Lanreotide depot/autogel (LAN) in patients with neuroendocrine tumors (NETs) aged ≤65 vs. >65 years: Subgroup analyses from the CLARINET study.

Background: The somatostatin analog LAN 120 mg significantly prolonged progression-free survival (PFS) vs. placebo (PBO) in patients with metastatic grade 1 or 2 (Ki-67 <10%) nonfunctioning intestinal and pancreatic NETs (hazard ratio [HR] for progressive disease [PD]/death: 0.47 [95% CI: 0.30, 0. 73]). This large trial (n=204) allows the examination of treatment effects within subgroups of interest. We now 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 subcutaneous injection (NCT00353496). Subgroup analyses were undertaken to investigate only the consistency of treatment effects, the study was not designed or powered for such analyses. Results: Median age (range) was 57 years (30–65 years) for those ≤65 years old, and 71 years (66–92 years) for those >65 years old. Other baseline characteristics were similar between 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 120 mg on PFS were similar for the two groups and there were no consistent differences in tolerability (Table). Overall, the most common adverse event was diarrhea (≤65 years: LAN 36%, PBO 32%; >65 years: LAN 33%, PBO 40%). Conclusions: Treatment effect with LAN 120 mg in terms of PFS was consistent across age groups. LAN tolerability/safety was favorable. Clinical trial information: NCT00353496