Tumour Treating Fields for mesothelioma - Authors' reply

Our plain-English summary of Tumour Treating Fields for mesothelioma - Authors' reply, by G.L. Ceresoli, L. Gianoncelli, F. Grosso, et al (The Lancet. Oncology, 2020).

The study

• Authors: G.L. Ceresoli, L. Gianoncelli, F. Grosso, STELLAR investigators
• Journal: The Lancet. Oncology
• Published: 2020;21(1):e10
• Type of article: Letter, Comment
• Cited by: 2 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

In plain English

This is a letter, not a new study. The authors of the STELLAR trial, a single-arm phase 2 trial of Tumour Treating Fields (TTFields) in malignant pleural mesothelioma, replied to two letters criticising it. The letter reports no new data and does not restate the trial's survival or response results. To the concern about selection bias, the authors acknowledged that any single-arm phase 2 study has well known limitations. They said patients' baseline characteristics were in line with other recent trials, that most patients were enrolled in large centres in regions with high occupational or environmental asbestos exposure, and that 26% had a non-epithelioid tumour, a recognised negative prognostic factor. They agreed that mitotic index is not a validated prognostic factor and said patients were not stratified for it. They disagreed that response or progression-free survival should have been the primary endpoint, citing a consensus report that overall survival should be the standard. The authors wrote that their conclusions were cautious and consistent with the study results. One author reported personal fees from several companies, including Novocure, outside the submitted work.

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: Correspondence (authors' reply to letters about the STELLAR single-arm phase 2 trial); no new data
• Who was studied: Patients with malignant pleural mesothelioma enrolled in the STELLAR trial, as described by the authors: most enrolled in large-volume centres in regions with high occupational or environmental asbestos exposure; 26% had a non-epithelioid tumour. The letter does not give the total number of patients.
• Exposure: Not an asbestos exposure study. The letter discusses Tumour Treating Fields (TTFields) as a treatment in malignant pleural mesothelioma. Asbestos is mentioned only as a feature of the regions where patients were enrolled.
• Main results:
  • The authors stated that patient baseline characteristics in STELLAR were in line with other recent malignant pleural mesothelioma trials (MAPS and LUME-Meso).
  • In STELLAR, 26% of patients had a non-epithelioid tumour, which the authors described as a recognised negative prognostic factor.
  • Patients in STELLAR were not stratified for mitotic index or other proliferation markers.
  • The authors disagreed that overall response or progression-free survival should have been the primary endpoint. They cited a consensus report that overall survival should be the standard endpoint in advanced malignant pleural mesothelioma.
• The authors' conclusion: The authors maintained that their conclusions from the STELLAR trial were cautious and strictly consistent with the study results.
• Limitations the authors state:
  • The authors acknowledged that single-arm phase 2 studies such as STELLAR have well known limitations.
  • The authors acknowledged the need for randomised studies to distribute potential confounders equally, as discussed in their original article.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Mesothelioma.

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)
• Tumour Treating Fields for mesothelioma: controversy versus opportunity — D.A. Fennell (2019)
• Tumour Treating Fields for mesothelioma — M. Barbarino, M. Bottaro, et al. (2020)
• Tumour Treating Fields for mesothelioma — C.J. de Gooijer, J.A. Burgers (2020)
• Tumour treating fields therapy for glioblastoma: current advances and future directions — O. Rominiyi, A. Vanderlinden, et al. (2021)
• Tumor Treating Fields (TTFields) downregulate the Fanconi Anemia-BRCA pathway and increase the efficacy of chemotherapy in malignant pleural mesothelioma preclinical models — H. Mumblat, A. Martinez-Conde, et al. (2021)

Browse more research in The Lancet. Oncology, or return to medical research.