Temozolomide as second and subsequent lines of treatment in metastatic adrenocortical cancer: Prospective phase II clinical trial

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Introduction: Adrenocortical carcinoma (ACC) is a rare malignancy with limited treatment options. There are still no effective options for 2nd and subsequent lines of chemotherapy (ChT). Despite promising results of retrospective study with temozolomide (Tem), no prospective studies evaluating Tem efficacy have been published yet.

Aim(s): Here, we investigated efficacy Tem in treatment of metastatic ACC.

Materials and methods: This prospective single center phase II study used a two-stage Simon design. The primary endpoint is objective response rate (ORR). Secondary endpoints – progression-free survival (PFS), overall survival (OS), disease control rate (DCR)≥ 6 months, treatment safety. At first stage, enrollment of 12 patients (pts) was planned (20% included for possible data loss). If an objective response was achieved in at least one of the 10 cases assessed, enrollment will continue to 29 patients.

Conference:

Presenting Author: Zhulikov Y

Authors: Zhulikov Y, Kovalenko E, Bokhyan V, Khoroshilov M, Gabrava M,

Keywords: adrenocortical cancer, temozolomide, mitotane,