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European Journal of Nuclear Medicine and Molecular Imaging

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Open Access 01-09-2020 | Radionuclide Therapy | Original Article

Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice

Authors: Vikas Prasad, Raj Srirajaskanthan, Christos Toumpanakis, Chiara Maria Grana, Sergio Baldari, Tahir Shah, Angela Lamarca, Frédéric Courbon, Klemens Scheidhauer, Eric Baudin, Xuan-Mai Truong Thanh, Aude Houchard, Clarisse Dromain, Lisa Bodei

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 10/2020

Abstract

Purpose

PRELUDE aimed to assess use and effectiveness/safety of lanreotide autogel/depot (LAN) combined with ¹⁷⁷Lu-DOTATOC or ¹⁷⁷Lu-DOTATATE (LAN–peptide receptor radionuclide therapy [PRRT]) in patients with progressive neuroendocrine tumours (NETs).

Methods

International, non-interventional, retrospective, non-comparative analysis of medical records from patients with progressive metastatic or locally advanced grade 1 or 2 gastroenteropancreatic (GEP)- or lung-NETs. The primary endpoint was progression-free survival (PFS) at end of last LAN–PRRT cycle. Secondary endpoints included PFS at last available follow-up, best overall response, objective response rate (ORR), presence and severity of diarrhoea and flushing, and safety. Post-hoc analyses were conducted to determine pre-treatment tumour growth rate (TGR) cutoffs that best predicted the ORR during treatment.

Results

Forty patients were enrolled (GEP-NETs, n = 39; lung-NETs, n = 1). PFS rates were 91.7% at end of last LAN–PRRT cycle and 95.0% at last available follow-up. In the full analysis set, best overall response among patients with GEP-NETs (n = 23) was stable disease (n = 14, 60.9%), partial response (n = 8, 34.8%) and progressive disease (n = 1, 4.3%). The ORR was 27.3% at end of last LAN–PRRT cycle and 36.8% at last available follow-up. Optimal baseline TGR cutoffs for predicting ORR at these time points were 1.18% and 0.33%, respectively. At baseline, 81.0% of patients had diarrhoea or flushing; both remained stable or improved in most cases. No increased adverse drug reactions were reported.

Conclusion

Despite the major recruitment shortfall for the PRELUDE study, effectiveness data were encouraging in this selected population, highlighting the potential usefulness and feasibility of LAN combined with and after PRRT in patients with GEP-NETs. The study also identified challenges associated with evaluating clinical practice in a rare-disease setting and highlighted the need for standardisation of PRRT procedures.

Trial registration

Trial number: NCT02788578; URL: https://clinicaltrials.gov/ct2/show/NCT02788578

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Title: Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice
Authors: Vikas Prasad
Raj Srirajaskanthan
Christos Toumpanakis
Chiara Maria Grana
Sergio Baldari
Tahir Shah
Angela Lamarca
Frédéric Courbon
Klemens Scheidhauer
Eric Baudin
Xuan-Mai Truong Thanh
Aude Houchard
Clarisse Dromain
Lisa Bodei
Publication date: 01-09-2020
Publisher: Springer Berlin Heidelberg
Keyword: Radionuclide Therapy
Published in: European Journal of Nuclear Medicine and Molecular Imaging / Issue 10/2020
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-020-04712-2

At a glance: The STEP trials

Springer Medicine

Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

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