KEY TAKEAWAYS
- The COLONGER observational trial aimed to assess the efficacy of REG treatment in patients with mCRC.
- The results revealed that 10% had LTR6, linked to good ECOG PS.
Currently, no biomarkers predict long-term benefits from REG treatment in patients with metastatic colorectal cancer (mCRC). Also, detailed studies on how patients respond to REG are lacking.
Richard D. Kim and team aimed to present real-world clinical practice data to understand treatment effectiveness using duration of treatment (DOT) for long-term patients treated with REG treatment.
Researchers conducted a retrospective study using the US Flatiron Health database. Patients with mCRC who were 18 or older and started REG monotherapy between July 1, 2013, and June 30, 2023, were included in the study. Groups were categorized based on treatment duration: ≥4 months (LTR4), ≥5 months (LTR5), or ≥6 months (LTR6).
The results showed that out of 2,444 eligible patients starting REG, 22% (n=544) had LTR4, 15% (n=367) had LTR5, and 10% (n=250) had LTR6. Most were treated in community settings (88%), and 60% initiated REG between 2019 and 2022. Median age across groups was 66 years, with most starting REG in the third treatment line (30-33%).
Follow-up ranged from 10.7 months for LTR4, 13.0 months for LTR5, and 14.6 months for LTR6. The median time to REG discontinuation was 6.0 months for LTR4, 7.4 months for LTR5, and 9.3 months for LTR6. Patients with LTR6 had the longest time from initial CRC diagnosis to REG start, and fewer had mCRC disease (stage IV) at initial diagnosis.
For patients initiating REG before 2019 (n=1061), 21% had LTR4, 14% had LTR5, and 9% had LTR6. Post 2019, 23% started LTR4, 16% LTR5, and 11% LTR6. This can be linked to the completion of phase 2 of the ReDOS study (Bekaii-Saab et al. Lancet Oncol 2019;20:1070).
The study concluded that 10% of patients had LTR6 in the large-scale RW study, showing the most prolonged benefit from REG. These patients had good ECOG PS, left-sided tumors, and had received prior bevacizumab.
The trial was sponsored by Bayer Healthcare Pharmaceuticals.
Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3
Clinical Trial: https://www.clinicaltrials.gov/study/NCT06029010
Kim RD, Pan X, Zhang Y et al. (2024). “Real-world (RW) study of metastatic colorectal cancer (mCRC) patients (pts) with long-term response (LTR) to regorafenib (REG) in the USA: An updated analysis.” Presented at ESMO GI 2024 (83P).
