16 juni 2025: Bron: The Lancet d.d. May 28, 2024

Uit de LUNAR fase 3 studie blijkt dat wanneer patienten met niet-kleincellige longkanker stadium 4 met falende chemotherapie naast een standaard behandeling ook een behandeling krijgen met het Tumor Treating Fields apparaatje Optune Dua de overall overleving statistisch significant langer blijkt in vergelijking met alleen een standaard behandeling. Totaal 276 patiënten gelijk verdeeld over de twee groepen namen deel aan deze gerandomiseerde studie. Mediane overleving na studieduur van 4 jaar bedroeg 13·2 maanden vs 9,9 maanden wat voor deze groep zwaar voorbehandelde patiënten echt een behoorlijke verbetering is.

Vertaling van het abstract:

Tussen 13 februari 2017 en 19 november 2021 werden 276 patiënten geïncludeerd en willekeurig toegewezen aan TTFields-therapie in combinatie met standaardtherapie (n=137) of alleen standaardtherapie (n=139).
De mediane leeftijd was 64 jaar (IQR 59-70), 178 (64%) waren mannen en 98 (36%) vrouwen,
156 patiënten (57%) hadden niet-plaveiselcelcarcinoom (niet-kleincellig longcarcinoom) en 87 patiënten (32%) hadden eerder een immuuncheckpointremmer gekregen.
De mediane follow-up was 10,6 maanden (IQR 6,1-33,7) voor patiënten die TTFields-therapie in combinatie met standaardtherapie kregen, en 9,5 maanden (0,1-32,1) voor patiënten die standaardtherapie kregen.
De algehele overleving was significant langer met TTFields-therapie en standaardtherapie dan met alleen standaardtherapie (mediaan 13,2 maanden [95% BI 10,3–15,5] versus 9,9 maanden [8,1–11,5]; hazard ratio 0,74 [95% BI 0,56–0,98]; p=0,035).
In de veiligheidspopulatie (n=267) werden ernstige bijwerkingen van welke oorzaak dan ook gemeld bij 70 (53%) van de 133 patiënten die TTFields-therapie plus standaardtherapie kregen en bij 51 (38%) van de 134 patiënten die alleen standaardtherapie kregen.
De meest voorkomende bijwerkingen van graad 3–4 waren leukopenie (37 [14%] van de 267), pneumonie (28 [10%]) en anemie (21 [8%]).
Bij 95 (71%) van de 133 patiënten werden bijwerkingen gemeld gerelateerd aan TTFields-therapie; dit betrof voornamelijk (81 [85%)) huid- en onderhuidaandoeningen van graad 1-2.
Er waren drie sterfgevallen gerelateerd aan de standaardtherapie (twee door infecties en één door longbloeding) en geen sterfgevallen gerelateerd aan TTFields-therapie.

Conclusie:
TTFields-therapie toegevoegd aan de standaardtherapie verbeterde de algehele overleving significant vergeleken met alleen standaardtherapie bij gemetastaseerde niet-kleincellige longkanker na progressie op platina-gebaseerde therapie, zonder verergering van systemische toxiciteit. Deze gegevens suggereren dat TTFields-therapie effectief is bij gemetastaseerde niet-kleincellige longkanker en overwogen dient te worden als behandeloptie voor de behandeling van de ziekte in deze setting.

Het volledige studieverslag is gegen betaling in te zien of te downloaden. Hier het abstract zoals gepubliceerd in The Lancet:

ArticlesVolume 24, Issue 9p1002-1017September 2023

Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study

Ticiana Leal, MD a ticiana.a.leal@emory.edu ∙ Prof Rupesh Kotecha, MD b ∙ Rodryg Ramlau, MD c ∙ Li Zhang, MD d ∙ Prof Janusz Milanowski, MD e ∙ Manuel Cobo, MD f ∙ et al. Show more

Correction:

Errata

Correction to Lancet Oncol 2023; 24: 1002–17

May 28, 2024

Summary

Background

Tumor Treating Fields (TTFields) are electric fields that disrupt processes critical for cancer cell survival, leading to immunogenic cell death and enhanced antitumour immune response. In preclinical models of non-small-cell lung cancer, TTFields amplified the effects of chemotherapy and immune checkpoint inhibitors. We report primary results from a pivotal study of TTFields therapy in metastatic non-small-cell lung cancer.

Methods

This randomised, open-label, pivotal phase 3 study recruited patients at 130 sites in 19 countries. Participants were aged 22 years or older with metastatic non-small-cell lung cancer progressing on or after platinum-based therapy, with squamous or non-squamous histology and ECOG performance status of 2 or less. Previous platinum-based therapy was required, but no restriction was placed on the number or type of previous lines of systemic therapy. Participants were randomly assigned (1:1) to TTFields therapy and standard systemic therapy (investigator's choice of immune checkpoint inhibitor [nivolumab, pembrolizumab, or atezolizumab] or docetaxel) or standard therapy alone. Randomisation was performed centrally using variable blocked randomisation and an interactive voice–web response system, and was stratified by tumour histology, treatment, and region. Systemic therapies were dosed according to local practice guidelines. TTFields therapy (150 kHz) was delivered continuously to the thoracic region with the recommendation to achieve an average of at least 18 h/day device usage. The primary endpoint was overall survival in the intention-to-treat population. The safety population included all patients who received any study therapy and were analysed according to the actual treatment received. The study is registered with ClinicalTrials.gov, NCT02973789.

Findings

Between Feb 13, 2017, and Nov 19, 2021, 276 patients were enrolled and randomly assigned to receive TTFields therapy with standard therapy (n=137) or standard therapy alone (n=139). The median age was 64 years (IQR 59–70), 178 (64%) were male and 98 (36%) were female, 156 (57%) had non-squamous non-small-cell lung cancer, and 87 (32%) had received a previous immune checkpoint inhibitor. Median follow-up was 10·6 months (IQR 6·1–33·7) for patients receiving TTFields therapy with standard therapy, and 9·5 months (0·1–32·1) for patients receiving standard therapy. Overall survival was significantly longer with TTFields therapy and standard therapy than with standard therapy alone (median 13·2 months [95% CI 10·3–15·5] vs 9·9 months [8·1–11·5]; hazard ratio 0·74 [95% CI 0·56–0·98]; p=0·035). In the safety population (n=267), serious adverse events of any cause were reported in 70 (53%) of 133 patients receiving TTFields therapy plus standard therapy and 51 (38%) of 134 patients receiving standard therapy alone. The most frequent grade 3–4 adverse events were leukopenia (37 [14%] of 267), pneumonia (28 [10%]), and anaemia (21 [8%]). TTFields therapy-related adverse events were reported in 95 (71%) of 133 patients; these were mostly (81 [85%]) grade 1–2 skin and subcutaneous tissue disorders. There were three deaths related to standard therapy (two due to infections and one due to pulmonary haemorrhage) and no deaths related to TTFields therapy.

Interpretation

TTFields therapy added to standard therapy significantly improved overall survival compared with standard therapy alone in metastatic non-small-cell lung cancer after progression on platinum-based therapy without exacerbating systemic toxicities. These data suggest that TTFields therapy is efficacious in metastatic non-small-cell lung cancer and should be considered as a treatment option to manage the disease in this setting.

Funding

Novocure.

References

Hendriks, LE ∙ Kerr, KM ∙ Menis, J ∙ et al.

Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up

Ann Oncol. 2023; 34:358-376

Summary

Background

Methods

Findings

Interpretation

Funding

References

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