Phase II study of weekly docetaxel and cisplatin in patients with advanced recurrent and metastatic head and neck cancer.

OBJECTIVE: Response rates of presently used palliative chemotherapy for end-stage recurrent head and neck cancer are poor, but the regimes cause important toxicity. METHODS: A prospective phase II study was conducted to evaluate the activity and toxicity of a weekly combination of cisplatin and docetaxel in patients with recurrent head and neck cancer. From July 2003 to November 2004, 21 patients with metastatic neck disease were enrolled. Treatment consistent of 25 mg/m cisplatin and 35 mg/m docetaxel once a week for 3 weeks followed by 1 week without treatment for each cycle. The primary end point was median survival. Secondary end points were response rate (RECIST), time to progression, toxicity (NCI-CTC), and quality-of-life (EORTC QLQ-C30, QLQ-H&N35). RESULTS: Eight patients (42%) showed a partial response. Eight patients (42%) had stable disease. Progressive disease was seen in three patients (16%). The median follow-up time was 7.2 months (95% confidence interval [CI], 5.9-9.3 months). The median time to progression was 3.5 months (95% CI, 2.0-5.0 months). The median overall survival was 10.7 months (95% CI, 6.4-15.0 months). Grade 3 toxicities occurred in two patients (10%). A grade 4 adverse event was not recorded. Most global quality-of-life scores but not head and neck-specific scores are deteriorated after last chemotherapy. CONCLUSION: Weekly docetaxel and cisplatin is active in recurrent head and neck cancer and shows an excellent toxicity profile. Its influence on the stabilization of quality of life is less significant.

Trends but not individual values of central venous oxygen saturation agree with mixed venous oxygen saturation during varying hemodynamic conditions.

BACKGROUND: Previous studies found contradictory results regarding the question whether mixed venous oxygen saturation (Svo2) and central venous oxygen saturation (Scvo2) are equivalent. The inconsistency of study results may result from different study designs and different, partly questionable, statistical approaches. METHODS: The authors performed a prospective clinical trial comparing individual oxygen saturation values as well as the trend of values in blood from the superior vena cava (Scvo2), the right atrium (Srao2), and the pulmonary artery (Svo2) during varying hemodynamic situations. The subjects were 70 patients scheduled to undergo elective neurosurgical operations in the sitting position. Oxygen saturation was measured photospectrometrically in blood samples simultaneously taken at four different time points during supine and sitting positions. Statistical analysis was performed following the recommendations of Bland and Altman. RESULTS: Five hundred two comparative sets of measurements were obtained. Ninety-five percent limits of agreement ranging from +/-6.83 to +/-9.30% for single values were interpreted as clinically unacceptable. In contrast, correlations between changes of Svo2 and Scvo2 as well as of Svo2 and Srao2 were interpreted as clinically acceptable (R > or = 0.755, Pearson correlation coefficient; P < or = 0.0001). CONCLUSIONS: In this sample of patients, exact numerical values of Scvo2 and Srao2 are not equivalent to those of Svo2 in varying hemodynamic conditions. However, for clinical purposes, the trend of Scvo2 may be substituted for the trend of Svo2. In addition, previous studies investigating the agreement between Svo2 and Scvo2 were found to be lacking in their chosen statistical approaches.