Randomized study of etirinotecan pegol versus irinotecan as second-line treatment for metastatic colorectal cancer.

ABSTRACT:

Purpose

Etirinotecan pegol (EP) is a long-acting topoisomerase-I inhibitor designed to provide sustained exposure to SN-38 (active metabolite of irinotecan). This phase II study compared EP versus irinotecan as second-line treatment for KRAS-mutant, irinotecan-naïve, metastatic colorectal cancer (mCRC).

Methods

Patients were randomized to EP 145 mg/m² or irinotecan 350 mg/m² Q21d until disease progression/unacceptable toxicity. The primary endpoint was progression-free survival (PFS) with response determined by central radiologic review (RECIST version 1.1).

Results

The study was terminated before completing accrual due to evolving standards of care. Eighty-three patients were randomized. Median PFS was longer with EP versus irinotecan (4.0 versu

SUBMITTER: Lenz HJ 

PROVIDER: S-EPMC6863159 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature