Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy versus standard of care for locally advanced rectal cancer (UNION): a prespecified interim analysis of a multicentre, open-label, randomised, phase 3 trial.
Kaixiong Tao, Zhenyu Lin, Peng Zhang et al.
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In 30 seconds
UNION was a multicentre, open-label, randomised phase 3 trial at nine hospitals in China comparing neoadjuvant short-course radiotherapy followed by camrelizumab plus CAPOX with long-course chemoradiotherapy followed by CAPOX in patients with locally advanced rectal adenocarcinoma. In this prespecified interim analysis, the experimental group had a higher 3-year investigator-assessed event-free survival rate: 91·3% (95% CI 83·9-95·4) versus 77·4% (67·9-84·4), with a stratified hazard ratio of 0·33 (0·15-0·71; p=0·0029). The authors reported a similar safety profile between groups.
Key findings
- Three-year event-free survival was 91·3% (95% CI 83·9-95·4) with short-course radiotherapy, camrelizumab, and CAPOX versus 77·4% (67·9-84·4) with standard care.
- The stratified hazard ratio for event-free survival was 0·33 (0·15-0·71; two-sided log-rank p=0·0029).
- Treatment-related serious adverse events occurred in 22 (19%) experimental-group patients and 15 (13%) standard-of-care patients.
- One treatment-related death occurred in the experimental group and none in the standard-of-care group.
Why it matters
The interim results suggest that adding camrelizumab to a short-course radiotherapy and CAPOX neoadjuvant strategy may improve event-free survival compared with the trial’s long-course chemoradiotherapy-based standard-care regimen. This is clinically relevant because the comparison evaluates a complete treatment strategy, including postoperative therapy, in locally advanced rectal cancer; the findings should be interpreted in light of the interim analysis and trial population.
What to keep in mind
This is a prespecified interim analysis, and the trial was conducted at nine hospitals in China; the abstract does not report mature final event-free survival results.