Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine

Solfrid Thunold; Eivor Hernes; Saima Farooqi; Åsa Kristina Öjlert; Roslyn J. Francis; Anna K. Nowak; Weronika Maria Szejniuk; Søren Steen Nielsen; Susana Cedres; Marc Simo Perdigo; Jens Benn Sørensen; Carin Meltzer; Lars Tore Gyland Mikalsen; Åslaug Helland; Eirik Malinen; Vilde Drageset Haakensen

doi:10.1007/s00259-024-06853-0

Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine

Solfrid Thunold^*, Eivor Hernes, Saima Farooqi, Åsa Kristina Öjlert, Roslyn J. Francis, Anna K. Nowak, Weronika Maria Szejniuk, Søren Steen Nielsen, Susana Cedres, Marc Simo Perdigo, Jens Benn Sørensen, Carin Meltzer, Lars Tore Gyland Mikalsen, Åslaug Helland, Eirik Malinen, Vilde Drageset Haakensen

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Abstract

Purpose
The introduction of immunotherapy in pleural mesothelioma (PM) has highlighted the need for effective outcome predictors. This study explores the role of [18F]FDG PET/CT in predicting outcomes in PM treated with immunotherapy.

Methods
Patients from the NIPU trial, receiving ipilimumab and nivolumab +/- telomerase vaccine in second-line, were included. [18F]FDG PET/CT was obtained at baseline (n = 100) and at week-5 (n = 76). Metabolic tumour volume (MTV) and peak standardised uptake value (SUVpeak) were evaluated in relation to survival outcomes. Wilcoxon rank-sum test was used to assess differences in MTV, total lesion glycolysis (TLG), maximum standardised uptake value (SUVmax) and SUVpeak between patients exhibiting an objective response, defined as either partial response or complete response according to the modified Response Criteria in Solid Tumours (mRECIST) and immune RECIST (iRECIST), and non-responders, defined as either stable disease or progressive disease as their best overall response.

Results
Univariate Cox regression revealed significant associations of MTV with OS (HR 1.36, CI: 1.14, 1.62, p < 0.001) and PFS (HR 1.18, CI: 1.03, 1.34, p = 0.02), while multivariate analysis showed a significant association with OS only (HR 1.35, CI: 1.09, 1.68, p = 0.007). While SUVpeak was not significantly associated with OS or PFS in univariate analyses, it was significantly associated with OS in multivariate analysis (HR 0.43, CI: 0.23, 0.80, p = 0.008). Objective responders had significant reductions in TLG, SUVmax and SUVpeak at week-5.

Conclusion
MTV provides prognostic value in PM treated with immunotherapy. High SUVpeak was not associated with inferior outcomes, which could be attributed to the distinct mechanisms of immunotherapy. Early reductions in PET metrics correlated with treatment response.

Study registration
The NIPU trial (NCT04300244) is registered at clinicaltrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT04300244?cond=Pleural+Mesothelioma&cntry=NO&draw=2&rank=4

Originalsprog	Engelsk
Tidsskrift	European Journal of Nuclear Medicine and Molecular Imaging
Vol/bind	52
Udgave nummer	2
Sider (fra-til)	693–707
Antal sider	15
ISSN	1619-7070
DOI	https://doi.org/10.1007/s00259-024-06853-0
Status	Udgivet - jan. 2025

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Thunold et al. (2025). Outcome prediction based on [18F]FDG PET-CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +- UV1 telomerase vaccineForlagets udgivne version, 2,18 MBLicens: CC BY 4.0

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Thunold, S., Hernes, E., Farooqi, S., Öjlert, Å. K., Francis, R. J., Nowak, A. K., Szejniuk, W. M., Nielsen, S. S., Cedres, S., Perdigo, M. S., Sørensen, J. B., Meltzer, C., Mikalsen, L. T. G., Helland, Å., Malinen, E., & Haakensen, V. D. (2025). Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine. European Journal of Nuclear Medicine and Molecular Imaging, 52(2), 693–707. https://doi.org/10.1007/s00259-024-06853-0

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title = "Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine",

abstract = "Purpose The introduction of immunotherapy in pleural mesothelioma (PM) has highlighted the need for effective outcome predictors. This study explores the role of [18F]FDG PET/CT in predicting outcomes in PM treated with immunotherapy. Methods Patients from the NIPU trial, receiving ipilimumab and nivolumab +/- telomerase vaccine in second-line, were included. [18F]FDG PET/CT was obtained at baseline (n = 100) and at week-5 (n = 76). Metabolic tumour volume (MTV) and peak standardised uptake value (SUVpeak) were evaluated in relation to survival outcomes. Wilcoxon rank-sum test was used to assess differences in MTV, total lesion glycolysis (TLG), maximum standardised uptake value (SUVmax) and SUVpeak between patients exhibiting an objective response, defined as either partial response or complete response according to the modified Response Criteria in Solid Tumours (mRECIST) and immune RECIST (iRECIST), and non-responders, defined as either stable disease or progressive disease as their best overall response. Results Univariate Cox regression revealed significant associations of MTV with OS (HR 1.36, CI: 1.14, 1.62, p < 0.001) and PFS (HR 1.18, CI: 1.03, 1.34, p = 0.02), while multivariate analysis showed a significant association with OS only (HR 1.35, CI: 1.09, 1.68, p = 0.007). While SUVpeak was not significantly associated with OS or PFS in univariate analyses, it was significantly associated with OS in multivariate analysis (HR 0.43, CI: 0.23, 0.80, p = 0.008). Objective responders had significant reductions in TLG, SUVmax and SUVpeak at week-5. Conclusion MTV provides prognostic value in PM treated with immunotherapy. High SUVpeak was not associated with inferior outcomes, which could be attributed to the distinct mechanisms of immunotherapy. Early reductions in PET metrics correlated with treatment response. Study registration The NIPU trial (NCT04300244) is registered at clinicaltrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT04300244?cond=Pleural+Mesothelioma\&cntry=NO\&draw=2\&rank=4",

keywords = "Immunotherapy, MTV, Pleural mesothelioma, SUV, Telomerase vaccine, [18F]FDG PET",

author = "Solfrid Thunold and Eivor Hernes and Saima Farooqi and {\"O}jlert, \{{\AA}sa Kristina\} and Francis, \{Roslyn J.\} and Nowak, \{Anna K.\} and Szejniuk, \{Weronika Maria\} and Nielsen, \{S{\o}ren Steen\} and Susana Cedres and Perdigo, \{Marc Simo\} and S{\o}rensen, \{Jens Benn\} and Carin Meltzer and Mikalsen, \{Lars Tore Gyland\} and {\AA}slaug Helland and Eirik Malinen and Haakensen, \{Vilde Drageset\}",

note = "{\textcopyright} 2024. The Author(s).",

year = "2025",

month = jan,

doi = "10.1007/s00259-024-06853-0",

language = "English",

volume = "52",

pages = "693–707",

journal = "European Journal of Nuclear Medicine and Molecular Imaging",

issn = "1619-7070",

publisher = "Springer",

number = "2",

}

Thunold, S, Hernes, E, Farooqi, S, Öjlert, ÅK, Francis, RJ, Nowak, AK, Szejniuk, WM, Nielsen, SS, Cedres, S, Perdigo, MS, Sørensen, JB, Meltzer, C, Mikalsen, LTG, Helland, Å, Malinen, E & Haakensen, VD 2025, 'Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine', European Journal of Nuclear Medicine and Molecular Imaging, bind 52, nr. 2, s. 693–707. https://doi.org/10.1007/s00259-024-06853-0

Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine. / Thunold, Solfrid; Hernes, Eivor; Farooqi, Saima et al.
I: European Journal of Nuclear Medicine and Molecular Imaging, Bind 52, Nr. 2, 01.2025, s. 693–707.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine

AU - Thunold, Solfrid

AU - Hernes, Eivor

AU - Farooqi, Saima

AU - Öjlert, Åsa Kristina

AU - Francis, Roslyn J.

AU - Nowak, Anna K.

AU - Szejniuk, Weronika Maria

AU - Nielsen, Søren Steen

AU - Cedres, Susana

AU - Perdigo, Marc Simo

AU - Sørensen, Jens Benn

AU - Meltzer, Carin

AU - Mikalsen, Lars Tore Gyland

AU - Helland, Åslaug

AU - Malinen, Eirik

AU - Haakensen, Vilde Drageset

PY - 2025/1

Y1 - 2025/1

N2 - Purpose The introduction of immunotherapy in pleural mesothelioma (PM) has highlighted the need for effective outcome predictors. This study explores the role of [18F]FDG PET/CT in predicting outcomes in PM treated with immunotherapy. Methods Patients from the NIPU trial, receiving ipilimumab and nivolumab +/- telomerase vaccine in second-line, were included. [18F]FDG PET/CT was obtained at baseline (n = 100) and at week-5 (n = 76). Metabolic tumour volume (MTV) and peak standardised uptake value (SUVpeak) were evaluated in relation to survival outcomes. Wilcoxon rank-sum test was used to assess differences in MTV, total lesion glycolysis (TLG), maximum standardised uptake value (SUVmax) and SUVpeak between patients exhibiting an objective response, defined as either partial response or complete response according to the modified Response Criteria in Solid Tumours (mRECIST) and immune RECIST (iRECIST), and non-responders, defined as either stable disease or progressive disease as their best overall response. Results Univariate Cox regression revealed significant associations of MTV with OS (HR 1.36, CI: 1.14, 1.62, p < 0.001) and PFS (HR 1.18, CI: 1.03, 1.34, p = 0.02), while multivariate analysis showed a significant association with OS only (HR 1.35, CI: 1.09, 1.68, p = 0.007). While SUVpeak was not significantly associated with OS or PFS in univariate analyses, it was significantly associated with OS in multivariate analysis (HR 0.43, CI: 0.23, 0.80, p = 0.008). Objective responders had significant reductions in TLG, SUVmax and SUVpeak at week-5. Conclusion MTV provides prognostic value in PM treated with immunotherapy. High SUVpeak was not associated with inferior outcomes, which could be attributed to the distinct mechanisms of immunotherapy. Early reductions in PET metrics correlated with treatment response. Study registration The NIPU trial (NCT04300244) is registered at clinicaltrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT04300244?cond=Pleural+Mesothelioma&cntry=NO&draw=2&rank=4

AB - Purpose The introduction of immunotherapy in pleural mesothelioma (PM) has highlighted the need for effective outcome predictors. This study explores the role of [18F]FDG PET/CT in predicting outcomes in PM treated with immunotherapy. Methods Patients from the NIPU trial, receiving ipilimumab and nivolumab +/- telomerase vaccine in second-line, were included. [18F]FDG PET/CT was obtained at baseline (n = 100) and at week-5 (n = 76). Metabolic tumour volume (MTV) and peak standardised uptake value (SUVpeak) were evaluated in relation to survival outcomes. Wilcoxon rank-sum test was used to assess differences in MTV, total lesion glycolysis (TLG), maximum standardised uptake value (SUVmax) and SUVpeak between patients exhibiting an objective response, defined as either partial response or complete response according to the modified Response Criteria in Solid Tumours (mRECIST) and immune RECIST (iRECIST), and non-responders, defined as either stable disease or progressive disease as their best overall response. Results Univariate Cox regression revealed significant associations of MTV with OS (HR 1.36, CI: 1.14, 1.62, p < 0.001) and PFS (HR 1.18, CI: 1.03, 1.34, p = 0.02), while multivariate analysis showed a significant association with OS only (HR 1.35, CI: 1.09, 1.68, p = 0.007). While SUVpeak was not significantly associated with OS or PFS in univariate analyses, it was significantly associated with OS in multivariate analysis (HR 0.43, CI: 0.23, 0.80, p = 0.008). Objective responders had significant reductions in TLG, SUVmax and SUVpeak at week-5. Conclusion MTV provides prognostic value in PM treated with immunotherapy. High SUVpeak was not associated with inferior outcomes, which could be attributed to the distinct mechanisms of immunotherapy. Early reductions in PET metrics correlated with treatment response. Study registration The NIPU trial (NCT04300244) is registered at clinicaltrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT04300244?cond=Pleural+Mesothelioma&cntry=NO&draw=2&rank=4

KW - Immunotherapy

KW - MTV

KW - Pleural mesothelioma

KW - SUV

KW - Telomerase vaccine

KW - [18F]FDG PET

UR - https://www.scopus.com/pages/publications/85201264245

U2 - 10.1007/s00259-024-06853-0

DO - 10.1007/s00259-024-06853-0

M3 - Journal article

C2 - 39133306

SN - 1619-7070

VL - 52

SP - 693

EP - 707

JO - European Journal of Nuclear Medicine and Molecular Imaging

JF - European Journal of Nuclear Medicine and Molecular Imaging

IS - 2

ER -

Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine

Abstract

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