Sistema de Salut de Catalunya
Institut Català de la Salut
[Baudin E] Endocrine Oncology Unit, Imaging Department, Gustave Roussy, Villejuif, France. [Capdevila J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB Quirón-Teknon, Barcelona, Spain. [Hörsch D] ENETS Center of Excellence, Zentralklinik Bad Berka GmbH, Bad Berka, Germany. [Singh S] Division of Medical Oncology, University of Toronto, Sunnybrook Odette Cancer Center, Sunnybrook HSC, Toronto, Ontario, Canada. [Caplin ME] Neuroendocrine Tumour Unit, Royal Free Hospital School of Medicine, London, UK. [Wolin EM] Division of Hematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
Vall d'Hebron Barcelona Hospital Campus
2024-09-16T05:41:16Z
2024-09-16T05:41:16Z
2024-07-22
Atypical carcinoid; Bronchopulmonary neuroendocrine tumors; Typical carcinoid
Carcinoide atípic; Tumors neuroendocrins broncopulmonars; Carcinoide típic
Carcinoide atípico; Tumores neuroendocrinos broncopulmonares; Carcinoide típico
Prospective data are lacking on early somatostatin analog (SSA) therapy in bronchopulmonary neuroendocrine tumors (BP-NETs; typical carcinoids and atypical carcinoids (TCs and ACs)). SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC). Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs. Recruitment was stopped early owing to slow accrual; eligible patients from the double-blind phase transitioned to open-label LAN. The adapted primary endpoint was progression-free survival (PFS) during either phase for patients receiving LAN. Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)). Median (95% CI) PFS during double-blind and open-label phases in patients receiving LAN was 16.6 (11.3; 21.9) months overall (primary endpoint), 21.9 (12.8, not calculable (NC)) months in TCs, and 13.8 (5.4; 16.6) months in ACs. During double-blind treatment, median (95% CI) PFS was 16.6 (11.3; 21.9) months for LAN vs 13.6 (8.3; NC) months for placebo (not significant); corresponding values were 21.9 (13.8; NC) and 13.9 (13.4; NC) months, respectively, in TCs and 13.8 (5.4; 16.6) and 11.0 (2.8; 16.9) months, respectively, in ACs. Patients’ quality of life did not deteriorate and LAN was well tolerated. Although recruitment stopped early and the predefined sample size was not met, SPINET is the largest prospective study to date of SSA therapy in SSTR-positive TCs and ACs and suggests clinical benefit in TCs.
This work was supported by Ipsen.
Article
Published version
English
Pulmons - Càncer - Tractament; Tumors neuroendocrins - Tractament; Somatostatina - Ús terapèutic; CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Hypothalamic Hormones::Pituitary Hormone Release Inhibiting Hormones::Somatostatin; Other subheadings::Other subheadings::/therapeutic use; DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Germ Cell and Embryonal::Neuroectodermal Tumors::Neuroendocrine Tumors; DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms; Other subheadings::Other subheadings::Other subheadings::/drug therapy; COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas peptídicas::hormonas hipotalámicas::hormonas inhibidoras de la liberación de hormonas hipofisarias::somatostatina; Otros calificadores::Otros calificadores::/uso terapéutico; ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::tumores neuroendocrinos; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
Bioscientifica
Endocrine-Related Cancer;31(9)
https://doi.org/10.1530/ERC-23-0337
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
