Phase II study of everolimus and temozolomide as 1-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms (NET G3 and NEC)

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Introduction: High-grade gastroenteropancreatic neuroendocrine neoplasms (HG GEP-NEN) consist of poorly differentiated neuroendocrine carcinoma (NEC) and well-differentiated neuroendocrine tumors (NET G3). Platinum/etoposide has been the cornerstone of treatment in advanced cases, but show limited benefit for patients when tumors have Ki-67 ≤55%.

Aim(s): To evaluate everolimus/temozolomide as first-line treatment for advanced HG GEP-NEN with Ki-67 ≤55%.

Materials and methods: In a prospective non-randomized multicentre study, patients with advanced HG GEP-NEN were given everolimus 10 mg daily combined with temozolomide 150 mg/m2 for 7 days every two weeks. Study endpoints were disease control rate (DCR), response rate, survival, safety and quality of life (QoL). Histopathological re-evaluation was performed in accordance to the new 2019 WHO NEN classification.

Conference:

Presenting Author:

Authors: Morken S, Langer S, Sundlöv A, Detlefsen S, Krogh M,

Keywords: neuroendocrine neoplasm, neuroendocrine carcinoma, high-grade gastroenteropancreatic, everolimus, temozolomide,