Metastatic colorectal cancer responsive to regorafenib for 2 years: a case report

Abstract

BackgroundRegorafenib is an oral multikinase inhibitor that has been demonstrated as clinically effective in patients with metastatic colorectal cancer in phase III studies. Although disease control was achieved in 40% of the pretreated patients with metastatic colorectal cancer in the pivotal studies, radiological response has rarely been reported. Severe adverse events associated with regorafenib are known to occur during the first and second courses of treatment. We present a case of a 62-year-old Japanese patient whose metastatic colorectal cancer has been responding to treatment with regorafenib for 2 years.Case presentationA 54-year-old Japanese man visited our institute exhibiting general malaise, and he was diagnosed with ascending colon cancer in April 2006. He underwent right hemicolectomy, and the final staging was T3N0M0, stage II. After 19 months, pulmonary metastasis and anastomotic recurrences were detected, and a series of operations were performed to resect both metastatic lesions. After that, liver metastasis, a duodenal metastasis with right renal invasion, right adrenal metastasis, and para-aortic lymph node metastases were observed during follow-up, and chemotherapy and resection were performed. The patient had metastatic para-aortic lymph nodes after the fifth tumor resection and underwent multiple lines of chemotherapy in April 2014. Regorafenib monotherapy was started at 80 mg/day. Then, regorafenib was increased to 120 mg/day in the second cycle. Regorafenib monotherapy led to 60% tumor shrinkage within the initial 2 months, and the tumor further decreased in size over 4 months until it became unrecognizable on imaging studies. The clinical effects of regorafenib monotherapy have shown a partial response according to Response Evaluation Criteria in Solid Tumors criteria. No severe adverse events were observed, except for mild fatigue and hand-foot syndrome. The patient has received 24 courses of regorafenib over 2 years without exhibiting tumor progression.ConclusionsTo the best of our knowledge, this is the longest treatment with regorafenib without tumor progression ever reported. A reduced dosage of regorafenib at induction may ameliorate the cutaneous and hepatic toxicity associated with its use.

Complete response of MSI‑high metastatic colon cancer following treatment with regorafenib: A case report

“…However, the CORRECT and CONCUR trials showed that both the PFS and OS of mCRC patients were prolonged following regorafenib treatment, compared with the placebo groups (P<0.0001 and P=0.0016), with a high disease control rate of up to 51% ( 2 , 3 ). Unfortunately, no patients in either study showed a CR, and only a few previously reported cases indicated radiological responses ( 4 , 7 ). More recent studies of regorafenib have reported similar results, with no patients showing a CR and only a few showing a PR (0-3%) ( 8 , 9 ).…”

“…As suggested by Yoshino et al ( 4 ), we stopped regorafenib treatment after the 17th cycle due to the lack of remnant tumor evident on both CT and PET-CT. Remarkably, the patient has not experienced recurrence 2 years since treatment cessation; no similar findings have been reported previously.…”

“…Although disease control [partial response (PR) plus stable disease] was achieved in 51% of the patients, only 4% showed a PR, and none showed a complete response (CR). Yoshino et al ( 4 ) recently reported a case of mCRC that responded well to regorafenib, resulting in a 2-year-long therapy with a PR. Here, we report the very first case of mCRC that was refractory to conventional chemotherapy such as fluorouracil, leucovorin and irinotecan (FOLFIRI) with cetuximab and fluorouracil, leucovorin and oxaliplatin (FOLFOX) with bevacizumab, but showed a CR to regorafenib.…”

Regorafenib – Five Years in Review

“…It is advocated that treatment continues until disease progression or unacceptable toxicity levels have been reached, which in some cases, as demonstrated in a recent Japanese case-report, may take several years. 36 Subsequently, approval was granted for management of GIST. Also, approval is almost prohibitively narrow, as it comprises a tumour that is either locally advanced, unresectable or metastatic after treatment with imatinib and sunitinib.…”

“…Also, approval is almost prohibitively narrow, as it comprises a tumour that is either locally advanced, unresectable or metastatic after treatment with imatinib and sunitinib. 36,37 Most recently, attention has been drawn to HCC. Similarly, to the two prior approvals, in this case, the scope of the drug is for patients who are candidates for systemic treatment as a second-line treatment after failure or intolerance for sorafenib.…”