- Autori:
-
Capdevila, J; Tafuto, S; Krogh, M; Teulé, A; Garcia-Carbonero, R; Klümpen, H-J; Cremer, B; Sevilla, I; Eriksson, B; Tabaksblat, E; Metges, J-P; Reed, N S; Schrader, J; Navarro, V; Valentí, V; Hernando, J; Colao, A M; Vestermark, L; Carnaghi, C; Knigge, U P; Jimenez-Fonseca, P; Benavent, M; de Vos-Geelen, J; Venerito, M; Von Werder, A; Jann, H; Rinke, A; Smith, D; Hörsch, D; Starling, N; Ruszniewski, P; Baudin, E; Caroli-Bosc, F-X; Manzano, J L; Martín, M; Scarpa, A; Lawlor, R T; Ragulan, C; Ps, H; Sadanandam, A; Carmona-Bayonas, A; Salazar, R
- Titolo:
-
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
- Anno:
-
2025
- Tipologia prodotto:
-
Articolo in Rivista
- Tipologia ANVUR:
- Articolo su rivista
- Lingua:
-
Inglese
- Formato:
-
Elettronico
- Referee:
-
No
- Nome rivista:
- ESMO OPEN
- ISSN Rivista:
- 2059-7029
- N° Volume:
-
10
- Numero o Fascicolo:
-
12
- Intervallo pagine:
-
1-11
- Parole chiave:
-
5-fluorouracil; advanced pancreatic neuroendocrine neoplasm; everolimus; panNET; sequential strategy; streptozotocin
- Breve descrizione dei contenuti:
- 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.
- Id prodotto:
-
148751
- Handle IRIS:
-
11562/1177071
- ultima modifica:
-
20 dicembre 2025
- Citazione bibliografica:
-
Capdevila, J; Tafuto, S; Krogh, M; Teulé, A; Garcia-Carbonero, R; Klümpen, H-J; Cremer, B; Sevilla, I; Eriksson, B; Tabaksblat, E; Metges, J-P; Reed, N S; Schrader, J; Navarro, V; Valentí, V; Hernando, J; Colao, A M; Vestermark, L; Carnaghi, C; Knigge, U P; Jimenez-Fonseca, P; Benavent, M; de Vos-Geelen, J; Venerito, M; Von Werder, A; Jann, H; Rinke, A; Smith, D; Hörsch, D; Starling, N; Ruszniewski, P; Baudin, E; Caroli-Bosc, F-X; Manzano, J L; Martín, M; Scarpa, A; Lawlor, R T; Ragulan, C; Ps, H; Sadanandam, A; Carmona-Bayonas, A; Salazar, R,
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
«ESMO OPEN»
, vol.
10
, n.
12
,
2025
,
pp. 1-11
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