KEY TAKEAWAYS
- The STAR-T observational study aimed to compare sequential R→T vs T→R in pts with mCRC.
- Researchers observed a modest survival benefit with R→T compared to T→R in pts with mCRC, consistent across treatment lines and liver metastases.
In a real-world (RW) study of patients (pts) with metastatic colorectal cancer (mCRC) treated sequentially with R→T or T→R in community clinical practice in the USA, R→T showed longer overall survival (OS) and time to treatment discontinuation (TTD). Liver metastasis and primary tumor sidedness are prognostic factors in mCRC.
Daniel Ahn and the team aimed to conduct an exploratory analysis of outcomes according to these factors and sequencing of R and T.
They performed an inclusive analysis using the nationwide de-identified Flatiron Health electronic health record-derived database. Patients aged ≥18 years at mCRC diagnosis were identified if treated sequentially with R→T or T→R between January 2015 and November 2022. The index date was defined as the initiation of the 1 therapy in the sequence. Clinical outcomes assessed included OS and TTD, stratified by primary tumor sidedness (left vs. right) and metastatic site (liver vs. non-liver).
About 818 pts (393 R→T; 425 T→R) were analyzed, predominantly receiving treatment in the third line (3L; 42%) or 4 line (4L; 24%). Baseline characteristics were comparable across cohorts. Most pts had left-sided (59%) or right-sided (28%) tumors, with liver (67%) or non-liver (23%) metastases. Median OS favored R→T vs T→R numerically in 3L pts with liver metastases or left-sided tumors, and in 4L pts with liver metastases or right-sided tumors.
The median TTD numerically favored R→T vs T→R in 3L pts with liver (hazard ratio [HR] 0.93; 95% CI 0.72, 1.22) and non-liver (0.84; 0.51, 1.41) metastases, in 4L pts with liver (0.79; 0.54, 1.15) and non-liver (0.91; 0.47, 1.77) metastases, and in 3L/4L pts with left-sided tumors (3L: HR 0.82; 0.61, 1.11; 4L: HR 0.71; 0.48, 1.05).
The study concluded that pts treated with R→T showed a numerical, modest improvement in outcomes compared to those treated with T→R, consistent across 3L/4L treatment lines and in pts with liver metastases.
The study was sponsored by Bayer.
Clinical Trial: https://clinicaltrials.gov/study/NCT05839951
Ahn D, Bekaii-Saab T, Yuan C, et al. (2024). “78P – Sequential regorafenib (R) and trifluridine/tipiracil ± bevacizumab (T) in refractory metastatic colorectal cancer (mCRC) in US clinical practice: Subgroup analysis by tumor sidedness and metastatic site.” Presented at ESMO-GI 2024 (Abstract 78P).
