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BACKGROUND Mucosal oral squamous cell carcinoma (SCC) accounts for 3–5% of all reported cancers, with a 5‐year survival rate of approximately 50%. Unfortunately, current detection means are of no value in diagnosing lesions early enough for cure, especially when they recur after resection. Postoperative radiotherapy and/or covering the resection site with reconstructive flaps (regional or free vascularized) often makes early diagnosis an impossible task. METHODS The authors examined the detection and treatment monitoring capacity of two relatively new tumor markers in the serum of SCC patients, comparing their levels with those in patients with other oral/perioral malignancies or benign oral tumors and with disease free, posttreatment SCC patients and healthy controls. RESULTS Values of sensitivity, specificity, and positive and negative prediction for Cyfra 21‐1 were 96%, 87%, 93%, and 53%, respectively, whereas those for tissue polypeptide specific antigen (TPS) were 69%, 87%, 93%, and 54%, respectively. Approximately 2–3 weeks after resection of the SCC lesion, Cyfra 21‐1 and TPS levels were reduced by 47% (P ≤ 0.003) and 36% (P ≤ 0.041), respectively. Cyfra 21‐1 levels in SCC patients were significantly greater than those of healthy patients by 73% (P ≤ 0.0001), patients with benign tumors by 74% (P ≤ 0.0003), and patients in disease remission by 66% (P ≤ 0.0002). Similarly, the TPS levels of SCC patients were significantly greater than those of healthy patients by 59% (P ≤ 0.0005), patients with benign tumors by 55% (P ≤ 0.0001), and patients in disease remission by 59% (P ≤ 0.0001). In two patients, a second, new SCC lesion was diagnosed within the follow‐up period, with increased tumor markers noted concomitantly with the diagnosis. CONCLUSIONS The accumulated data point to the suitability of the clinical usage of these two markers, especially Cyfra 21‐1, in the early detection of oral SCC lesions (primary, recurrent, or secondary) as well as for treatment monitoring. These results may open new avenues for the diagnosis and follow‐up of these patients and hopefully improve their treatment outcome. Cancer 1999;85:1018–25. © 1999 American Cancer Society.

Summary This study examines a new tumour marker, Cyfra 21-1, as a prognostic marker in predicting the survival of H&N cancer patients, and its correlation with clinical outcome during prolonged follow up of these patients. The study included 67 patients with primary detection of carcinoma of H&N. The survival of these patients was evaluated in correlation with the disease stage and Cyfra 21-1 levels at initial diagnosis. 38 patients were followed clinically and with serial assays for at least 12 months, or until recurrence was diagnosed. Cyfra 21-1 levels were determined periodically, using an Elisa kit. Patients with Cyfra 21-1 < 1.5 ng ml -1 had a higher survival rate compared to patients with Cyfra 21-1 ≥ 1.5 ng ml -1 (63% vs. 20%, respectively). The risk ratio of Ln(Cyfra 21-1) is 1.62 (P = 0.028). In a Cox regression model that included the disease stage and Ln(Cyfra 21-1), Ln(Cyfra 21-1) was preferred as the main parameter for predicting patients survival. In 83% of the 12 patients with recurrent or residual disease, Cyfra 21-1 was elevated before or during clinical detection of the recurrence. Cyfra 21-1 was found to be a prognostic marker for carcinoma of H&N, unrelated to the stage of the disease. Elevated levels of Cyfra 21-1 without clinical evidence of disease can be attributed to the marker's mean lead-time as compared to the clinical appearance of the disease.

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Mucosal oral squamous cell carcinoma (SCC) accounts for 3–5% of all reported cancers, with a 5‐year survival rate of approximately 50%. Unfortunately, current detection means are of no value in diagnosing lesions early enough for cure, especially when they recur after resection. Postoperative radiotherapy and/or covering the resection site with reconstructive flaps (regional or free vascularized) often makes early diagnosis an impossible task. The authors examined the detection and treatment monitoring capacity of two relatively new tumor markers in the serum of SCC patients, comparing their levels with those in patients with other oral/perioral malignancies or benign oral tumors and in disease‐free, post‐treatment SCC patients and healthy controls. Values of sensitivity, specificity, and positive and negative prediction for Cyfra 21‐1 were 96%, 87%, 93% and 53%, respectively, whereas those for tissue polypeptide specific antigen (TPS) were 69%, 87%, 93% and 54%, respectively. Approximately 2–3 weeks after resection of the SCC lesion, Cyfra 21‐1 and TPS levels were reduced by 47% (P≤0.003) and 36% (P≤0.041), respectively. Cyfra 21‐1 levels in SCC patients were significantly greater than those in healthy patients by 73% (P≤0.0001), in patients with benign tumors by 74% (P≤0.0003), and in patients in disease remission by 66% (P≤0.0002). Similarly, the TPS levels of SCC patients were significantly greater than those of healthy patients by 59% (P≤0.0005), of patients with benign tumors by 55% (P≤0.0001), and of patients in disease remission by 59% (P≤0.0001). In two patients, a second, new SCC lesion was diagnosed within the follow‐up period, with increased tumor markers noted concomitantly with the diagnosis. The accumulated data point to the suitability of the clinical usage of these two markers, especially Cyfra 21‐1, in the early detection of oral SCC lesions (primary, recurrent or secondary) as well as for treatment monitoring. These results may open new avenues for the diagnosis and follow‐up of these patients and hopefully will improve their treatment outcome. Henk Tideman