Morken, Siren; Langer, Seppo W; Sundlöv, Anna; Vestermark, Lene Weber; Ladekarl, Morten; Hjortland, Geir Olav; Svensson, Johanna B; Tabaksblat, Elizaveta Mitkina; Haslerud, Torjan Magne; Assmus, Jörg; Detlefsen, Sönke; Couvelard, Anne; Perren, Aurel; Sorbye, Halfdan (2023). Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms. British journal of cancer, 129(12), pp. 1930-1939. Nature Publishing Group 10.1038/s41416-023-02462-0
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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).
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Service Sector > Institute of Pathology |
UniBE Contributor: |
Perren, Aurel |
Subjects: |
500 Science > 570 Life sciences; biology 600 Technology > 610 Medicine & health |
ISSN: |
0007-0920 |
Publisher: |
Nature Publishing Group |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
24 Oct 2023 10:29 |
Last Modified: |
09 Dec 2023 00:15 |
Publisher DOI: |
10.1038/s41416-023-02462-0 |
PubMed ID: |
37872405 |
BORIS DOI: |
10.48350/187398 |
URI: |
https://boris.unibe.ch/id/eprint/187398 |
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