KEY TAKEAWAYS
- The phase III of ERASur trial aimed to evaluate the safety and efficacy of TAT for limited metastatic CRC.
- Patients with limited metastatic CRC were randomized to receive TAT or standard of care systemic therapy alone.
- The primary endpoint is OS, with secondary endpoints of EFS, treatment-related toxicities, and local recurrence.
- Study used a group sequential design with two interim analyses to stop for futility. Trial started in January 2023 and is still recruiting.
Local therapy for oligometastatic colorectal cancer (CRC) is effective for liver metastases, but less clear for other sites and extensive disease. ERASur is a phase III trial that evaluated the safety and efficacy of total ablative therapy (TAT) for limited metastatic CRC.
Study enrolled 364 patients with limited metastatic CRC (BRAF wild-type, microsatellite stable) with ≤4 sites of metastatic disease. Liver-only metastatic disease is not allowed. Patients receiving the initial systemic therapy for 4-6 months and are then randomized 1:1, stratified by certain factors like organ site (1-2 vs. 3-4), time of metastatic disease diagnosis (de novo vs. secondary). SBRT is required for at least one lesion.
Trial had two arms: Arm 1 receives TAT (SBRT ± MWA ± surgical resection) followed by standard systemic therapy, while Arm 2 continues with standard systemic therapy alone. The primary endpoint was the overall survival (OS), with secondary endpoints including event-free survival, treatment-related toxicities, and local recurrence. To achieve 80% power with a one-sided alpha of 5%, study needed 346 evaluable patients combined in both arms to demonstrate an improvement in OS with a hazard ratio of 0.7.
Study activated in January 2023, used a group sequential design with two interim analyses (25% and 50% of events) for futility.
Source: https://meetings.asco.org/abstracts-presentations/225844
Clinical Trial: https://www.clinicaltrials.gov/study/NCT05673148
Kathryn Hitchcock, Paul Bernard Romesser, Qian Shi, Jesse G. Dixon, Sepideh Gholami, Sarah B. White, Christina Wu, Christopher C. Goulet, Kyung-Wook Jee, Chadwick L. Wright, Rona Yaeger, Ardaman Shergill, Theodore S. Hong, Thomas J. George, Eileen Mary O’Reilly, Jeffrey A. Meyerhardt, and Eric David Miller | Journal of Clinical Oncology 2023 41:16_suppl, TPS3629-TPS3629
