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

• 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).

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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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