title: 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.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany Jonathan.Strosberg@moffitt.org.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Strosberg
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: James C
authors.initials: JC
authors.lastname: Yao
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Emilio
authors.initials: E
authors.lastname: Bajetta
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Mounir
authors.initials: M
authors.lastname: Aout
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Bert
authors.initials: B
authors.lastname: Bakker
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: John D
authors.initials: JD
authors.lastname: Hainsworth
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Philippe B
authors.initials: PB
authors.lastname: Ruszniewski
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Kjell
authors.initials: K
authors.lastname: Öberg
authors.affiliation: Department of MedicineMoffitt Cancer Center, Tampa, Florida, USADivision of Cancer MedicineDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIstituto di OncologiaPoliclinico di Monza, Monza, ItalyNovartis International AGBasel, SwitzerlandNovartis Pharmaceuticals CorporationEast Hanover, New Jersey, USASarah Cannon Research InstituteNashville, Tennessee, USAUniversity of Paris VII and Beaujon HospitalParis, FranceDigestive OncologyUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, BelgiumUppsala University HospitalUppsala, SwedenDepartment of Hepatology and GastroenterologyCharité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Marianne E
authors.initials: ME
authors.lastname: Pavel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D018572:Disease-Free Survival; D004311:Double-Blind Method; D000068338:Everolimus / Q000008:administration & dosage; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008303:Malignant Carcinoid Syndrome / Q000188:drug therapy; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000401:mortality; D015282:Octreotide / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D010919:Placebos; D000068338:Everolimus; D015282:Octreotide
keywords: neuroendocrine tumors; octreotide LAR; progression-free survival; somatostatin analogues