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Influence of 18F-FDG PET/CT on clinical management and outcome in patients with advanced melanoma not primarily selected for surgery based on a linked evidence approach

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European Journal of Nuclear Medicine and Molecular Imaging Aims and scope Submit manuscript

Abstract

Purpose

To evaluate the clinical benefit of positron emission tomography (PET)/computed tomography (CT) in patients with advanced melanoma, primarily not selected for surgery based on management changes and survival data using the linked evidence approach (LEA).

Methods

A total of 201 18F-FDG PET/CT examinations (n = 33, stage III and n = 168, stage IV) in 119 melanoma patients, primarily not scheduled for surgery, were analysed regarding their impact on clinical management. Patients were selected from a prospective oncological PET/CT registry. The three PET/CT indication groups included unclear lesions in conventional imaging (n = 8), routine follow-up after multiple surgeries (n = 115) and therapy response evaluation of systemic therapy (n = 78). PET/CT-induced management changes were categorized either as major (change from follow-up to surgical or systemic treatment or vice versa, change from surgery to systemic therapy or vice versa) or minor (modifications in systemic therapy). The expected benefit of changes was determined via the linked evidence approach (LEA) connecting registry data, outcome data including overall survival and evidence of diagnostic accuracy of PET/CT based on existing literature.

Results

Related to the total study cohort, a change of management after PET/CT was observed in 48% of scans, including 10% minor and 38% major changes. Major changes involved a shift either from follow-up (33/201) or therapy pause (7/201) to systemic therapy, to surgical or other local therapy (26/201) and BSC (2/201). Nine out of 201 cases resulted in treatment pause of systemic therapy. We could confirm the prognostic value of PET/CT-based management by observing a 5-year survival rate more than roughly doubled in patients followed up after tumour exclusion or under local therapy compared with patients under systemic therapy. We could argue for a patient benefit from PET/CT-based management changes using results on accuracy and therapeutic effects from the literature.

Conclusion

The use of PET/CT in advanced melanoma patients, primarily not considered for surgery, resulted in frequent changes of management associated with a relevant expected clinical benefit especially in patients classified by PET/CT as tumour-free or eligible for radical surgery.

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Abbreviations

CI:

Confidence interval

CM:

Contrast media

18F-FDG PET/CT:

18-Fluorine fluorodeoxyglucose positron emission tomography/computed tomography

fig:

Figure

i.v.:

Intravenous

GCP:

Good clinical practice

HR:

Hazard ratio

LDH:

Lactate dehydrogenase

LEA:

Linked evidence approach

MBq:

Megabecquerel

mg/dl:

Milligramme/decilitre

OP:

Operation

OS:

Overall survival

PFS:

Progression-free survival

RCT:

Randomized clinical trial

RFA:

Radiofrequency ablation

S-100:

S-100 protein

sn:

Sensitivity

SUVavg:

Average standard-uptake value average

sp.:

Specificity

tab:

Table

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Acknowledgements

First, we thank all the patients who agreed to participate in the registry. Furthermore, we want to thank the staff of the PET/CT centre and Radiopharmacy of the Tuebingen University for their continuous support in patient care. Special thanks to our referring dermatologists who provided us with excellent clinical data for our study group.

Funding

This study was funded by the young scientists’ programme of the German Network “Health Services Research Baden-Wuerttemberg” of the Ministry of Science, Research and Arts in collaboration with the Ministry of Employment and Social Order, Family, Women and Senior Citizens, Baden-Wuerttemberg. Additional financial support was provided through the Wilhelm Sander Foundation (Wilhelm Sander-Stiftung, Goethestraße 74, 80336 Munich, Germany, project-number 2015.176.1).

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Correspondence to Susann-Cathrin Olthof.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was reviewed and approved by the institutional review board and the local ethics committee (reference number 064/2013BO1).

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Informed consent was obtained from all individual participants included in the study.

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This article is part of the Topical Collection on Miscellanea

Electronic supplementary material

ESM 1

Supplementary Figure Sequence of data retrieval for the prospective PET/CT registry (PPTX 38 kb)

ESM 2

Supplementary Table Details of the applied systemic therapies in 87 patients with advanced melanoma (DOCX 12 kb)

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Olthof, SC., Forschner, A., Martus, P. et al. Influence of 18F-FDG PET/CT on clinical management and outcome in patients with advanced melanoma not primarily selected for surgery based on a linked evidence approach. Eur J Nucl Med Mol Imaging 47, 2313–2321 (2020). https://doi.org/10.1007/s00259-020-04733-x

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  • DOI: https://doi.org/10.1007/s00259-020-04733-x

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