Tumor Treating Fields (TTFields) in GEneral Routine clinical care in patients with pleural mesothelioma (TIGER Meso)

Background: Pleural mesothelioma (PM) is a rare cancer that is commonly associated with asbestos exposure. Due to its diffuse and distinct dispersion in the pleura, an R0 resection is hard and the prognosis bad. Recently, checkpoint inhibitors showed an extension of overall survival (OS) in unresectable PM, but a high unmet medical need for effective treatment remains. Tumor Treating Fields (TTFields) are low-intensity, intermediate frequency alternating electric fields that inhibit cancer cell division. In a phase 2 study (STELLAR), adding TTFields to pemetrexed plus cisplatin or carboplatin yielded encouraging results regarding median OS and progression-free survival. There is interest among prescribing physicians to validate these results in routine clinical care. The aim of this study is to evaluate safety and efficacy of TTFields in routine clinical care of PM, as well as changes in quality of life (QoL), treatment duration and device usage.

Methods: The TIGER Meso study is a non-interventional, observational, prospective study to be conducted in Germany, Italy and the Netherlands (NCT05538806). Patients with PM without an option of curative resection who are eligible for TTFields therapy will be asked for consent for study participation. TTFields will be delivered non-invasively and locoregionally at a frequency of 150 kHz by placing transducer arrays connected to a portable medical device on the thorax. At baseline and months 3 and 6 after treatment start, demographic data and QoL (EQ-5D-5L, QLQ-LC13, and LCSS-Meso questionnaires) will be assessed. For the remaining endpoints, follow-up visits will be scheduled every 2-4 months in line with routine clinical care recommendations. The planned number of patients is about 200 with a follow-up period of 18 months.

Results: The TIGER Meso study is currently enrolling patients.

Conclusion: The TIGER Meso study will generate prospective data for the use of TTFields in routine clinical care of PM. The study supports the evaluation of treatment-related data, which could play a role in future assessment of treatment duration and usage.

Publication History

Article published online:
01 March 2024