Efficacy of octreotide long-acting repeatable in neuroendocrine tumors: RADIANT-2 placebo arm post hoc analysis.

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.

• Authors: Jonathan R Strosberg, James C Yao, Emilio Bajetta, Mounir Aout, Bert Bakker, John D Hainsworth, Philippe B Ruszniewski, Eric Van Cutsem, Kjell Öberg, Marianne E Pavel
• Journal: Endocrine-related cancer (Endocr Relat Cancer) Vol. 22 Issue 6 Pg. 933-40 (Dec 2015) ISSN: 1479-6821 [Electronic] England
• PMID: 26373569 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The authors.

Chemical References

• Antineoplastic Agents, Hormonal
• Delayed-Action Preparations
• Placebos
• Everolimus
• Octreotide

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (administration & dosage, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Delayed-Action Preparations
• Disease-Free Survival
• Double-Blind Method
• Everolimus (administration & dosage)
• Female
• Gastrointestinal Neoplasms (drug therapy, mortality)
• Humans
• Kaplan-Meier Estimate
• Male
• Malignant Carcinoid Syndrome (drug therapy)
• Middle Aged
• Neuroendocrine Tumors (drug therapy, mortality)
• Octreotide (administration & dosage, therapeutic use)
• Placebos
• Treatment Outcome