UKINETS2018 Oral Communications (1) (3 abstracts)
Lanreotide depot/autogel before, during, and after peptide receptor radionuclide therapy (PRRT) in advanced neuroendocrine tumors (NETs): Data from the PRELUDE study
Vikas Prasad 1 , Raj Srirajaskanthan 2 , Christos Toumpanakis 3 , Chiara Maria Grana 4 , Sergio Baldari 5 , Tahir Shah 6 , Angela Lamarca 7 , Frédéric Courbon 8 , Klemens Scheidhauer 9 , Eric Baudin 10 , Xuan Mai Truong Thanh 11 , Aude Houchard 11 & Lisa Bodei 12
1Universitätsklinikum Ulm, Ulm, Germany; 2Kings College Hospital, London, UK; 3Neuroendocrine Tumour Unit, Royal Free Hospital, London, UK; 4European Institute of Oncology, Milan, Italy; 5University of Messina, Messina, Italy; 6Queen Elizabeth Hospital Birmingham, Birmingham, UK; 7The Christie NHS Foundation Trust, Manchester, UK; 8IUCT-Oncopole, Toulouse, France; 9Technical University Muenchen, Klinikum rd. Isar, Munich, Germany; 10Institut Gustave Roussy, Villejuif, France; 11Ipsen, Boulogne Billancourt, France; 12Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Background: PRRT, licensed for gastroenteropancreatic (GEP) NETs, has been used with somatostatin analogues such as lanreotide autogel (LAN). PRELUDE is the first international, multicentre retrospective study, with central radiology reading, to describe use of LAN with PRRT (LAN-PRRT) in advanced NETs.
Methods: PRELUDE (NCT02788578) was an international, retrospective, non-comparative analysis of medical records of patients receiving LAN with 177Lu-DOTATATE/DOTATOC, and 12-month LAN only follow-up. Four UK sites participated. Key inclusion criteria: metastatic/locally advanced, grade 1/2, somatostatin receptor positive GEP or lung NET, progressive disease (PD) in the year prior to LAN-PRRT start, ≥1 LAN injection 8 wks before the 1 LAN-PRRT cycle, continuous LAN use during LAN-PRRT, cumulative PRRT activity ≥500 mCi. Primary endpoint: progression-free survival (PFS) rate from day 1 of 1st cycle to the end of the last LAN-PRRT cycle (RECISTv1.1, centrally assessed). Secondary endpoints included best overall response (OR; RECISTv1.1), objective response rate (ORR), change from baseline in diarrhoea and flushing. Safety included incidence of nephro, hemato and hepatotoxicity; vomiting during infusion.
Results: Enrollment was terminated early (insufficient recruitment). Of 40 patients enrolled, 39 had GEP NET (incl.; ileum 33.3%, unknown origin 25.6%, right colon 20.5%, pancreas 10.3%); one had lung NET (full analysis set: GEP NET n=23, lung NET n=1). 30 patients enrolled were from the UK. Most patients with GEP NET had Ki67 > 2-≤20% (53.1%), global overall Krenning score (centrally assessed) grade 4 (70.4%), received 4 (17/23 patients) LAN-PRRT cycles, and 120 mg LAN (18/23) last dose before PRRT. Median (range) LAN exposure: 37.0 (13.2, 90.0) mo overall; 12.6 (6.1, 32.5) mo during LAN only follow-up. PFS rate [95% CI]: 91.7% [53.9–98.8]. Best OR (GEP NET): 34.8% partial response, 60.9% stable disease, 4.3% PD. ORR at time of last LAN-PRRT cycle [95% CI]: 27.3% [13.2; 48.2]. Most patients with GEP NET had stable/improved diarrhoea (15/15) and flushing (13/14). Few toxicities reported; no safety issues identified.
Conclusion: Effectiveness data were encouraging in this selected population. In clinical practice, LAN use is considered before, during, and after PRRT. This study was sponsored by Ipsen.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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