External validity of somatostatin analogs trials in advanced neuroendocrine neoplasms: The GETNE-TRASGU study
Jimenez-Fonseca, P. Carmona-Bayonas, A. Lamarca, Angela Barriuso, Jorge Castano, A. Benavent, M. Alonso, V. Riesco, M. D. Alonso-Gordoa, T. Custodio, A.
Jimenez-Fonseca, P.
Carmona-Bayonas, A.
Lamarca, Angela
Barriuso, Jorge
Castano, A.
Benavent, M.
Alonso, V.
Riesco, M. D.
Alonso-Gordoa, T.
Custodio, A.
Citations
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Abstract
Introduction: Somatostatin analogues (SSA) prolong progression-free survival (PFS) in patients with well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, the eligibility criteria in randomized clinical trials (RCTs) have been restricted, which contrasts with the vast heterogeneity found in NETs.
Methods: We identified patients with well-differentiated (Ki67% ?20%), metastatic GEP-NETs 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 Ki67% was 4 (range: 0-20). The most common primary tumor sites were: 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 vs 30.1 months (95% CI, 23.1-38.0) for lanreotide. The overall hazard ratio for lanreotide vs octreotide was 0.90 (95% credible interval, 0.71-1.12). The probability of effect sizes >30% with lanreotide vs 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.
Authors
Jimenez-Fonseca, P.
Carmona-Bayonas, A.
Lamarca, Angela
Barriuso, Jorge
Castano, A.
Benavent, M.
Alonso, V.
Riesco, M. D.
Alonso-Gordoa, T.
Custodio, A.
Canovas, M. S.
Hernando, J.
Lopez, C.
La Casta, A.
Montes, A. F.
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, Juan W
Garcia-Carbonero, R.
Carmona-Bayonas, A.
Lamarca, Angela
Barriuso, Jorge
Castano, A.
Benavent, M.
Alonso, V.
Riesco, M. D.
Alonso-Gordoa, T.
Custodio, A.
Canovas, M. S.
Hernando, J.
Lopez, C.
La Casta, A.
Montes, A. F.
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, Juan W
Garcia-Carbonero, R.
Description
Date
2021
Publisher
Collections
Keywords
Type
Article
Citation
Jimenez-Fonseca P, Carmona-Bayonas A, Lamarca A, Barriuso J, Casta�o A, Benavent M, et al. External validity of somatostatin analogues trials in advanced neuroendocrine neoplasms: the GETNE-TRASGU study. Neuroendocrinology. S. Karger AG; 2021.