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Phase II study of e...
Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms.
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- Morken, Siren (författare)
- Haukeland University Hospital
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- Langer, Seppo W (författare)
- Copenhagen University Hospital,University of Copenhagen
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- Sundlöv, Anna (författare)
- Lund University,Lunds universitet,Medicinsk onkologi,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Medical oncology,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Vestermark, Lene Weber (författare)
- Odense University Hospital
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- Ladekarl, Morten (författare)
- Aarhus University Hospital,Aalborg University
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- Hjortland, Geir Olav (författare)
- Oslo university hospital
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- Svensson, Johanna (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Sahlgrenska University Hospital
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- Tabaksblat, Elizaveta Mitkina (författare)
- Aarhus University Hospital
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- Haslerud, Torjan Magne (författare)
- Haukeland University Hospital
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- Assmus, Jörg (författare)
- Haukeland University Hospital
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- Detlefsen, Sönke (författare)
- University of Southern Denmark,Odense University Hospital
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- Couvelard, Anne (författare)
- Hopital Bichat-Claude-Bernard AP-HP
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- Perren, Aurel (författare)
- University of Bern
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- Sorbye, Halfdan (författare)
- Haukeland University Hospital,University of Bergen
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(creator_code:org_t)
- 2023
- 2023
- Engelska.
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Ingår i: British journal of cancer. - 0007-0920 .- 1532-1827. ; 129:12, s. 1930-1939
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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Abstract
Ämnesord
Stäng
- 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 andsafety of everolimus and temozolomide as first-line treatment for these patients.Patients received everolimus 10mg daily continuously and temozolomide 150mg/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.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) 10.2months and the median overall survival (OS) 26.4months. Considering 26 NET G3 patients, 6months DCR was 77% vs. 22% among nine NEC patients (p=0.006). PFS was superior for NET G3 vs. NEC (12.6months vs. 3.4months, Log-rank-test: p=0.133, Breslow-test: p<0.001). OS was significantly better for NET G3 (31.4months vs. 7.8months, p=0.003). Grade 3 and 4 toxicities were reported in 43% and 38%. QoL remained stable during treatment.Everolimus and temozolomide may be a treatment option for selected GEP-NET G3 patients including careful monitoring. Toxicity did not compromise QoL.ClinicalTrials.gov (NTC02248012).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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- art (ämneskategori)
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Morken, Siren
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Langer, Seppo W
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Sundlöv, Anna
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Vestermark, Lene ...
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Ladekarl, Morten
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Hjortland, Geir ...
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Svensson, Johann ...
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Tabaksblat, Eliz ...
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Haslerud, Torjan ...
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Assmus, Jörg
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Detlefsen, Sönke
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Couvelard, Anne
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Perren, Aurel
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Sorbye, Halfdan
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