Lanreotide depot/autogel (LAN) in intestinal and pancreatic neuroendocrine tumors (NETs) according to body mass index (BMI): Subgroup analyses from the CLARINET study.

Background: CLARINET showed antitumor effects with LAN 120 mg in metastatic intestinal/pancreatic NETs. Here, we characterize treatment effects within subgroups defined post hoc by baseline BMI. Methods: CLARINET was a 96-wk randomized trial of patients with metastatic grade 1/2 (Ki-67 <10%) non-functioning intestinal/pancreatic NETs (NCT00353496). Patients received LAN 120 mg (N=101) or placebo (PBO; n=103) every 4 wks. Patient subgroups are based on well-known WHO BMI categories. Median progression-free survival (PFS) [95% CI] was determined by Kaplan–Meier method, and HRs and CIs with Cox proportional hazards model with single term for treatment (both intent-to-treat population); summary statistics were used for adverse events (AEs) (safety population). PFS analyses investigated only consistency of treatment effects across subgroups as the study was not otherwise powered for such analyses. Results: LAN median PFS was not reached in any BMI subgroup (vs 13–24 months for PBO); HRs favored LAN and were generally consistent with the overall population (Table). Incidences of AEs overall were similar across BMI and treatment groups; the most common AE was diarrhea (Table). Conclusions: CLARINET subgroup analyses suggest LAN has antitumor effects and a favorable safety/tolerability profile regardless of patient BMI. Clinical trial information: NCT00353496

Citation:
J Clin Oncol 33, 2015 (suppl; abstr e15182)

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