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Long-term Local Control Following CEA-targeted Fluorescence-guided Surgery in Patients With Locally Advanced and
Mats I Warmerdam1, Davy M J Creemers2,3, Miranda Kusters4
1Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. m.i.warmerdam@lumc.nl.
Molecular Imaging and Biology
|June 5, 2025
Summary
Near-infrared fluorescence (NIRF) guided surgery using SGM-101 showed no overall long-term benefit for rectal cancer patients. However, patients whose surgery was altered by NIRF imaging had better long-term outcomes.
Area of Science:
- Oncology
- Surgical Oncology
- Medical Imaging
Background:
- Previous phase 2 trials utilized SGM-101, a CEA-targeted fluorescent agent, for real-time near-infrared fluorescence (NIRF) guided surgery in rectal cancer.
- SGM-101 demonstrated intraoperative benefits, including enabling additional tumor removal and supporting less invasive surgical approaches.
Purpose of the Study:
- To evaluate the long-term tumor control outcomes for rectal cancer patients who participated in the SGM-101 phase 2 trial.
- To determine if the intraoperative benefits of NIRF-guided surgery translate to improved long-term oncological results.
Main Methods:
- Follow-up data were collected for all 29 locally advanced (LARC) and locally recurrent rectal cancer (LRRC) patients from the phase 2 trial.
- The primary outcome measure was 5-year local tumor control.
Main Results:
- The median follow-up was 5.0 years. Local recurrence occurred in 25% of LARC patients and 65% of LRRC patients.
- Patients who underwent less invasive NIRF-guided surgery remained recurrence-free. Patients with R0 resection due to SGM-101 had a 33% re-recurrence rate.
Conclusions:
- While SGM-101 guided surgery led to intraoperative changes, no overall long-term benefit in tumor control was observed for the entire cohort.
- A subset of patients experiencing surgical modifications based on NIRF imaging demonstrated favorable long-term outcomes.
- Further results from ongoing larger trials are anticipated to clarify the role of NIRF-guided surgery.
