Regorafenib as Salvage Treatment in Korean Patients with Refractory Metastatic Colorectal Cancer.

Abstract

PURPOSE:

Regorafenib, an oral multi-targeted tyrosine kinase inhibitor, is considered the new standard of care in patients with chemotherapy-refractory colorectal cancers (CRCs). However, there are no data on this drug in Korean patients.

MATERIALS AND METHODS:

We evaluated patients who received oral regorafenib 160 mg once daily during the first 3 weeks of each 4-week cycle between August 2013 and September 2013. All patients had previously progressed fluorouracil, irinotecan, and oxaliplatin with or without biologic agents such as cetuximab or bevacizumab.

RESULTS:

Thirty-two patients were enrolled (median age, 57 years; male:female ratio, 20:12; Eastern Cooperative Oncology Group performance status [0-1:2], 31:1; colon:rectum, 21:11). The overall response rate was 3.1% and the disease control rate was 50.0% (95% confidence interval [CI]) with one partial response and 15 patients with stable disease. The median progression-free survival was 4.2 months (95% CI, 3.1 to 5.2 months) and the median overall survival has not yet been reached. The most common adverse events of grade two or higher related to regorafenib were hand-foot skin reaction (25%), mucositis (19%), abdominal pain (9%), and liver function test (LFT) abnormalities (9%). Grade 3 or 4 toxicities included LFT abnormalities (9%), abdominal pain (9%), rash (6%), anemia (3%), leukopenia (3%), neutropenic fever (3%), and fatigue (3%). There was no treatment-related death.

CONCLUSION:

Regorafenib appears to have promising activity and tolerable toxicity profiles in Korean patients with refractory CRC, consistent with the CORRECT trial findings.

• Authors: Seung Tae Kim, Tae Won Kim, Kyu-pyo Kim, Tae-You Kim, Sae-Won Han, Ji Yun Lee, Sung Hee Lim, Min-Young Lee, Haesu Kim, Young Suk Park
• Journal: Cancer research and treatment (Cancer Res Treat) Vol. 47 Issue 4 Pg. 790-5 (Oct 2015) ISSN: 2005-9256 [Electronic] Korea (South)
• PMID: 25672574 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Phenylurea Compounds
• Pyridines
• regorafenib

Topics

• Adult
• Aged
• Antineoplastic Agents (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Asian People
• Colorectal Neoplasms (drug therapy, epidemiology)
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Phenylurea Compounds (adverse effects, therapeutic use)
• Pyridines (adverse effects, therapeutic use)
• Republic of Korea (epidemiology)
• Salvage Therapy