in glioblastoma patients with ventriculoperitoneal shunts

Abstract

Introduction Tumor Treating Fields (TTFields, 200 kHz) therapy is a noninvasive, locoregional cancer treatment approved for use in newly diagnosed glioblastoma (GBM), recurrent GBM, and malignant pleural mesothelioma. GBM patients with hydrocephalus may require implantation of a ventriculoperitoneal (VP) shunt, however, the current TTFields therapy label does not include the use of VP shunts in GBM patients due to insufficient safety data. This analysis evaluates the safety of TTFields therapy use in this population. Methods Unsolicited post-marketing global surveillance data from patients with GBM and a VP shunt (programmable/non-programmable) who received TTFields therapy between November 2012–April 2021 were retrospectively analyzed. Adverse events (AEs) were assessed using the Medical Dictionary for Regulatory Activities version 24.0. Results Overall, 156 patients with VP shunts were identified and included in this analysis. In total, 77% reported ≥ 1 AE; the most common TTFields therapy-related AEs were non-serious and localized, beneath-array skin AEs (43%). The incidence and categories of AEs were comparable between patients with or without VP shunts. Six patients with VP shunts experienced seven serious TTFields therapy-related AEs: skin erosion at the shunt site (n = 3); wound dehiscence at the shunt site (n = 2) and at the resection scar (n = 2). No shunt malfunctions were deemed related to TTFields therapy. Conclusions In the real-world setting, TTFields therapy in GBM patients with VP shunts demonstrated good tolerability and a favorable safety profile. There was no evidence that TTFields therapy disrupted VP shunt effectiveness. These results suggest TTFields therapy may be safely used in patients with VP shunts.

Tumor Treating Fields (TTFields) Therapy Concomitant with Taxanes for Cancer Treatment

“…The optimal TTFields frequency for NSCLC cells and pancreatic cancer cells is 150 kHz, and 200 kHz for ovarian cancer cells [28][29][30]. As TTFields selectively target the distinct properties of cancer cells such as division rate and morphology, healthy cells are largely unaffected [31][32][33].…”

Efficacy of tumour-treating fields therapy in recurrent glioblastoma: A narrative review of current evidence

“…A post-marketing surveillance study ventured to investigate TTFields therapy's safety in GBM patients with VP shunts, revealing predominantly minor and localized adverse events primarily linked to skin-related concerns. [78] The potential of TTFields therapy extends to pediatric patients with malignant brain tumors, particularly high-grade gliomas, which present formidable treatment challenges. In light of the limitations of conventional therapies for pediatric Central Nervous System malignancies, TTFields therapy emerges as a noninvasive avenue warranting exploration.…”

“…As a noninvasive, locoregional therapeutic approach, TTFields therapy has secured approval for application in Glioblastoma (GBM) and malignant pleural mesothelioma. [ 78 ] However, due to limited safety data, the current therapeutic label for TTFields does not encompass its use in GBM patients with ventriculoperitoneal (VP) shunts. A post-marketing surveillance study ventured to investigate TTFields therapy’s safety in GBM patients with VP shunts, revealing predominantly minor and localized adverse events primarily linked to skin-related concerns.…”

“…A post-marketing surveillance study ventured to investigate TTFields therapy’s safety in GBM patients with VP shunts, revealing predominantly minor and localized adverse events primarily linked to skin-related concerns. [ 78 ]…”

Tumor-Treating Fields in Glioblastomas: Past, Present, and Future

“…TTFields-associated skin reactions include allergic or irritant dermatitis; xerosis or pruritus; mechanical lesions; hyperhidrosis; and, more rarely, skin erosion, infections, and ulcers [ 113 , 114 , 115 ]. The causes of dermatologic AEs are diverse, including a moist occluded scalp environment, chronic use of steroidal medicine and systemic anticancer drugs, and irritation of the skin at the site of the previous surgical wound by the liquid medium of the electrode array [ 116 , 117 , 118 , 119 , 120 , 121 ].…”