Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study.

ABSTRACT:

Background

Preclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase.

Methods

This phase II trial included patients with progressive advanced DDLPS. They received Aplidin 5 mg/m(2) days 1-15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy.

Results

Between August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two we

SUBMITTER: Toulmonde M 

PROVIDER: S-EPMC4478976 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature