Paclitaxel and gemcitabine vs. paclitaxel and pegylated liposomal doxorubicin in advanced non-nasopharyngeal head and neck cancer. An efficacy and cost analysis randomized study conducted by the Hellenic Cooperative Oncology Group.

BACKGROUND: The prognosis of patients with recurrent and/or metastatic head and neck cancer (HNC) is poor. Median survival of these patients following chemotherapy is in the range of 6 to 9 months. In the present randomized phase III trial we compared two new combinations containing new drugs with proven activity in phase II studies with patients with HNC. PATIENTS AND METHODS: From November 1999 until November 2004, 166 eligible patients with HNC were enrolled in the study. They were treated with paclitaxel 175 mg/m(2) on day 1 and gemcitabine 1000 mg/m(2) on days 1 and 8 every 3 weeks (group A, 85 patients) or with paclitaxel, as in group A, and pegylated liposomal doxorubicin 40 mg/m(2) on day 1 every 4 weeks (group B, 81 patients). RESULTS: There was no significant difference in response rate (20% versus 29%, P = 0.21), time to disease progression (median; 4.4 months versus 6.0 months, P = 0.09) and survival (median; 8.6 months versus 11.05 months, P = 0.25). Both regimens were generally well tolerated. The most frequently reported side effect, apart from alopecia, was neutropenia. Overall, there was no significant difference in severe toxicity between the two treatment arms. CONCLUSIONS: The present study could not demonstrate a survival benefit with either regimen. Both treatments were well tolerated. Randomized studies comparing each of the two regimens with standard chemotherapy are warranted.

Dental and periodontal status of Sjögren's syndrome.

BACKGROUND: Sjögren's syndrome (SS) is one of the most common systemic autoimmune diseases in middle-aged women. The present study had the aim to examine the dental and periodontal condition in patients with SS in comparison with disease controls and to evaluate the influence of reduced salivary flow in the periodontal tissues. METHOD: We examined 24 patients with primary or secondary SS in comparison with 27 patients who had another autoimmune disease but no signs or symptoms of SS, as well as with 29 subjects who had a subjective feeling of xerostomia or xerophthalmia without exhibiting an underlying disease. The clinical evaluation included examination of the oral mucosa, determination of missing, decayed and filled teeth, fixed or removable prosthetic appliances, plaque index, gingival index, probing pocket depth, probing attachment level, oral hygiene habits and frequency of dental visits. Statistical analysis was performed using the 2-tailed Fisher exact and Kruskal-Wallis tests. RESULTS: No significant difference was found in the dental or periodontal condition of the 3 groups. The number of teeth, feelings and distal or mesial decay lesions correlated negatively with age, while the number of fixed prosthetic appliances correlated positively. The salivary flow was statistically lower in patients with SS and exhibited a negative correlation with the number of cervical decay lesions. It was also found that SS patients had better oral hygiene habits than subjects of the control groups. CONCLUSIONS: No significant,difference could be detected concerning the dental and periodontal status of SS patients, compared with that of patients with other immune diseases as well as with that of controls who had subjective xerostomia.

Prevalence of Sjögren's syndrome in a closed rural community.

OBJECTIVE: To define the prevalence of Sjögren's syndrome (SS) through an epidemiological survey in a closed rural community. The classification of SS is based on the validated criteria reported by a multicentre study performed in Europe and supported by the Epidemiology Committee of the European Community (EEC-COMAC Epidemiology). METHODS: The population under study consisted of 837 women aged 18 years or older, residing in the Astakos community of Aitoloakarnania, Greece. The study protocol was subdivided in two parts. In part I, an exhaustive epidemiological survey of these women was conducted in July and August of 1992. The validated questionnaire used in the survey assesses both ocular and oral involvement. In part II, 45 of the women reporting symptoms of both dry eye and dry mouth were approached for a full examination based on the validated set of classification criteria of SS. The full complement of the diagnostic tests was performed on 35 of these women. A subject is classified as a definite primary SS case if at least four of six items of the subject's test items are positive. If three of six items are positive the subject is classified as a probable primary SS case. RESULTS: The classification criteria for definite primary SS were satisfied by five women. This number corresponds to an estimated prevalence of 0.60% (exact 95% CI 0.19%, 1.39%). Probable primary SS was diagnosed for 25 women (prevalence = 2.99%). CONCLUSION: Because of the loss of follow up (10 of 45) and the use of slightly stricter criteria for inclusion of possible SS cases in part II of the study, we consider our estimate of the prevalence of SS to be conservative. This study concurring with other recent reports, suggests that SS is more prevalent than previously thought.