Feasibility of Tumor Treating Fields with Pemetrexed and Platinum-Based Chemotherapy for Unresectable Malignant Pleural Mesothelioma: Single-Center, Real-World Data

SIMPLE SUMMARY: Management of malignant pleural mesothelioma (MPM) is challenging as patients frequently present with unresectable disease and the response rates with systemic therapy alone remain low. Given the paucity of effective therapies for MPM, Tumor Treating Fields (TTFields) therapy was made available for use under an FDA-approved Humanitarian Device Exemption (HDE) protocol in 2019, but no real-world data beyond the initial trial have been published to date. We reviewed our retrospective series of five patients diagnosed with MPM and treated with TTFields with pemetrexed and platinum-based chemotherapy. This therapy resulted in a modest disease-stabilization rate with no significant device-related major toxicities. However, we observed universal low-grade skin toxicities related to the device which required medical management and self-discontinuation in 2/5 patients. We also observed lower device usage, compared to the STELLAR trial. Both of these represent opportunities for developing improved management guidelines and efforts to improve patient compliance. ABSTRACT: Purpose: The objectives of this study were to evaluate the implementation, device usage rates, clinical outcomes, and treatment-related toxicities associated with TTFields and pemetrexed plus platinum-based chemotherapy in patients with unresectable MPM, outside the initial trial results. Methods: Consecutive patients with unresectable MPM were enrolled onto an FDA-required HDE protocol from 2019 to 2021. All patients were treated with a protocol-defined regimen of continuous TTFields (150 kHz) and pemetrexed plus platinum-based chemotherapy. Results: Five patients with unresectable MPM were enrolled. The median number of 4-week TTFields cycles was 5 (range: 2–7 cycles). Median TTFields device usage in the first 3 months was 12.5 h per day (range: 5–16.8 h), representing 52% (21–70%) of the potential daily duration. The median follow-up was 5.4 months (range: 1.1–20.9 months). Treatment-related dermatitis was the only side effect associated with TTFields and was reported as grade 1–2 in all patients; no patient had grade 3+ device-related toxicities. Conclusions: This study represents the first results of real-world implementation of TTFields for MPM. In comparison to the initial clinical trial (STELLAR), compliance rates were lower, although skin-related toxicities appeared similar. Further initiatives and guidelines should be developed to manage treatment-related dermatitis and improve device usage.