Patients with metastatic colorectal cancer who experienced long-term remissions from treatment with Stivarga (regorafenib) tended to have certain characteristics, according to research presented at the 2024 ASCO Gastrointestinal Cancers Symposium.
“Certain patients with metastatic colorectal cancer continue to benefit from (Stivarga) treatment over long periods of time,” the researchers wrote in their poster presentation.
Specifically, patients with long-term responses had favorable Eastern Cooperative Oncology Group (ECOG) performance status at the start of their Stivarga regimen, indicating that they could perform all or most of their daily tasks independently. Long-term remission was also associated with less advanced disease at the time of diagnosis; and many were also recipients of prior Avastin (bevacizumab).
The study analyzed data from 2,326 patients with metastatic colorectal cancer who started Stivarga between July 1, 2013 and Dec. 31, 2022. A total of 346 patients (15%; median age, 65) had a long-term remission of five or more months, with 503 patients (22%; median age 65) having a long-term remission of four months or longer.
“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 (Stivarga),” the researchers wrote.
Among the cohort of patients with a remission lasting four months or longer, less than half (46%; 160 patients) had stage 4 disease at the time of diagnosis. The majority (68%; 237 patients) had an ECOG performance status of 0 to 1 and/or received prior Avastin (64%; 221 patients). Of patients who were tested at index, the median carcinoembryonic antigen (CEA) level —a biomarker that tends to be elevated in patients with certain malignancies, including colorectal cancer — was 35 ng/mL. Slightly more than half (51%) had a KRASmutation, and 5% had a BRAF mutation at index.
The median time from CRC diagnosis to index date was 39.2 months, and 33% and 23% received Stivarga as a third-line or fourth-line treatment, respectively. Median time to Stivarga discontinuation was 7.3 months.
Findings showed that patient characteristics were similar among patients who had remissions lasting four months or longer, with 48% (241 patients) having stage 4 at diagnosis, 66% (332 patients) having an ECOG performance status of 0 to 1; 68% (341 patients) having prior Avastin; median CEA level of 40 and 54% and 6% harboring KRAS and BRAF mutations, respectively.
Median time from diagnosis to index was 38.6 months, with 34% and 23%, respectively, receiving Stivarga as a third-line or fourth-line therapy. The median time to treatment discontinuation was six months.
Among patients who started Stivarga therapy before the year 2019, (1,070 patients), 14% had a remission lasting five or more months, while 21% had a remission lasting four months or longer. In patients who started the therapy 2019 or later, (1,256 patients), 16% and 22% had remissions lasting five months and four months or longer, respectively.
“This is the first large-scale, real-world evidence study to describe demographic and clinical characteristics of patients with (metastatic colorectal cancer) with a long-term response to regorafenib in the USA,” the poster said.
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