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Tumour Treating Fields Therapy Shows ‘Promising’ OS For Unresectable Mesothelioma

Use of tumour treating fields alongside pemetrexed–platinum chemotherapy shows potential as a first-line regimen for malignant pleural mesothelioma patients who are unable to undergo surgery
18 Oct 2019
Anticancer Agents;  Clinical Research;  Mesothelioma
By Lynda Williams, Senior medwireNews Reporter

medwireNews: Use of tumour treating fields (TTFields) therapy alongside first-line chemotherapy might improve overall survival (OS) without increasing toxicity for patients with unresectable malignant pleural mesothelioma, say the STELLAR study investigators.

“TTFields are an innovative treatment modality which has so far been unexplored in patients with malignant pleural mesothelioma”, explain Giovanni Ceresoli, from Cliniche Humanitas Gavazzeni in Bergamo, Italy, and co-workers.

“Although our results require further confirmation in a larger randomised trial, STELLAR data support the use of TTFields in combination with chemotherapy in patients with newly diagnosed unresectable malignant pleural mesothelioma”, they write in The Lancet Oncology.

The phase II trial assessed the application of low-intensity TTFields at 150 Hz to the thorax for up to 18 h/day concomitantly with six 21-day cycles of chemotherapy consisting of pemetrexed 500 mg/m2 and an investigators’ choice of cisplatin 75 mg/m2 or carboplatin to an area under the curve of 5 given on day 1. Patients who did not progress during chemotherapy continued with maintenance TTFields until disease progression or toxicity.

After a median of 12.5 months of follow-up, median OS was 18.2 months and median progression-free survival (PFS) was 7.6 months.

The team describes the survival results as “promising” for a cohort where a third of patients had non-epithelioid histology associated with a particularly poor prognosis and 63% were given carboplatin, which is “a regimen mostly used in patients who might not be able to tolerate cisplatin, including older patients.”

And in post-hoc analysis, median OS was 21.2 months for the 66% of patients with epithelioid histology versus 12.1 months for those with sarcomatoid or biphasic histology, or unknown tumour types, with corresponding PFS durations of 8.3 and 6.5 months.

Overall, 40% of the patients had a RECIST partial response lasting a median of 5.7 months and 57% had stable disease, with 56% of patients going onto a subsequent treatment after progression.

“Notably, the activity reported in the STELLAR trial was achieved without an increase in systemic toxicity”, the researchers say, with the only TTFields-related adverse events reported being skin irritation at the medical device site.

All but 5% of these reactions were grade 1–2 and were mainly managed by topical steroids, movement of the array site, and short treatment breaks, they comment.

“The signal for activity achieved with the addition of TTFields to standard chemotherapy is further validated by comparison with two recent randomised trials in malignant pleural mesothelioma, the MAPS and the LUME-Meso trials”, Giovanni Ceresoli et al believe.

Despite both these studies having patients with better ECOG performance status, and a greater proportion of tumours with epithelioid histology, than found in the STELLAR participants, MAPS achieved a comparable median OS of 18.1 months with the addition of bevacizumab to chemotherapy, while a median OS of 18.3 months was achieved for the phase II arm of the LUME-Meso trial of nintedanib plus chemotherapy.

And the authors note that the phase III findings for LUME-Meso failed to demonstrate a significant improvement with nintedanib versus chemotherapy alone for the epitheliolid histology subgroup, with a median OS of 14.4 months, which is lower than that achieved within the STELLAR subgroup.

Discussing the results further in an accompanying comment, Dean Fennell, from Leicester Cancer Research Centre in the UK, observes that STELLAR met its primary endpoint of a 5-month advantage over the expected OS for chemotherapy alone of 12.1 months and this has resulted in FDA approval of the treatment for mesothelioma.

“However, the question as to whether or not there truly exists a measurable and positive incremental benefit in overall survival conferred by TTFields over historical controls in 2019 remains unanswered”, he writes.

The commentator concludes: “[S]ystemic therapy remains the first-line therapy for mesothelioma, but STELLAR presents a promising signal of efficacy that urgently needs reinforcement via the gold-standard of randomised evaluation.” 

 

References  

Ceresoli GL, Aerts JG, Dziadziuszko R, et alTumour 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 trialLancet Oncol; Advance online publication 15 October 2019. https://doi.org/10.1016/S1470-2045(19)30532-7 

Fennell DA. Tumour treating fields for mesothelioma: controversy versus opportunityLancet Oncol; Advance online publication 15 October 2019. https://doi.org/10.1016/S1470-2045(19)30642-4

Last update: 18 Oct 2019

medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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