Long-term Regorafenib Remission in mCRC May Be Linked to ECOG Score, Less Advanced Disease

Long-term Regorafenib Remission in mCRC May Be Linked to ECOG Score, Less Advanced Disease

Patients with metastatic colorectal cancer (mCRC) who had certain clinical characteristics were more likely to experience long-term remission with regorafenib (Stivarga), as demonstrated by real-world data presented at the 2024 ASCO Gastrointestinal Cancers Symposium.

Specifically, patients with long-term responses had favorable Eastern Cooperative Oncology Group (ECOG) performance status at regorafenib initiation; less advanced disease at the time of diagnosis; and many were also recipients of prior bevacizumab (Avastin).

“This real-world study, performed in the USA and outside of a controlled clinical trial setting, aimed to determine the proportion of patients who had a long-term response to regorafenib,” the authors said in their poster presentation.

The study analyzed data from 2,326 patients who started regorafenib monotherapy between July 1, 2013, and December 31, 2022. A total of 346 patients (15%; median age, 65 years) had a long-term remission of 5 or more months, with 503 patients (22%; median age 65 years) having a long-term remission of 4 months or longer.

Among the cohort of patients with a remission lasting 5 months or longer, less than half (46%; n=160) had stage IV disease at the time of diagnosis. The majority (68%; n=237) had an ECOG performance status of 0-1, and/or received prior bevacizumab (64%; n=221). Of patients who were tested at index, the median carcinoembryonic antigen (CEA) level was 35 ng/mL (range, 9-139). Slightly more than half (51%) had a KRAS mutation, and 5% had a BRAF mutation at index.

The median time from CRC diagnosis to index date was 39.2 months (range, 25.1-64.1), and 33% and 23% received regorafenib as a third-line or fourth-line treatment, respectively. Median time to regorafenib discontinuation was 7.3 months (95% CI, 6.9-7.8).

Findings showed that patient characteristics were similar among patients who had remissions lasting 4 months or longer, with 48% (n=241) having stage IV at diagnosis, 66% (n=332) having an ECOG performance status of 0-1; 68% (n=341) having prior bevacizumab; median CEA level of 40 (range, 9-152); 54% and 6% harboring KRAS and BRAF mutations, respectively.

Median time from diagnosis to index was 38.6 months (range, 24.8-62.8), with 34% and 23%, respectively, receiving regorafenib as a third-line or fourth-line therapy. The median time to treatment discontinuation was 6.0 months (95% CI, 5.-6.2).

Among patients who started regorafenib therapy before the year 2019, (n=1,070), 14% had a remission lasting 5 or more months, while 21% had a remission lasting 4 months or longer. In patients who started the therapy 2019 or later, (n=1,256), 16% and 22% had remissions lasting 5 months and 4 months or longer, respectively.

“These results increase our understanding of patient profiles and factors that influence the effectiveness of regorafenib in real-world clinical practice,” the poster read.

Reference

Kim RD, Pan X, Ostojic H, et. al. Real-world (RW) study in patients (pts) with metastatic colorectal cancer (mCRC) with long-term responses to regorafenib in the USA. J Clin Oncol 42, 2024 (suppl 3; abstr 48). 10.1200/JCO.2024.42.3_suppl.48