dc.contributor.author | Morken, Siren | |
dc.contributor.author | Langer, Seppo W. | |
dc.contributor.author | Sundlöv, Anna | |
dc.contributor.author | Vestermark, Lene Weber | |
dc.contributor.author | Ladekarl, Morten | |
dc.contributor.author | Hjortland, Geir Olav | |
dc.contributor.author | Svensson, Johanna B. | |
dc.contributor.author | Tabaksblat, Elizaveta Mitkina | |
dc.contributor.author | Haslerud, Torjan Magne | |
dc.contributor.author | Assmus, Jörg | |
dc.contributor.author | Detlefsen, Sönke | |
dc.contributor.author | Couvelard, Anne | |
dc.contributor.author | Perren, Aurel | |
dc.contributor.author | Sorbye, Halfdan | |
dc.date.accessioned | 2024-05-13T11:37:40Z | |
dc.date.available | 2024-05-13T11:37:40Z | |
dc.date.created | 2023-11-07T15:23:04Z | |
dc.date.issued | 2023 | |
dc.identifier.issn | 0007-0920 | |
dc.identifier.uri | https://hdl.handle.net/11250/3130125 | |
dc.description.abstract | 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. | en_US |
dc.language.iso | eng | en_US |
dc.publisher | Nature | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms | en_US |
dc.type | Journal article | en_US |
dc.type | Peer reviewed | en_US |
dc.description.version | publishedVersion | en_US |
dc.rights.holder | Copyright 2023 The Author(s) | en_US |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 2 | |
dc.identifier.doi | 10.1038/s41416-023-02462-0 | |
dc.identifier.cristin | 2193433 | |
dc.source.journal | British Journal of Cancer | en_US |
dc.source.pagenumber | 1930-1939 | en_US |
dc.identifier.citation | British Journal of Cancer. 2023, 129, 1930-1939. | en_US |
dc.source.volume | 129 | en_US |