Effects of lanreotide autogel/depot (LAN) in patients with neuroendocrine tumors (NETs) age 65 or younger versus older than age 65: Subgroup analyses from the CLARINET study.

Abstract

367 Background: The somatostatin analog lanreotide Autogel 120 mg significantly prolonged progression-free survival (PFS) vs. placebo (PBO) in patients with metastatic grade 1 or 2 (Ki-67 <10%) non-functioning enteropancreatic NETs (hazard ratio [HR] for progressive disease [PD]/death: 0.47 [95% CI: 0.30, 0.73]). The large size of the trial (n=204) affords an opportunity to examine treatment effects within subgroups of particular interest. Here, we compare PFS and safety data for patients aged ≤65 years vs. aged >65 years. Methods: In this 96-week randomized double-blind trial, patients received LAN 120 mg or PBO every 4 weeks by deep s.c. injection (NCT00353496). Subgroup analyses were undertaken to investigate only the consistency of treatment effects as the study was not otherwise designed or powered for such analyses. Results: Median age (range) was 57 years (30, 65) for thegroup aged ≤65 years and 71 years (66, 92) for the group aged >65 years. Other baseline characteristics were similar between age groups, including tumor origins (≤65 years: pancreatic 43%, midgut 34%; >65 years: pancreatic 46%, midgut 38%) and hepatic tumor loads (>25%: 30% and 37% for ≤65 and >65 years, respectively). Disease was predominantly stable at baseline (94% vs. 98%, respectively). Therapeutic effects of LAN on PFS were similar for the age groups and there were no consistent differences in tolerabilities between age groups (Table). The most common AE was diarrhea irrespective of age and treatment (≤65 years: LAN 36%, PBO 32%; >65 years: LAN 33%, PBO 40%). Conclusions: The treatment effect with LAN in terms of PFS was consistent across age groups and LAN tolerability/safety was favorable in both cases. Clinical trial information: NCT00353496. [Table: see text]