An Italian multicenter phase II trial of Metronomic Temozolomide in unfit patients with advanced neuroendocrine neoplasms: MeTe study

#4029

Introduction: Metronomic schedule of temozolomide (mTEM) can overcome resistance induced by O6-methylguanine-DNA-methyltransferase (MGMT) and reduce toxicities being particularly suitable for unfit patients (pts). We present the first data from a non-planned interim analysis of this phase II Italian single arm multicenter study.

Aim(s): To evaluate activity and safety of mTEM in unfit pts with low-grade advanced NENs.

Materials and methods: Eligible pts has advanced, progressive, GEP or bronchial, or unknown primary, functioning/not-functioning (NF) NETs, with at least one of the following frailty criteria: ECOG performance status (PS) 2, organ failure, severe comorbidities, 3 or more prior systemic antitumor therapies. Temozolomide 60 mg was administered once daily (28-day cycles) until disease progression. The primary endpoint is the progression-free-survival (PFS). The secondary endpoints are the overall survival (OS), overall response rate (ORR), duration of response, safety, and QoL. Explorative analyses will evaluate the MGMT status in tumor tissue to correlate with clinical outcomes.

Conference:

Presenting Author: Spada F

Authors: Spada F, Jemos C, Pisa E, Bagnardi V, Frassoni S,

Keywords: Temozolomide, Metronomic, Chemotherapy, Frailty, MGMT, NEN, NET, QoL,