Multicenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome.

ABSTRACT:

Purpose

We examined cabazitaxel, a novel next-generation taxoid, in patients with metastatic gastric cancer in a multicenter phase II study.

Patients and methods

Patients who have progressed on one or more prior therapies for locally advanced, unresectable, or metastatic disease were eligible, and prior taxane therapy was allowed. Taxane-naïve and pretreated cohorts were analyzed independently for efficacy. The primary endpoint for both cohorts was progression-free survival (PFS) using RECIST 1.1, using a Simon's two-stage design (10% significance and 80% power) for both cohorts. Comprehensive molecular annotation included whole exome and bulk RNA sequencing.

Results

Fifty-three patients enrolled in the taxane-naïve cohort (Arm A) and 23 patients in the prior-taxane c

SUBMITTER: Shah MA 

PROVIDER: S-EPMC8209413 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature