We carried out an open, randomized, phase III, multicenter clinical trial to compare, in neo-adjuvant setting, the clinical response and toxicity of the combination chemotherapy cisplatin + 5-FU with the same combination plus s.c. recombinant interleukin-2 (rIL-2) in patients with advanced (stage III IV) head and neck squamous-cell carcinoma (HNSCC). Regimen A was the classical Al Sarraf treatment: 100 mg/m2 cisplatin i.v. on day 1 plus 1000 mg m(-2) day(-1) 5-FU on days 1-5 as a continuous infusion. Regimen B was the same as regimen A plus 4.5 MIU/day rIL-2 s.c. on days 8-12 and 15-19. Treatment was repeated every 3 weeks for three cycles. A total of 33 patients were enrolled in the study; 30 were evaluable for toxicity and 28 for response. Seventeen patients were assigned to group A and 16 were assigned to group B. Three patients (20%) of group A and 4 (31%) of group B had a complete response, 9 patients (60%) of group A and 6 (46%) of group B had a partial response, with an overall response rate of 12 patients (80%) for group A and 10 patients (77%) for group B. Two patients (13%) of group A and 3 patients (23%) group B had stable disease; 1 patient (7%) of group A had progressive disease. Thus, there was not a statistically significant difference in response rate between the two groups and therefore there was no benefit from the addition of immunotherapy with rIL-2 to the standard chemotherapy. Both regimens were well tolerated. There were 2 toxic deaths (6.7%), 1 from hematological causes in group A and I from cardiac causes in group B. Myelosuppression and gastrointestinal toxicity, mainly nausea/vomiting and stomatitis, were the most frequent toxicities. The calculated number of patients for the sample has not yet been reached; however, the projection of our present results suggests that it is highly improbable that a clinically significant difference between the two treatment groups will be observed even if the calculated patient sample size is achieved.

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As a result of their presence throughout the mouth in the submucosa or between muscle fibers, minor salivary glands secrete directly and continuously into the oral cavity, providing mucosal surfaces with highly glycosylated proteins that are active in bacterial aggregation and in oral tissue lubrication. In this study, we investigated the ultrastructural localization of the MUC5B and MUC7 mucins in human labial glands by means of a postembedding immunogold technique. Thin sections of normal human labial glands, obtained during surgery, were incubated with polyclonal antibodies to human salivary mucins MUC5B and MUC7, and then with gold-labeled secondary antibodies. Specific MUC5B reactivity was found in the secretory granules of mucous cells of all glands examined, and was associated with the luminal membrane of duct cells. MUC7 labeling was observed in the granules of both mucous and seromucous secretory cells of the glandular parenchyma. Quantitative analyses demonstrated that seromucous granules have higher immunogold labeling densities for MUC7 than mucous granules. Our immunohistochemical data extend the results of previous light microscopic studies of MUC5B and MUC7 localizations, pointing out the significant contribution of human labial glands in the secretion process of these two mucins.

Stage T1 through T3 lip cancers can be treated primarily by brachytherapy (BRTX), with or without external radiotherapy (ERT), with adequate safety margins and good results. In this study, the outcomes of BRTX were reviewed for patients treated at the Brachytherapy Department of the Istanbul University Oncology Institute (IUOE). The medical records of 41 patients registered at IUOE with a diagnosis of lip cancer between 1988 and 2003 were reviewed. The median follow-up time was 88 months (24-160 mo). Among these patients, 21 patients with a primary tumor, 14 with tumors arising postoperatively, and 6 with postoperative recurrence of tumor were treated using BRTX. A total of 33 patients (80%) received BRTX alone and 8 (20%) received BRTX and ERT. The 10-year local control rate was 100%, 93%, and 67% for patients treated with BRTX alone, BRTX and surgery, and those treated for postoperative recurrence, respectively (P<.02). For patients treated with BRTX only and BRTX plus surgery, specific disease-free survival was 95% and 94%, respectively, and overall survival was 93% and 100%, respectively; these differences were not statistically significant. One patient with a postoperative recurrence who had been treated with BRTX died as a result of lip cancer. No patients developed any ulcerations, intra-oral complications, or mandibular necrosis. In the BRTX only group, 83% had excellent or good cosmetic results. In the surgery group, 62% had a contour deformity. In lip cancer management, BRTX results were comparable for local control, survival, and minimal late effects in normal tissue. This is in accordance with current reports in the medical literature. Satisfactory results were observed in patients with stage T1 and T2 lesions who had been treated with BRTX only and in patients with stage T3 lesions who had been treated with BRTX plus ERT, without a need for additional treatment modalities.

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