Purpose
Positive margins dominate clinical outcomes after surgical resections in most solid cancer types including head and neck squamous cell carcinoma. Unfortunately, surgeons remove cancer in the same manner they have for a century with complete dependence on subjective tissue changes to identify cancer in the operating room. To effect change, we hypothesize that epidermal growth factor receptor (EGFR) can be targeted for safe and specific real-time localization of cancer.
Experimental design
A dose escalation study of cetuximab conjugated to IRDye800 was performed in patients (n=12) undergoing surgical resection of squamous cell carcinoma arising in the head and neck. Safety and pharmacokinetic data were obtained out to 30 days post-infusion. Multi-instrument fluorescence imaging was performed in the operating room and in surgical pathology.
Results
There were no grade 2 or higher adverse events attributable to cetuximab-IRDye800. Fluorescence imaging with an intraoperative, wide-field device successfully differentiated tumor from normal tissue during resection with an average tumor-to-background ratio of 5.2 in the highest dose range. Optical imaging identified opportunity for more precise identification of tumor during the surgical procedure and during the pathological analysis of tissues ex-vivo. Fluorescence levels positively correlated with EGFR levels.
Conclusion
We demonstrate for the first time that commercially available antibodies can be fluorescently labeled and safely administered to humans to identify cancer with sub-millimeter resolution, which has the potential to improve outcomes in clinical oncology.
Persistent type 2 endoleak is associated with an increased incidence of adverse outcomes, including aneurysm sac growth, the need for conversion to open repair, reintervention rate, and rupture. These data suggest that patients with persistent type 2 endoleak (>6 months) should be considered for more frequent follow-up or a more aggressive approach to reintervention.
Operative mortality was halved with SG, with similar late survival for both cohorts. Reinterventions were required at a nearly identical rate for open repair and SG, and both groups experienced similar rates of spinal cord ischemic complications.
EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.
These data suggest CFE should remain the standard of care for occlusive disease of the CFA. Its safety and efficacy establish a standard for comparison with emerging endovascular therapies.
EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming suitable AAA anatomy, these data justify a broad application of EVAR across a wide spectrum of patients.
Symptomatic recurrence requiring reintervention is common (overall 16/80 [20%]) after open and endovascular treatment for CMI. PTA/Stent was associated with decreased primary patency, primary assisted patency, and the need for earlier reintervention. In-hospital mortality or major morbidity were similar in patients undergoing PTA/Stent and OR. These findings suggest that OR and PTA/Stent should be applied selectively in CMI patients in accordance with individual patient anatomic and comorbidity considerations.
Femoropopliteal PTA can be performed with a low perioperative morbidity and mortality. Intermediate primary patency is directly related to TASC classification. Although secondary intervention is often necessary to maintain patency in TASC C/D lesions, these data suggest that it would be appropriate to use PTA as initial therapy for chronic femoropopliteal occlusive disease regardless of clinical classification at presentation or TASC category of lesion severity.
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