The utility of tolonium chloride rinse in the diagnosis of recurrent or second primary cancers in patients with prior upper aerodigestive tract cancer.
BACKGROUND
The clinical utility of tolonium chloride rinse was compared with unaided visual examination alone in the diagnosis of oral carcinoma in patients previously treated for carcinoma of the upper aerodigestive tract.


METHODS
A total of 668 patients were enrolled in this multicenter study. At each site, an oral clinical visual examination was completed by one investigator followed by tolonium chloride rinse and examination by a second investigator blinded to the examination findings of the first investigator. If a lesion was considered suspicious (urgent biopsy required at the first visit), the lesion was biopsied after tolonium chloride rinsing. Patients with lesions characterized at the first visit as not suspicious (biopsy not urgent) or that stained with tolonium chloride were asked to return for a second visit. At the second visit, any residual lesion or lesions that retained tolonium chloride were biopsied.


RESULTS
A total of 96 biopsies was performed in 81 of the 668 patients (12.1%), of which 30 (31.3%) were diagnosed histologically as carcinoma/carcinoma in situ (CIS) and the remainder as inflammation (31.3%), keratosis (26.6%), dysplasia (21.9%), ulcer (2.1%), other (3.1%), or no abnormality (1.0%). Of the 30 lesions with the diagnosis of carcinoma/CIS, 12 (sensitivity 40.0%) were considered to be clinically suspicious (CS+), whereas 29 (sensitivity 96.7%) retained tolonium chloride (p =.0002). The predictive values of a positive test for clinical examination and tolonium chloride staining were similar (36.4% vs 32.6%; p =.5871), indicating that the greater sensitivity of tolonium chloride was not associated with an excessive number of unnecessary biopsies (false positives).


CONCLUSIONS
Tolonium chloride rinse is more sensitive than clinical examination alone in detecting lesions that might be found on biopsy to be carcinoma or CIS. The increased sensitivity is largely attributed to lesions that stain but were not detected clinically on visual examination.
Epstein
Joel B
JB
Division of Dentistry, British Columbia Cancer Agency, 600 West 10th Avenue, Vancouver, British Columbia V5Z 4E6 Canada. jepstein@uic.edu
Feldman
Roy
R
Dolor
Rowena J
RJ
Porter
Stephen R
SR
D000368:Aged; D004396:Coloring Agents; D005260:Female; D006258:Head and Neck Neoplasms / Q000175:diagnosis* / Q000473:pathology; D006801:Humans; D007822:Laryngeal Neoplasms / Q000175:diagnosis*; D007972:Leukoplakia, Oral / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000175:diagnosis*; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis; D016609:Neoplasms, Second Primary / Q000175:diagnosis* / Q000473:pathology; D010157:Palatal Neoplasms / Q000175:diagnosis; D011237:Predictive Value of Tests; D014048:Tolonium Chloride; D014062:Tongue Neoplasms / Q000175:diagnosis; D014067:Tonsillar Neoplasms / Q000175:diagnosis
D004396:Coloring Agents; D014048:Tolonium Chloride