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01-12-2020 | Acute Myeloid Leukemia | Original Research Article

Sunitinib in Patients with Metastatic Colorectal Cancer (mCRC) with FLT-3 Amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Authors: Tareq Al Baghdadi, Elizabeth Garrett-Mayer, Susan Halabi, Pam K. Mangat, Patricia Rich, Eugene R. Ahn, Seungjean Chai, Andrew L. Rygiel, Olufunlayo Osayameh, Kaitlyn R. Antonelli, Samiha Islam, Suanna S. Bruinooge, Richard L. Schilsky

Published in: Targeted Oncology | Issue 6/2020

Abstract

Background

TAPUR is a pragmatic, phase II basket study evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Sunitinib is an oral multikinase inhibitor of FMS-like tyrosine kinase-3 (FLT-3), among other targets. Results from a cohort of patients with metastatic colorectal cancer (mCRC) with FLT-3 amplification treated with sunitinib are reported.

Objective

This study aimed to investigate whether patients with mCRC with FLT-3 amplification would be responsive to sunitinib, an oral multikinase inhibitor.

Methods

Eligible patients received a standard sunitinib dose of 50 mg orally for 4 weeks followed by 2 weeks off. Simon’s two-stage design was used with the primary study endpoint of objective response (OR) or stable disease (SD) at 16 weeks based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints were progression-free survival, overall survival, and safety.

Results

Ten patients were enrolled from November 2016 to April 2018. All patients had mCRC with FLT-3 amplification. No ORs were observed. Although two patients had SD at 16 weeks, one died because of disease progression shortly thereafter and the cohort was closed. A single grade 3 adverse event of diarrhea was reported as possibly related to sunitinib.

Conclusions

Monotherapy with sunitinib does not have clinical activity in patients with mCRC with FLT-3 amplification and should not be prescribed for off-label use. Other treatments should be considered for these patients, including treatments offered in clinical trials.

Clinical Trial registration

NCT02693535 (26 February 2016).

Available only for authorised users

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Title: Sunitinib in Patients with Metastatic Colorectal Cancer (mCRC) with FLT-3 Amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Authors: Tareq Al Baghdadi
Elizabeth Garrett-Mayer
Susan Halabi
Pam K. Mangat
Patricia Rich
Eugene R. Ahn
Seungjean Chai
Andrew L. Rygiel
Olufunlayo Osayameh
Kaitlyn R. Antonelli
Samiha Islam
Suanna S. Bruinooge
Richard L. Schilsky
Publication date: 01-12-2020
Publisher: Springer International Publishing
Keywords: Acute Myeloid Leukemia
Sunitinib
Colorectal Cancer
Colorectal Cancer
Published in: Targeted Oncology / Issue 6/2020
Print ISSN: 1776-2596
Electronic ISSN: 1776-260X
DOI: https://doi.org/10.1007/s11523-020-00752-8

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