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Case Study Suggests Regorafenib Remains Effective Beyond Progression for mCRC

John Otrompke
Published: Tuesday, Apr 05, 2016

Tara E. Seery, MD

Tara E. Seery, MD

Many patients with metastatic colorectal cancer (CRC) will ultimately progress on standard first- and second-line therapy while maintaining a good performance status, placing importance on the optimal use of third-line treatments.

In September 2012, the multikinase inhibitor regorafenib (Stivarga) gained FDA approval for patients with advanced CRC, providing a much-needed third-line option. Since its approval, researchers have explored approaches for managing adverse events (AEs) while optimizing efficacy. Additionally, another therapy, TAS-102 (Lonsurf), has gained approval as a treatment for patients following regorafenib.

To help characterize treatment with regorafenib, researchers from the University of California (UC) at Irvine published a case study in the journal of Cancer Management and Research. This review focused on a 73-year-old Indian woman with a past history of hypertension who achieved stable disease for over 11 months and continued treatment with regorafenib beyond progression.

In the case scenario, the woman was diagnosed in September 2010 with stage 3B KRAS wild-type CRC; however, rather than receiving upfront chemotherapy she decided to move back to India. The patient presented again in March 2011, and began treatment with capecitabine, oxaliplatin, and bevacizumab. In early 2012, she was restaged and found to have diffuse metastatic disease. Second-line cetuximab and FOLFIRI was administered from February 2012 to August 2013.

After progression on first- and second-line therapy, the patient was started on regorafenib as a third-line option in September 2013. Initially, due to problems with hypertension and fatigue, treatment was held for 2 weeks, and the dose was adjusted. After resolution of AEs, an 80 mg/day dose of regorafenib was selected, which is half the FDA-approved dose.

In August 2014, after nearly a year on regorafenib, a PET/ CT scan indicated that the patient’s cancer had progressed; however, after discussing with the patient, regorafenib was continued at 80 mg/day, due to a lack of AEs and the patient’s comfort level with the medication.

In August 2015, the patient remained on regorafenib, with continued progression and a consistent performance status of 1. At this point, the patient did not mention any AEs and felt as though she had an improved quality of life. Later that year, she was moved to hospice care.

To gain more insight into this unique case, OncLive spoke with the senior author Tara E. Seery, MD, assistant professor at UC Irvine.

OncLive: What sets this apart as a unique case study?

Seery: With most cancers, when someone progresses on a drug, you take him or her off it. In this case, however, even though the patient has progressed, the rate they’re progressing at is much slower than if they were on no drug at all.

At the time, there really was nothing else, because Lonsurf was not approved yet. The patient was really feeling good, so we came to an agreement and continued regorafenib, because it was really helping her quality of life.

We’re one of the first teams of researchers to talk about using it after progression, but using it at a reduced dose is more common.

In your case report, did regorafenib extend the patient’s life, and reduce the symptoms of her disease?

Oh, completely. It’s exciting, because we’re trying to make colon cancer more of a chronic disease. We’re doing more surgery, therapies on all the metastases, and we’re just being more aggressive on the whole. Survival is getting longer and longer. In the past, they used to say, "You have 24 to 26 months," but now a lot of us are seeing patients living a whole lot longer. But there’s still a whole lot of room to grow.


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