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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

5690 - Post-hoc analysis of CLARINET phase III study to investigate the influence of diabetic status on progression-free survival (PFS) of patients with neuroendocrine tumours (NETs) treated with lanreotide (LAN) or placebo (PBO)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Sara Pusceddu

Citation

Annals of Oncology (2018) 29 (suppl_8): viii467-viii478. 10.1093/annonc/mdy293

Authors

S. Pusceddu1, C. Vernieri1, M. Di Maio2, N. Prinzi3, M. Torchio1, R. Buzzoni1, X. Truong-Thanh4, V. Mazzaferro5, F.G.M. de Braud6

Author affiliations

  • 1 Medical Oncology, Enets Center Of Excellence, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Division Of Medical Oncology, "Ordine Mauriziano" Hospital, Torino/IT
  • 3 Medical Oncology Enets Center Of Excellence, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 4 Global Medical Affairs, Ipsen Pharma France, 92100 - Boulogne-Billancourt/FR
  • 5 Gastrointestinal Surgery And Liver Transplantation Department, Enets Center Of Excellence. University Of Milan., Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 6 Medical Oncology, Enets Center Of Excellence. University Of Milan, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
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Resources

Abstract 5690

Background

Diabetes mellitus (DM) is a risk factor for pancreatic NETs, but its prognostic role in stage IV NETs is less defined. We evaluated the impact of diabetes on PFS in patients with advanced, non-functioning GEP-NETs.

Methods

Post hoc analysis of data from the phase III double-blind, placebo-controlled CLARINET study (NCT00353496) to investigate association between DM (any of: medical history of type 1 or 2; use of antihyperglycemic medication; HbA1c ≥6.5%, fasting plasma glucose ≥7mmol/L; non-fasting plasma glucose ≥11.11mmol/L [at baseline or during study]) and PFS (Kaplan-Meier). Multivariate Cox analysis including treatment (LAN vs PBO), DM at baseline, previous therapy and progression at baseline was used to test interaction between DM and LAN efficacy.

Results

The overall population (total, n = 204; LAN, n = 101; PBO, n = 103) had well-differentiated (Ki-67 <10%) foregut (45%), midgut (36%), or hindgut (7%) and unknown (13%) NET. 79 patients had DM, 125 did not (N-DM); 24 received metformin in combination with LAN (n = 14) or PBO (n = 10). Median PFS (mPFS) was 96.0 months (mo) [95% CI: 70.4; not reached (NR)] for DM vs 98.0 mo [72.1;NR] for N-DM (HR 1.20 [0.79;1.82], p = 0.38). For DM, mPFS with LAN (n = 42) was NR [95.9;NR] vs 60.0 mo [48.0;74.4] with PBO (n = 37) (HR 0.27, [0.13-0.57], p = 0.0002). For N-DM, mPFS with LAN (n = 59) was NR [96.0;NR] vs 72.1 mo [52.0;NA] with PBO (n = 66) (HR 0.64 [0.35-1.15], p = 0.04). In multivariate analysis, DM at baseline was not significantly associated with PFS (HR 1.64 [0.95;2.84], p = 0.08). Significant impact of LAN on PFS was confirmed (HR 0.53 [0.31;0.89], p = 0.02), without significant interaction between LAN efficacy and DM (p = 0.62).

Conclusions

DM did not emerge as a negative prognostic factor in advanced stage IV NETs. Efficacy of LAN in DM and N-DM was confirmed. Although LAN–DM interaction was not significant, LAN efficacy seemed particularly favorable in DM compared to N-DM patients, in terms of HR. These findings, along with a potential favorable association with hypoglycemic drugs such as metformin, should be evaluated and validated in prospective biomarker studies.

Clinical trial identification

Post hoc analisys of phase III double-blind, placebo-controlled CLARINET study (NCT00353496).

Legal entity responsible for the study

Ipsen.

Funding

Ipsen.

Editorial Acknowledgement

Editorial assistance for the preparation of this abstract was provided by Emma Leah, Global Publications Manager, Rare Diseases, Ipsen.

Disclosure

S. Pusceddu: Honoraria, advisory boards: Novartis; Research funding, honoraria, advisory boards, consulting role, grants: Ipsen; Advisory boards: Italfarmaco; Research funding, advisory boards, grants: Pfizer; Advisory boards: Advanced Accelerate Application (AAA). R. Buzzoni: Research funding, advisory boards: Ipsen. F.G.M. de Braud: Research funding, honoraria, advisory boards, consulting role, grants: Ipsen. N. Prinzi: Honoraria: Ipsen. X-M. Truong-Thanh: Employment: Ipsen. V. Mazzaferro: Honoraria: Ipsen. All other authors have declared no conflicts of interest.

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