Study: Data suggest novel approach to treat early-stage oral cancer

2015 04 20 15 39 28 178 Cancer Cell Target 200

Of the many ongoing issues around oral cancer treatment is a lack of "significant improvement" in disease prognosis over the last several decades. Now a study in JAMA Otolaryngology -- Head and Neck Surgery presents, for the first time, outcome data for almost 250 patients using a novel optical approach at the point of care to treat early-stage oral cancer.

The researchers' approach for this study involved the use of tissue autofluorescence and a fluorescence visualization (FV) device (VELscope, LED Medical Diagnostics) during surgery. The association between cancer development and a loss of normal tissue autofluorescence has been well-established, and visual aids using optical methods to detect loss of autofluorescence have been shown to reveal lesions undetected by the unaided eye, noted the authors from Cananda.

The fluorescence visualization device used in this study is the only such tool approved for commercial use by the U.S. Food and Drug Administration and Health Canada. If this device was "validated in a randomized clinical study, the device and its approach can be translated into real-world use, with an immediate effect on oral lesion assessment before surgery or in the operating room," wrote the study authors, led by Catherine Poh, DDS, PhD, an associate professor in the department of oral biological and medical science at the University of British Columbia (JAMA Otolaryngol Head Neck Surg, January 14, 2016).

New approaches needed

There is a "pressing need" for the development of new approaches that can be used easily in a clinical setting and that will aid the detection of clinically occult fields with a high risk for oral cancer, according to the authors.

Over a five-year period from 2004 to 2009, 246 eligible patients 18 years and older were recruited from a single oral oncology clinic for this retrospective, case-control observational study. Among the patients (mean age of 60, with standard deviation of 12 years; 108 women and 138 men), 156 had squamous cell carcinoma and 90 had high-grade lesions. For those patients with squamous cell carcinoma, 92 were in the FV group and 64 in the control group. Among those with high-grade lesions, 62 were in the FV group and 28 in the control group.

“Results support the use of FV ... in the control of local recurrence and provide a possible effective modality to control early-stage oral cancer and high-grade preinvasive oral lesions.”
— Catherine Poh, DDS, PhD, and colleagues

Among the 246 patients, 154 underwent surgery with FV guidance; the remaining 92 patients were treated with conventional surgery and served as the control group. The authors noted no significant differences between the groups in age, smoking history, anatomical site of the lesion, tumor size, and previous oral cancer.

Among the patients with squamous cell carcinoma, the FV group showed significant reduction in the three-year local recurrence rate, from 40.6% (26 of 64 patients) to 6.5% (6 of 92 patients) (p < 0.001). Likewise, among the patients with high-grade lesions, the FV group showed a reduction in local recurrence rate, from 39.3% (11 of 28) to 8.1% (5 of 62) (p < 0.001).

The results also indicated that, compared with conventional surgery, the approach using fluorescence visualization guidance for squamous cell carcinoma was associated with less regional failure and death. The authors cautioned, however, that these differences were not statistically significant.

For both groups, "the FV-guided approach was a strong and independent factor in the prediction of local recurrence," the authors wrote.

Phase III trial next

In this study, the use of fluorescence visualization as part of the surgical margin decision process significantly reduced the rate of local recurrence in preinvasive high-grade and early-stage oral cancers. An ongoing multicenter, phase III, randomized surgical trial has completed accrual, and the data will be used to validate the results of this study, according to the authors.

"This study's results support the use of FV as the strongest single independent factor in the control of local recurrence and provide a possible effective modality to control early-stage oral cancer and high-grade preinvasive oral lesions," they concluded.

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