Dr. Kim Presents Research Findings Investigating the Use of Regorafenib in mCRC
Richard Kim, MD, a senior member of the Gastrointestinal Oncology Program at Moffitt Cancer Center, recently presented at the 2024 Gastrointestinal Cancer Symposium discussing the rationale for launching the data derived from an investigation using regorafenib (Stivarga) and its long-term responses in patients with metastatic colorectal cancer (mCRC).
Researchers found that a positive ECOG performance status, lower baseline lactate dehydrogenase levels and the absence of BRAF and KRAS mutations were among the characteristics linked to a prolonged response to regorafenib in patients with mCRC.
Regorafenib received FDA approval in 2012 for use in the refractory setting for patients with mCRC who did not respond to standard lines of chemotherapy, according to a phase 3 CORRECT trial (NCT01103323).
The real-world analysis examined the effectiveness of regorafenib in patients with mCRC, motivated by case reports of some patients remaining on regorafenib for longer durations than reported in the CORRECT study. Instances include patients receiving regorafenib for six months, eight months, and even up to 24 months, Dr. Kim states.
Additionally, the analysis assessed how well patients responded to regorafenib in a real-world context. Dr. Kim’s data from the Flatiron Health database shares that investigators analyzed information on 849 patients receiving regorafenib and who had long-term responses to the agent, including baseline demographics – age, race, stage at diagnosis and biomarkers. The primary endpoint was to evaluate long-term responders, defined as patients receiving regorafenib for at least four to five months.
Results from the study indicated that 22% of the patients received regorafenib for more than four months and 15% of patients received the agent for over five months. Dr. Kim adds the biomarkers analysis did not reveal any correlation between biomarkers and efficacy results. Like the CORRECT data, this real-world evidence indicates that a specific patient population can effectively receive regorafenib for more than four to five months.
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