Lanreotide depot/autogel (LAN) in midgut neuroendocrine tumors (NETs): A subgroup analysis from the CLARINET study.

Background: In CLARINET, progression-free survival (PFS) was significantly prolonged with the somatostatin analog LAN 120 mg vs. placebo in patients with metastatic grade 1 or 2 (Ki-67 <10%) non-functioning intestinal and pancreatic NETs (hazard ratio [HR] for progressive disease [PD]/death: 0.47 [95% CI: 0.30, 0.73]. Here, we more fully characterize treatment effects in the midgut subgroup (tumors of small intestine/appendix). Methods: CLARINET was a 96-week randomized double-blind trial. Patients received LAN 120 mg or placebo every 4 weeks, administered by deep subcutaneous 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: 73 patients with midgut NETs received LAN (n=33) or placebo (n=40). At baseline, mean age was 64 yrs, 34% had liver burdens >10% (19% with burdens >25%), 96% had stable disease, 88% had received no previous treatment, and 48% had undergone previous NET surgery. Median PFS in the midgut subgroup was not reached at study end with lanreotide vs. 21 months with placebo; treatment response was consistent in midgut NETs with liver tumor burdens above or below 10% (Table). Adverse events occurred at similar rates with lanreotide vs placebo (overall: 85 vs 93%; treatment-related: 42 vs 33%). Few patients on LAN or placebo had serious AEs (n=5 vs n=7; none treatment-related) or AE-related withdrawal (n=0 vs n=1). Conclusions: These data indicate antitumor effects and a favourable safety/tolerability profile that support LAN as a first-line midgut NET treatment. This is consistent with previous reports in the overall CLARINET study population. Clinical trial information: NCT00353496

Citation:
J Clin Oncol 33, 2015 (suppl; abstr 4104)

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