Streptozotocin plus 5-fluorouracil followed by everolimus or the reverse sequence in patients with advanced pancreatic neuroendocrine tumors (SEQTOR-GETNE phase III study): a randomized clinical trial

Background: Everolimus or streptozotocin plus 5-fluorouracil (STZ/5-FU) are approved treatments for patients with pancreatic neuroendocrine tumors (panNETs). The SEQTOR trial aimed to assess the optimal treatment sequence. Patients and methods: SEQTOR was an international, open-label, randomized, cr...

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Autores: De Vos-Geelen, J., Venerito, Marino, Von-Werder, Alezander, Jann, Henning, Rinke, Anja, Smith, D., Hörsch, D., Starling, Naureen, Ruszniewski, Philippe, Baudin, Eric, Metges, J.-P., Caroli-Bosc, F.-X., Reed, N.S., Manzano, José Luis, Schrader, J., Martín, M., Navarro Perez, Valentin, Scarpa, A., Valentí, Víctor, Lawlor, R.T., Hernando, Jorge, Ragulan, C., Colao, A.M., Ps, H., Vestermark, Lene, Sadanandam, A., Carnaghi, Carlo, Knigge, U.P., Capdevila, Jaume, Tafuto, Salvatore, Krogh, M., Teulé-Vega, Àlex, Garcia Carbonero, Rocio, Klümpen, H.-J., Cremer, B., Sevilla, I., Eriksson, B., Tabaksblat, E., Carmona Bayonas, Alberto, Salazar Soler, Ramón, Jiménez Fonseca, Paula, Benavent Viñuales, Marta
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/227020
Acceso en línea:https://hdl.handle.net/2445/227020
Access Level:acceso abierto
Palabra clave:Estreptomicina
Streptomycin
Descripción
Sumario:Background: Everolimus or streptozotocin plus 5-fluorouracil (STZ/5-FU) are approved treatments for patients with pancreatic neuroendocrine tumors (panNETs). The SEQTOR trial aimed to assess the optimal treatment sequence. Patients and methods: SEQTOR was an international, open-label, randomized, crossover, phase III trial that recruited adults with unresectable or metastatic, advanced, well-differentiated panNET. Patients received 10 mg/day of everolimus followed upon progression by STZ/5-FU; or the reverse sequence. The primary endpoint was the 35-month progression-free survival (PFS) rate after first- and second-line treatment; however, due to slow accrual and longer survival, it was changed to the 12-month PFS rate following first-line treatment (12-mPFS1). Results: Patients were randomized to everolimus (n = 72) or STZ/5-FU (n = 69) first. The 12-mPFS1 was 71.4% [95% confidence interval (CI) 59.4% to 81.6%] and 61.8% (95% CI 49.2% to 73.3%) (odds ratio 0.65, 95% CI 0.32-1.32) with a median PFS1 of 19.4 versus 22.7 months for everolimus and STZ/5-FU, respectively. STZ/5-FU achieved a significantly higher overall response rate in first-line (11.6% versus 30.3%, P = 0.012) and second-line (30.6% versus 9.1%, P = 0.072) treatments. No differences were shown in overall survival (median 61.7 versus 50.6 months in everolimus first and STZ/5-FU first, respectively; hazard ratio 1.43, 95% CI 0.86-2.37). Discontinuations of everolimus were more frequent. Conclusion: STZ/5-FU and everolimus were not statistically different in PFS rates, but STZ/5-FU achieved higher response rates. Keywords: 5-fluorouracil; advanced pancreatic neuroendocrine neoplasm; everolimus; panNET; sequential strategy; streptozotocin.

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