The study, led by Hideaki Bando from National Cancer Center Hospital East, Chiba, Japan, was presented at the ASCO Gastrointestinal Cancers Symposium 2024 and published in the Journal of Clinical Oncology. The research was sponsored by the ARCADE Foundation, and the authors did not disclose any financial relationships.
- The study focused on patients with metastatic CRC receiving salvage-line care. Researchers proposed using patient data from the CRC ARCAD global database to create a synthetic control group for trials.
- The synthetic control arm is designed to mimic the behavior of a control group in a randomized clinical trial, useful in interpreting the effects of investigational treatments in trials lacking a control group.
- The research team analyzed 723 patients in the placebo arm of four randomized trials (CORRECT, RECOURSE, CONCUR, and TERRA) from the CRC ARCAD database.
- They examined the impact of various baseline characteristics and prognostic factors on outcomes.
Significant Prognostic Factors Identified:
- The number of metastatic sites, Eastern Cooperative Oncology Group (ECOG) performance status, liver or peritoneal metastases, and Royal Marsden Hospital Score were identified as significant prognostic factors.
- Specifically, having fewer metastatic sites, no liver or peritoneal metastases, a better ECOG performance status, and a lower Royal Marsden Hospital Score were associated with improved overall survival.
Implications for Clinical Trials:
- The findings suggest that these factors can be used to increase the accuracy of the proposed synthetic control arm in future clinical trials for metastatic CRC.
- This approach could potentially spare patients from the ethical and practical concerns associated with placebo control arms.
Study Limitations and Future Research:
- Potential heterogeneity between trials could limit the accuracy of the synthetic control arm.
- Further investigation into additional prognostic factors is needed to enhance the precision of this approach.