Abstract
Somatostatin analogues (SSA) have demonstrated antiproliferative activity in addition to efficacy for carcinoid symptom control in functional neuroendocrine tumors (NET). A post hoc analysis of the placebo arm of the RAD001 In Advanced Neuroendocrine Tumors-2 (RADIANT-2) study was conducted to assess the efficacy of octreotide long-acting repeatable (LAR) on progression-free survival (PFS) and overall survival (OS) estimated using the Kaplan–Meier method. Out of 213 patients randomized to placebo plus octreotide LAR in RADIANT-2, 196 patients with foregut, midgut, or hindgut NET were considered for present analysis. Of these, 41 patients were SSA-treatment naïve and 155 had received SSA therapy before study entry. For SSA-naïve patients, median PFS by adjudicated central review was 13.6 (95% CI 8.2–22.7) months. For SSA-naïve patients with midgut NET (n=24), median PFS was 22.2 (95% CI 8.3–29.5) months. For patients who had received SSA previously, the median PFS was 11.1 (95% CI 8.4–14.3) months. Among the SSA-pretreated patients who had midgut NET (n=119), the median PFS was 12.0 (95% CI 8.4–19.3) months. Median OS was 35.8 (95% CI 32.5–48.9) months for patients in the placebo plus octreotide LAR arm; 50.6 (36.4 – not reached) months for SSA-naïve patients and 33.5 (95% CI 27.5–44.7) months for those who had received prior SSA. This post hoc analysis of the placebo arm of the large phase 3 RADIANT-2 study provides data on PFS and OS among patients with progressive NET treated with octreotide therapy.
Highlights
Neuroendocrine tumors (NET) are a rare, heterogeneous group of tumors that arise from neuroendocrine cells throughout the body and are capable of producing various bioactive substances such as peptides and amines (Yao et al 2008, Vinik et al 2010)
The time since initial diagnosis was longer for patients who received previous Somatostatin analogues (SSA) therapy; 7% of patients in the previous SSA group had a diagnosis of NET within 6 months prior to study entry, compared with 24% of patients in the SSA-naıve group
The post hoc analysis of the placebo arm of large phase 3 RADIANT-2 study, for the first time, provides data on progression-free survival (PFS) and overall survival (OS) from a prospective study among patients with progressive NET treated with octreotide therapy
Summary
Neuroendocrine tumors (NET) are a rare, heterogeneous group of tumors that arise from neuroendocrine cells throughout the body and are capable of producing various bioactive substances such as peptides and amines (Yao et al 2008, Vinik et al 2010). Octreotide and lanreotide have demonstrated anti-proliferative activity in pivotal phase 3 trials (Rinke et al 2009, Caplin et al 2014a). In the landmark PROMID (Placebo-controlled, double-blind, prospective, Randomized study of the effect of octreotide long-acting repeatable (LAR) in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors; nZ85) study, octreotide LAR (30 mg intramuscularly every 28 days) demonstrated antitumor activity in patients with newly diagnosed advanced metastatic NET of midgut origin. In the more recent phase 3 CLARINET study (nZ204), patients with advanced NET treated with lanreotide autogel (120 mg via deep s.c. injection every 28 days) had improvement in progression-free survival (PFS) when compared with placebo (PFS, not reached (NR) vs 18 months and HR, 0.47; 95% Cl 0.30–0.73; P!0.001) (Caplin et al 2014a)
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