External validity of somatostatin analogues trials in advanced neuroendocrine neoplasms: the GETNE-TRASGU study

Paula Jimenez-fonseca, Alberto Carmona-bayonas, Angela Lamarca, Jorge Barriuso, Angel Castaño, Marta Benavent, Vicente Alonso, Maria Del Carmen Riesco, Teresa Alonso-gordoa, Ana Custodio, Manuel Sanchez Canovas, Jorge Hernando, Carlos López, Adelaida La Casta, Ana Fernandez Montes, Mónica Marazuela, Guillermo Crespo, Jose Angel Diaz, Eduardo Feliciangeli, Javier GallegoMarta Llanos, Angel Segura, Felip Vilardell, Juan Carlos Percovich, Enrique Grande, Jaume Capdevila, Juan Valle, Rocio Garcia-carbonero

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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.
Original languageEnglish
Article number0
Early online date28 Jan 2021
Publication statusPublished - 28 Jan 2021

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  • Manchester Cancer Research Centre


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