Lanreotide depot/autogel before, during, and after peptide receptor radionuclide therapy (PRRT) in advanced neuroendocrine tumors (NETs): Data from the PRELUDE study.

Authors

null

Vikas Prasad

Universitätsklinikum Ulm, Ulm, Germany

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 , Lisa Bodei

Organizations

Universitätsklinikum Ulm, Ulm, Germany, Kings College Hospital, London, United Kingdom, Neuroendocrine Tumour Unit, Royal Free Hospital, London, United Kingdom, European Institute of Oncology, Milan, Italy, University of Messina, Messina, Italy, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom, The Christie NHS Foundation Trust, Manchester, United Kingdom, IUCT-Oncopole, Toulouse, France, Technical University Muenchen, Klinikum r.d. Isar, Munich, Germany, Institut Gustave Roussy, Villejuif, France, Ipsen, Boulogne Billancourt, France, Ipsen, Boulogne-Billancourt, France, Memorial Sloan Kettering Cancer Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: PRRT, licensed for gastroenteropancreatic (GEP) NETs, has been used with somatostatin analogs such as lanreotide depot (LAN). PRELUDE is the first retrospective study to describe use of LAN with PRRT (LAN–PRRT) in advanced NETs. Methods: PRELUDE was an international, retrospective, non-comparative analysis of medical records of patients receiving LAN with 177Lu-DOTATATE/DOTATOC, and 12 mo LAN only follow-up. 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 1st 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 diarrhea 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). 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 120mg 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 diarrhea (15/15) and flushing (13/14). Few toxicities reported; no safety issues identified. Conclusions: Effectiveness data were encouraging in this selected population. In clinical practice, LAN use is considered before, during, and after PRRT. Clinical trial information: NCT02788578

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Neuroendocrine/Carcinoid

Clinical Trial Registration Number

NCT02788578

Citation

J Clin Oncol 36, 2018 (suppl; abstr e16167)

DOI

10.1200/JCO.2018.36.15_suppl.e16167

Abstract #

e16167

Abstract Disclosures

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