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Impact of Previous Somatostatin Analogue Use on the Activity of Everolimus in Patients with Advanced Neuroendocrine Tumors: Analysis from the Phase III RADIANT-2 Trial
Univ Kentucky, Markey Canc Ctr, Div Med Oncol, Lexington, KY 40536 USA..
Charite, Campus Virchow Klinikum, D-13353 Berlin, Germany..
Sarah Cannon Res Inst, Nashville, TN USA..
H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA..
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2015 (English)In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 102, no 1-2, 18-25 p.Article in journal (Refereed) Published
Abstract [en]

Background/Aims: The phase III placebo-controlled RADI-ANT-2 trial investigated the efficacy of everolimus plus octreotide long-acting repeatable (LAR) in patients with advanced neuroendocrine tumors (NET) associated with carcinoid syndrome. Here we report a secondary analysis based on the previous somatostatin analogue (SSA) exposure status of patients enrolled in RADIANT-2. Methods: Patients were randomly assigned to receive oral everolimus 10 mg/day plus octreotide LAR 30 mg intramuscularly (i.m.) or to receive matching placebo plus octreotide LAR 30 mg i.m. every 28 days. SSA treatment before study enrollment was permitted. Patient characteristics and progression-free survival (PFS) were analyzed by treatment arm and previous SSA exposure status. Results: Of the 429 patients enrolled in RADI-ANT-2, 339 were previously exposed to SSA (95% received octreotide); 173 of 339 patients were in the everolimus plus octreotide LAR arm. All patients had a protocol-specified history of secretory symptoms, but analysis by type showed that more patients who previously received SSA therapy had a history of flushing symptoms (77%), diarrhea (86%), or both (63%) compared with SSA-naive patients (62, 62, and 24%, respectively). Patients who received everolimus plus octreotide LAR had longer median PFS regardless of previous SSA exposure (with: PFS 14.3 months, 95% confidence interval, CI, 12.0-20.1; without: 25.2 months, 95% CI, 12.0-not reached) compared with patients who received placebo plus octreotide LAR (with: 11.1 months, 95% CI, 8.4-14.6; without: 13.6 months, 95% CI, 8.2-22.7). Conclusion: Everolimus in combination with octreotide improves PFS in patients with advanced NET associated with carcinoid syndrome, regardless of previous SSA exposure.

Place, publisher, year, edition, pages
2015. Vol. 102, no 1-2, 18-25 p.
Keyword [en]
Everolimus, Neuroendocrine tumors, Mammalian target of rapamycin, Octreotide long-acting repeatable, Progression-free survival, Somatostatin analogue
National Category
Endocrinology and Diabetes Neurosciences
URN: urn:nbn:se:uu:diva-265649DOI: 10.1159/000381715ISI: 000361683500003PubMedID: 25824001OAI: oai:DiVA.org:uu-265649DiVA: diva2:866408
Available from: 2015-11-02 Created: 2015-11-02 Last updated: 2015-11-02Bibliographically approved

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Öberg, Kjell
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