[Comment] Effect of neoadjuvant chemoradiotherapy with or without PD-1 antibody sintilimab in pMMR locally advanced rectal cancer: a randomized clinical trial
Neoadjuvant chemoradiotherapy (NACRT) was the standard treatment for patients with locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) proteins. In this randomized phase 2 trial (ClinicalTrial. gov:NCT04304209), 134 pMMR LARC patients were randomly (1∶ 1) assigned to receive...
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| Format: | Article |
| Language: | zho |
| Published: |
Editorial Office of Journal of Colorectal & Anal Surgery
2025-02-01
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| Series: | 结直肠肛门外科 |
| Subjects: | |
| Online Access: | https://jzcgmwk.cbpt.cnki.net/WKD/WebPublication/paperDigest.aspx?paperID=e3116b37-ae1c-475b-b227-3a79824dcdd3 |
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| Summary: | Neoadjuvant chemoradiotherapy (NACRT) was the standard treatment for patients with locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) proteins. In this randomized phase 2 trial (ClinicalTrial. gov:NCT04304209), 134 pMMR LARC patients were randomly (1∶ 1) assigned to receive NACRT or NACRT and the programmed cell death protein 1 (PD-1) antibody sintilimab. As the primary endpoint, the total complete response (CR) rate is 26.9% (18/67, 95% confidence interval [CI] 16.0%-37.8%) and 44.8% (30/67, 95%CI: 32.6%-57.0%) in the control and experimental arm, respectively, with significant difference (P＝0.031 for chi-squared test). Response ratio is 1.667 (95%CI:1.035-2.683). Immunohistochemistry shows PD-1 ligand 1 (PD-L1) combined positive score is associated with the synergistic effect. The safety profile is similar between the arms. Adding the PD-1 antibody sintilimab to NACRT significantly increases the CR rate in pMMR LARC, with a manageable safety profile. PD-L1 positivity may help identify patients who might benefit most from the combination therapy. |
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| ISSN: | 1674-0491 |