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External Validity of Somatostatin Analogs Trials in Advanced Neuroendocrine Neoplasms: The GETNE-TRASGU Study
- Source :
- Neuroendocrinology, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, Jimenez-fonseca, P, Carmona-bayonas, A, Lamarca, A, Barriuso, J, Castaño, A, Benavent, M, Alonso, V, Riesco, M D C, Alonso-gordoa, T, Custodio, A, Sanchez Canovas, M, Hernando, J, López, C, La Casta, A, Fernandez Montes, A, Marazuela, M, Crespo, G, Diaz, J A, Feliciangeli, E, Gallego, J, Llanos, M, Segura, A, Vilardell, F, Percovich, J C, Grande, E, Capdevila, J, Valle, J & Garcia-carbonero, R 2021, ' External validity of somatostatin analogues trials in advanced neuroendocrine neoplasms: the GETNE-TRASGU study ', Neuroendocrinology, vol. 0, 0 . https://doi.org/10.1159/000514808, r-FISABIO. Repositorio Institucional de Producción Científica
- Publication Year :
- 2022
- Publisher :
- S. Karger AG, 2022.
-
Abstract
- [Introduction] Somatostatin analogs (SSA) prolong progression-free survival (PFS) in patients with well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). However, the eligibility criteria in randomized clinical trials (RCTs) have been restricted, which contrasts with the vast heterogeneity found in NENs.<br />[Methods] We identified patients with well-differentiated (Ki-67% ≤20%), metastatic GEP-NENs treated in first line with SSA monotherapy from the Spanish R-GETNE registry. The therapeutic effect was evaluated using a Bayesian Cox model. The objective was to compare survival-based outcomes from real-world clinical practice versus RCTs.<br />[Results] The dataset contained 535 patients with a median age of 62 years (range: 26–89). The median Ki-67% was 4 (range: 0–20). The most common primary tumor sites were as follows: midgut, 46%; pancreas, 34%; unknown primary, 10%; and colorectal, 10%. Half of the patients received octreotide LAR (n = 266) and half, lanreotide autogel (n = 269). The median PFS was 28.0 months (95% CI: 22.1–32.0) for octreotide versus 30.1 months (95% CI: 23.1–38.0) for lanreotide. The overall hazard ratio for lanreotide versus octreotide was 0.90 (95% credible interval: 0.71–1.12). The probability of effect sizes >30% with lanreotide versus octreotide was 2 and 6% for midgut and foregut NENs, respectively.<br />[Conclusion] Our study evaluated the external validity of RCTs examining SSAs in the real world, as well as the main effect-modifying factors (progression status, symptoms, tumor site, specific metastases, and analytical data). Our results indicate that both octreotide LAR and lanreotide autogel had a similar effect on PFS. Consequently, both represent valid alternatives in patients with well-differentiated, metastatic GEP-NENs.<br />The study has been funded by a restricted grant from Novartis Farmacéutica, S.A. RGETNE and the GETNE group is partially funded by Ipsen, Novartis, Pfizer and AAA. Dr Angela Lamarca received funding from ASCO Conquer Cancer Foundation Young Investigator Award and The Christie Charity. Dr Jorge Barriuso received funding from the received funding from the ENETS Centre of Excellence Fellowship Grant Award.
- Subjects :
- Male
Survival
Endocrinology, Diabetes and Metabolism
Octreotide
Neuroendocrine tumors
Lanreotide
Gastroenterology
Bayesian method
030218 nuclear medicine & medical imaging
law.invention
Somatostatin analog
chemistry.chemical_compound
0302 clinical medicine
Endocrinology
Randomized controlled trial
law
Medicine
Registries
Neoplasm Metastasis
Randomized Controlled Trials as Topic
Aged, 80 and over
Manchester Cancer Research Centre
Hazard ratio
Middle Aged
Prognosis
Primary tumor
Progression-Free Survival
Neuroendocrine Tumors
Somatostatin
Female
Neuroendocrine tumor
medicine.drug
Adult
medicine.medical_specialty
Antineoplastic Agents, Hormonal
030209 endocrinology & metabolism
Peptides, Cyclic
03 medical and health sciences
Cellular and Molecular Neuroscience
Stomach Neoplasms
Internal medicine
Intestinal Neoplasms
Humans
Aged
Endocrine and Autonomic Systems
business.industry
Proportional hazards model
ResearchInstitutes_Networks_Beacons/mcrc
Reproducibility of Results
medicine.disease
Pancreatic Neoplasms
chemistry
Spain
business
Subjects
Details
- Language :
- English
- ISSN :
- 00283835 and 14230194
- Database :
- OpenAIRE
- Journal :
- Neuroendocrinology, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, Jimenez-fonseca, P, Carmona-bayonas, A, Lamarca, A, Barriuso, J, Castaño, A, Benavent, M, Alonso, V, Riesco, M D C, Alonso-gordoa, T, Custodio, A, Sanchez Canovas, M, Hernando, J, López, C, La Casta, A, Fernandez Montes, A, Marazuela, M, Crespo, G, Diaz, J A, Feliciangeli, E, Gallego, J, Llanos, M, Segura, A, Vilardell, F, Percovich, J C, Grande, E, Capdevila, J, Valle, J & Garcia-carbonero, R 2021, ' External validity of somatostatin analogues trials in advanced neuroendocrine neoplasms: the GETNE-TRASGU study ', Neuroendocrinology, vol. 0, 0 . https://doi.org/10.1159/000514808, r-FISABIO. Repositorio Institucional de Producción Científica
- Accession number :
- edsair.doi.dedup.....edbb6eaf613cfb0cd25a206b7cfb8252