Development and validation of an instrument for the measurement of health-related quality of life based on view of traditional chinese medicine perspective.

OBJECTIVES: The objectives of this study were to develop and validate an instrument for the measurement of health-related quality of life (HRQoL) based on view of Traditional Chinese Medicine (TCM). DESIGN: Six domains of questions, five questions for each domain were developed about general health, and health of five major viscera according to TCM theory to measure the HRQoL. SETTINGS: 149 patients participated in this study and all of them were interviewed in the TCM clinic of a medical center. INTERVENTIONS: When interviewing, these patients' health conditions of the five viscera were rated by a TCM physician without knowledge of the patient's answers. A telephone interview was conducted one week later as a retest. MAIN OUTCOME MEASURES: Test-retest reliability (intraclass correlation coefficient, ICC), internal consistency (Cronbach's alpha coefficient), and the ability to differentiate the health conditions in each domain of the patients were assessed. RESULTS: The test-retest reliability coefficients of the six domains ranged from 0.46 for spleen to 0.69 for liver-male and kidney. The internal consistency coefficients of the six domains varied from 0.38 for spleen to 0.72 for heart. All scales except that of liver for females could significantly classify different health conditions (evidence of abnormality) assessed by TCM physicians. Ten factors were identified through factor analysis. Some items were found to be correlated with more than one domain. Most domains in the questionnaire had fair test-retest reliability and fair to good internal consistency, and could differentiate patients' health conditions. The low internal consistency of the spleen scale and the inter-related scale structures needs further evaluation.

Phase I and pharmacokinetic study of oral thalidomide in patients with advanced hepatocellular carcinoma.

PURPOSE: To evaluate the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), and pharmacokinetics of thalidomide in patients with advanced hepatocellular carcinoma (HCC). METHODS: Patients with advanced HCC who were not feasible for definitive local therapy were eligible. Patients were enrolled in a cohort of three to receive thalidomide twice daily for 1 week to determine the MTD. Intra-patient dose escalation was permitted. Pharmacokinetic studies were performed at the first dose level and repeated at the second dose level of each patient. RESULTS: Fifteen patients were accrued at four dose levels with the starting dose range 100-400 mg/day. Two patients at 400 mg/day experienced DLT (grade 3 angioedema and dyspnea, respectively). The MTD of twice-daily schedule was determined as 300 mg/day. The mean steady-state maximal blood concentration and mean steady-state area under the curve had a trend toward positive correlation, but non-linear proportionate, to the daily dose of thalidomide. Pharmacokinetic parameters are comparable for patients of Child-Pugh's A and B. Apparent mild, transient drug-induced transaminitis was early onset, self-limited, which occurred in 30.7% of patients. Serum hepatitis B or C viral titers was largely not affected. CONCLUSION: The absorption and elimination of thalidomide are not significantly different in HCC patients with compensated or decompensated hepatic dysfunction.

A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients.

PURPOSE: To evaluate the role of adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma (NPC) patients, we conducted a randomized Phase III trial comparing radiotherapy (RT) followed by adjuvant chemotherapy to RT alone in patients with advanced NPC. METHODS AND MATERIALS: Between November 1994 and March 1999, 157 patients with Stage IV, M(0) (UICC/AJCC, 1992) advanced NPC disease were randomized to receive standard radiotherapy, as follows: 35-40 fractions, 1.8-2.0 Gy/fraction/day, 5 days/week, to a total dose 70-72 Gy with or without 9 weekly cycles of 24-h infusional chemotherapy (20 mg/m(2) cisplatin, 2,200 mg/m(2) 5-fluorouracil, and 120 mg/m(2) leucovorin) after RT. Of 157 patients enrolled, 154 (77 radiotherapy, 77 combined therapy) were evaluable for survival and toxicity analysis. RESULTS: With a median follow-up of 49.5 months, the 5-year overall survival and relapse-free survival rates were 60.5% vs. 54.5% (p = 0.5) and 49.5% vs. 54.4% (p = 0.38) for the radiotherapy-alone group and the combined radiotherapy and adjuvant chemotherapy group, respectively. The Cox regression showed that the hazard rates ratio of combined treatment to RT alone was 0.673 (p value = 0.232); the 95% confidence interval was 0.352 and 1.288, respectively. Patients who received combined treatment had a lower systemic relapse rate than radiotherapy-alone patients, according to relapse pattern analysis. The incidence of leukopenia (>or= Grade 3) occurred in 17 out of 819 (2.1%) cycles of weekly chemotherapy. No patient developed moderate to severe mucositis (>or= Grade 3). CONCLUSIONS: We conclude that adjuvant chemotherapy after RT for patients with advanced NPC has no benefit for overall survival or relapse-free survival.