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Regorafenib: A Review of Its Use in Previously Treated Patients with Progressive Metastatic Colorectal Cancer

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Abstract

Regorafenib (Stivarga®) is an inhibitor of multiple protein kinases, including those involved in oncogenesis, tumour angiogenesis and maintenance of the tumour microenvironment. The drug is approved as monotherapy for the treatment of metastatic colorectal cancer (mCRC) in patients who have previously received all standard systemic anticancer treatments (US, EU and Canada) or in patients with unresectable, advanced or recurrent colorectal cancer (Japan). In the randomized, controlled COloRectal cancer treated with REgorafenib or plaCebo after failure of standard Therapy (CORRECT) trial, regorafenib 160 mg once daily for the first 3 weeks of each 4-week cycle plus best supportive care (BSC) was associated with a significantly longer median overall survival than placebo plus BSC in patients with previously treated, progressive mCRC. The drug was also associated with significantly longer progression-free survival and better disease control rates than placebo, although objective response rates were similar in both treatment groups. Regorafenib did not appear to compromise health-related quality of life over the study duration and had a generally acceptable tolerability profile. The introduction of regorafenib expands the currently limited range of effective treatment options in patients with previously treated, progressive mCRC.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Natalie J. Carter

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  1. Natalie J. Carter
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Correspondence to Natalie J. Carter.

Additional information

The manuscript was reviewed by: A. B. Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA; Y. Sunakawa, Division of Medical Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.

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Carter, N.J. Regorafenib: A Review of Its Use in Previously Treated Patients with Progressive Metastatic Colorectal Cancer. Drugs Aging 31, 67–78 (2014). https://doi.org/10.1007/s40266-013-0140-6

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