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

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

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Published in:European journal of nuclear medicine and molecular imaging 2020-09, Vol.47 (10), p.2358-2371
Main Authors: Prasad, Vikas, Srirajaskanthan, Raj, Toumpanakis, Christos, Grana, Chiara Maria, Baldari, Sergio, Shah, Tahir, Lamarca, Angela, Courbon, Frédéric, Scheidhauer, Klemens, Baudin, Eric, Truong Thanh, Xuan-Mai, Houchard, Aude, Dromain, Clarisse, Bodei, Lisa
Format: Article
Language:English
Subjects:
Cardiology
Comparative analysis
Diarrhea
Endocrinology
Flushing
Growth rate
Health services
Humans
Imaging
Lungs
Lutetium isotopes
Medical records
Medicine
Medicine & Public Health
Metastases
Neuroendocrine tumors
Neuroendocrine Tumors - radiotherapy
Nuclear Medicine
Octreotide - adverse effects
Oncology
Original
Original Article
Orthopedics
Patients
Peptides
Peptides, Cyclic
Radiation therapy
Radioisotopes
Radiology
Rare diseases
Receptors
Receptors, Peptide
Retrospective Studies
Safety
Somatostatin - analogs & derivatives
Treatment Outcome
Tumors
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Summary:Purpose PRELUDE aimed to assess use and effectiveness/safety of lanreotide autogel/depot (LAN) combined with 177 Lu-DOTATOC or 177 Lu-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
ISSN:1619-7070
1619-7089
DOI:10.1007/s00259-020-04712-2