External Validity of Somatostatin Analogs Trials in Advanced Neuroendocrine Neoplasms: The GETNE-TRASGU Study.
Neuroendocrinology
; 112(1): 88-100, 2022.
Article
en En
| MEDLINE
| ID: mdl-33508849
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.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.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.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.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias Pancreáticas
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Péptidos Cíclicos
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Neoplasias Gástricas
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Somatostatina
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Octreótido
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Ensayos Clínicos Controlados Aleatorios como Asunto
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Sistema de Registros
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Tumores Neuroendocrinos
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Antineoplásicos Hormonales
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Supervivencia sin Progresión
Tipo de estudio:
Clinical_trials
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Prognostic_studies
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
País como asunto:
Europa
Idioma:
En
Año:
2022
Tipo del documento:
Article