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Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms.

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Τίτλος: Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms.
Συγγραφείς: Morken S; Department of Oncology, Haukeland University Hospital, Bergen, Norway. siren.morken@helse-bergen.no., Langer SW; Department of Oncology, Rigshospitalet, Copenhagen, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Sundlöv A; Division of Oncology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden., Vestermark LW; Department of Oncology, Odense University Hospital, Odense, Denmark., Ladekarl M; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.; Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark.; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark., Hjortland GO; Department of Oncology, Oslo University Hospital, Oslo, Norway., Svensson JB; Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden., Tabaksblat EM; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark., Haslerud TM; Department of Radiology and Nuclear Medicine, Haukeland University Hospital, Bergen, Norway., Assmus J; Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway., Detlefsen S; Department of Pathology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Couvelard A; Department of Pathology, Bichat Hospital, Paris, France., Perren A; Institute of Tissue medicine and Pathology, University of Bern, Bern, Switzerland., Sorbye H; Department of Oncology, Haukeland University Hospital, Bergen, Norway.; Department of Clinical Science, University of Bergen, Bergen, Norway.
Πηγή: British journal of cancer [Br J Cancer] 2023 Dec; Vol. 129 (12), pp. 1930-1939. Date of Electronic Publication: 2023 Oct 23.
Τύπος έκδοσης: Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Nature Publishing Group on behalf of Cancer Research UK Country of Publication: England NLM ID: 0370635 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1827 (Electronic) Linking ISSN: 00070920 NLM ISO Abbreviation: Br J Cancer Subsets: MEDLINE
Imprint Name(s): Publication: 2002- : London : Nature Publishing Group on behalf of Cancer Research UK
Original Publication: London, Lewis.
Ιατρικοί όροι (MeSH): Neuroendocrine Tumors*/pathology , Pancreatic Neoplasms*/pathology, Everolimus/adverse effects ; Humans ; Temozolomide ; Quality of Life ; Prospective Studies
Περίληψη: Background: The optimal treatment for metastatic high-grade gastroenteropancreatic (GEP) neuroendocrine neoplasms when Ki-67 ≤55% is unknown. A prospective multi-centre phase 2 study was performed to evaluate the efficacy and safety of everolimus and temozolomide as first-line treatment for these patients.
Methods: Patients received everolimus 10 mg daily continuously and temozolomide 150 mg/m2 for 7 days every 2 weeks. Endpoints included response, survival, safety and quality of life (QoL). Histopathological re-evaluation according to the 2019 WHO classification was performed.
Results: For 37 eligible patients, the primary endpoint with 65% disease control rate (DCR) at 6 months (m) was reached. The response rate was 30%, the median progression-free survival (PFS) 10.2 months and the median overall survival (OS) 26.4 months. Considering 26 NET G3 patients, 6 months DCR was 77% vs. 22% among nine NEC patients (p = 0.006). PFS was superior for NET G3 vs. NEC (12.6 months vs. 3.4 months, Log-rank-test: p = 0.133, Breslow-test: p < 0.001). OS was significantly better for NET G3 (31.4 months vs. 7.8 months, p = 0.003). Grade 3 and 4 toxicities were reported in 43% and 38%. QoL remained stable during treatment.
Conclusion: Everolimus and temozolomide may be a treatment option for selected GEP-NET G3 patients including careful monitoring. Toxicity did not compromise QoL.
Clinical Trial Registration: ClinicalTrials.gov (NTC02248012).
(© 2023. The Author(s).)
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Substance Nomenclature: 9HW64Q8G6G (Everolimus)
YF1K15M17Y (Temozolomide)
Entry Date(s): Date Created: 20231023 Date Completed: 20231216 Latest Revision: 20240305
Update Code: 20260130
PubMed Central ID: PMC10703888
DOI: 10.1038/s41416-023-02462-0
PMID: 37872405
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1532-1827
DOI:10.1038/s41416-023-02462-0