A phase II single arm trial evaluating the efficacy and safety of Temozolomide for second-line treatment of neuroendocrine carcinomas progressing after first-line platinum-based therapy

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Introduction: Second-line treatment for neuroendocrine carcinoma (NEC) have been investigated in prospective trials, with only few prospective trials ongoing. Therefore, there is no consensus on the second-line regimen to use in patients with progressive NEC. These patients have generally a poor performance status (PS) and the tolerance to combination therapy is low. Metronomic temozolomide showed, in retrospective trials, a good safety and efficacy profile.

Aim(s): The aim of this study is to establish a possible second line of treatment in NEC.

Materials and methods: We conducted a single-arm, phase II study of patients with NEC who were progressed after first-line platinum-based chemotherapy. Patients were treated with Temozolomide 100 mg/m2/day by mouth seven days followed by seven days of stop (regimen one week on / one week off). The primary end point was overall response rate (ORR), and secondary end points were median progression-free survival (mPFS), median overall survival (mOS), safety and tolerability.

Conference:

Presenting Author:

Authors: Cannella L, von Arx C, Bracigliano A, Pizzolorusso A, Antonella D,

Keywords: neuroendocrine, temozolomide, NEC, Treatment,