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

Our plain-English summary of Feasibility of Tumor Treating Fields with Pemetrexed and Platinum-Based Chemotherapy for Unresectable Malignant Pleural Mesothelioma: Single-Center, Real-World Data, by T. Kutuk, H. Appel, M.C. Avendano, et al (Cancers, 2022).

The study

• Authors: T. Kutuk, H. Appel, M.C. Avendano, F. Albrecht, P. Kaywin, S. Ramos, M.E. Suarez-Murias, M.P. Mehta, R. Kotecha
• Journal: Cancers
• Published: 2022;14(8)
• Cited by: 13 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

In plain English

This single-center study at the Miami Cancer Institute looked back at five patients with malignant pleural mesothelioma that could not be removed by surgery. From November 2019 to September 2021 they were treated under an FDA Humanitarian Device Exemption protocol with Tumor Treating Fields (TTFields), an electric-field device applied to the chest, together with pemetrexed and carboplatin chemotherapy. Patients were advised to use the device at least 18 hours a day. Four patients had epithelioid disease and one had sarcomatoid disease. Four had recurrent disease. In the first 3 months, median device use was 12.5 hours per day (52% of the day). Afterwards it fell to 8.9 hours per day (37%). All five developed skin irritation under the device: grade 1 in two patients and grade 2 in three. No patient had grade 3 or higher skin toxicity. Median follow-up was 5.4 months. At analysis, four patients were alive with stable disease, and one had died after disease progression. The authors concluded the combination was feasible for appropriately selected patients, but device use was lower than in the earlier STELLAR trial. They noted the small number of patients, the short follow-up and the retrospective design.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Retrospective single-center case series of patients treated on an FDA-required Humanitarian Device Exemption (HDE) protocol; descriptive statistics with Kaplan–Meier survival estimates
• Who was studied: Five patients with histologically confirmed unresectable, locally advanced or metastatic malignant pleural mesothelioma at the Miami Cancer Institute, enrolled November 2019 to September 2021. Median age 69 (range 64–84), three male. Four epithelioid and one sarcomatoid. Four had recurrent disease and one was newly diagnosed.
• Exposure: This was a treatment study, not a study of asbestos exposure. Patients received continuous TTFields at 150 kHz (NovoTTF-100L System), with recommended use of at least 18 hours per day, plus pemetrexed and platinum-based chemotherapy.
• Main results:
  • All five patients received carboplatin with pemetrexed. The median number of chemotherapy cycles during TTFields treatment was 5 (range 2–6).
  • Median device use in the first 3 months was 12.5 hours per day (range 5–16.8), which is 52% (21–70%) of the potential daily duration.
  • After 3 months, median device use fell to 8.9 hours per day (range 6.2–11.5), or 37% (26–48%) of the potential daily duration.
  • Two of 5 patients developed grade 1 dermatitis.
  • The other three patients developed grade 2 dermatitis.
  • No patient had device-related grade 3 or higher skin toxicity.
  • One patient (#2) stopped TTFields after the sixth cycle because of distant disease progression.
  • Two patients (#1 and #3) stopped TTFields by personal choice.
  • Median follow-up was 5.4 months (range 1.1–20.9) from the start of TTFields.
  • Four patients were alive at the time of analysis. Patient #2 died 13 months after completing TTFields treatment, due to disease progression.
  • Four of 5 patients continued to have stable disease, and 2 of 5 continued to use the device.
  • Progression-free survival was 80% at 6 months and 53% at 1 year.
  • Median overall and progression-free survival had not been reached.
• The authors' conclusion: The authors concluded that TTFields with pemetrexed and platinum-based chemotherapy is a feasible treatment strategy for appropriately selected patients. They found device use was lower than in the earlier STELLAR trial and lower than the suggested daily use. They called for further strategies to increase usage and to manage device-related skin effects.
• Limitations the authors state:
  • Because the study was retrospective, prior treatments were not standardized with respect to chemotherapy and radiotherapy regimen.
  • A limited number of patients with heterogeneous clinical stages were enrolled.
  • Short follow-up limited the evaluation of long-term side effects and survival estimates.
  • No patient-reported outcomes or quality-of-life measures were recorded.

Topics

Medical terms in this study, explained in our Lexicon: Tumor Treating Fields (TTFields), Pemetrexed (Alimta), Chemotherapy, Unresectable, Pleural Mesothelioma, Clinical Trial.

Related studies

• Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial — G.L. Ceresoli, J.G. Aerts, et al. (2019)
• Maintenance pemetrexed after platinum pemetrexed chemotherapy and survival outcomes in malignant pleural mesothelioma in a multicenter real world study — O. Aydin, Z.S. Isleyen, et al. (2026)
• Outcomes of Platinum plus /Pemetrexed Rechallenge in Pleural Mesothelioma: The Role of Platinum-Free Interval in a Multicenter Real-World Analysis — R. Shah, M. Reck, et al. (2026)
• Tumor Treating Fields (TTFields) Therapy in Unresectable Pleural Mesothelioma: Overview of Efficacy, Safety, and Future Outlook — G.L. Ceresoli, L. Gianoncelli (2025)
• Targeted Therapy Recommendations for Therapy Refractory Solid Tumors-Data from the Real-World Precision Medicine Platform MONDTI — H. Taghizadeh, M. Unseld, et al. (2020)
• The schemes, mechanisms and molecular pathway changes of Tumor Treating Fields (TTFields) alone or in combination with radiotherapy and chemotherapy — G. Tanzhu, L. Chen, et al. (2022)

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