Phase 2 study of cisplatin and everolimus in patients with metastatic extrapulmonary neuroendocrine carcinoma (NEC)

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Introduction: Extrapulmonary NEC (EP-NEC) are an aggressive subgroup of neuroendocrine neoplasms (NEN). Advanced EP-NEC are generally treated with platinum-based cytotoxic regimens. Although highly responsive to cytotoxic therapies, recurrence occurs frequently and rapidly, with a poor prognosis and lack of further treatment options. Genetic alterations in the mTOR pathway have been identified in NEN, providing a rationale for treatment with the mTOR inhibitor everolimus.

Aim(s): In this study, we investigated efficacy and safety of cisplatin in combination with everolimus in patients with advanced EP-NEC.

Materials and methods: In this prospective, phase 2, open-label, national multicenter study, chemotherapy naïve patients with metastatic EP-NEC received cisplatin 75mg/m2 every 3 weeks in combination with daily everolimus 7.5 mg for a maximum of 6 cycles, followed by maintenance everolimus until progression. Response evaluation was performed at 9-weekly intervals and documented according to RECIST 1.1. Toxicity was evaluated according to CTCAE version 5.0.

Conference: 18th Annual ENETS Concerence (2021)

Presenting Author: Levy S

Authors: Levy S, Verbeek W, Eskens F, de Groot D, Van Leerdam M,

Keywords: phase 2, extrapulmonary NEC, everolimus, cisplatin,