Sunitinib in Patients with Metastatic Colorectal Cancer (mCRC) with FLT - 3 Amplification: Results from the Targeted Age
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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 Tareq Al Baghdadi1 · Elizabeth Garrett‑Mayer2 · Susan Halabi3 · Pam K. Mangat2 · Patricia Rich4 · Eugene R. Ahn5 · Seungjean Chai6 · Andrew L. Rygiel2 · Olufunlayo Osayameh2 · Kaitlyn R. Antonelli2 · Samiha Islam2 · Suanna S. Bruinooge2 · Richard L. Schilsky2
© Springer Nature Switzerland AG 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).
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11523-020-00752-8) contains supplementary material, which is available to authorized users. * Pam K. Mangat [email protected] 1
Michigan Cancer Research Consortium, Ypsilanti, MI, USA
2
American Society of Clinical Oncology, 2318 Mill Road, Alexandria, VA 22314, USA
3
Duke University Medical Center, Durham, NC, USA
4
Cancer Treatment Centers of America, Atlanta, GA, USA
5
Cancer Treatment Centers of America Chicago, Chicago, IL, USA
6
Levine Cancer Institute, Atrium Health, Charlotte, NC, USA
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T. Al Baghdadi et al.
Key Points Comprehensive genomic profiling of advanced cancers may lead to new options for targeted treatment with currently available drugs. Sunitinib, an oral multikinase
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