Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms
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Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms. / 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.
I: British Journal of Cancer, Bind 129, 2023, s. 1930–1939.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms
AU - Morken, Siren
AU - Langer, Seppo W
AU - Sundlöv, Anna
AU - Vestermark, Lene Weber
AU - Ladekarl, Morten
AU - Hjortland, Geir Olav
AU - Svensson, Johanna B
AU - Tabaksblat, Elizaveta Mitkina
AU - Haslerud, Torjan Magne
AU - Assmus, Jörg
AU - Detlefsen, Sönke
AU - Couvelard, Anne
AU - Perren, Aurel
AU - Sorbye, Halfdan
N1 - © 2023. The Author(s).
PY - 2023
Y1 - 2023
N2 - 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/m 2 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).
AB - 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/m 2 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).
U2 - 10.1038/s41416-023-02462-0
DO - 10.1038/s41416-023-02462-0
M3 - Journal article
C2 - 37872405
VL - 129
SP - 1930
EP - 1939
JO - The British journal of cancer. Supplement
JF - The British journal of cancer. Supplement
SN - 0007-0920
ER -
ID: 371383662