BACKGROUND: This prospective study was conducted to assess the efficacy and toxicity of induction chemotherapy with docetaxel and cisplatin for patients with previously untreated, locally advanced squamous cell carcinoma of the head and neck (SCCHN). METHODS: Forty four patients received 120 courses of treatment with docetaxel (70 mg/m2 in a 1-hour infusion) and cisplatin (75 mg/m2 in a 1-hour infusion), repeated every 3 weeks. Responsive patients (complete response: CR, or partial response: PR) received one more course of chemotherapy before undergoing local radiotherapy. RESULTS: All 44 patients were assessable for response and toxicity analysis. The most common grade 3/4 adverse events were neutropenia, which occurred in 23 patients. Four cases of febrile neutropenia were noted. The overall response rate was 90% (CR 45% & PR 45%). The four year probability of time to treatment failure was 56.3+/-10.2%. The four year estimated overall survival rates were 87.4+/-6.9%. CONCLUSIONS: Docetaxel and cisplatin induction chemotherapy shows considerable CR, with an acceptable toxicity profile in patients with locally advanced head and neck squamous cell carcinoma.
Carcinoma, Squamous Cell* ; Cisplatin* ; Drug Therapy ; Febrile Neutropenia ; Head and Neck Neoplasms ; Head* ; Humans ; Induction Chemotherapy* ; Neck* ; Neutropenia ; Prospective Studies ; Radiotherapy ; Survival Rate ; Time-to-Treatment

BACKGROUND/AIMS: To investigate the effects of esomeprazole and rebamipide combination therapy on symptomatic improvement in patients with reflux esophagitis. METHODS: A total of 501 patients with reflux esophagitis were randomized into one of the following two treatment regimens: 40 mg esomeprazole plus 300 mg rebamipide daily (combination therapy group) or 40 mg esomeprazole daily (monotherapy group). We used a symptom questionnaire that evaluated heartburn, acid regurgitation, and four upper gastrointestinal symptoms. The primary efficacy end point was the mean decrease in the total symptom score. RESULTS: The mean decreases in the total symptom score at 4 weeks were estimated to be −18.1±13.8 in the combination therapy group and −15.1±11.9 in the monotherapy group (p=0.011). Changes in reflux symptoms from baseline after 4 weeks of treatment were −8.4±6.6 in the combination therapy group and −6.8±5.9 in the monotherapy group (p=0.009). CONCLUSIONS: Over a 4-week treatment course, esomeprazole and rebamipide combination therapy was more effective in decreasing the symptoms of reflux esophagitis than esomeprazole monotherapy.
Esomeprazole* ; Esophagitis, Peptic* ; Heartburn ; Humans

BACKGROUND/AIMS: To investigate the effects of esomeprazole and rebamipide combination therapy on symptomatic improvement in patients with reflux esophagitis. METHODS: A total of 501 patients with reflux esophagitis were randomized into one of the following two treatment regimens: 40 mg esomeprazole plus 300 mg rebamipide daily (combination therapy group) or 40 mg esomeprazole daily (monotherapy group). We used a symptom questionnaire that evaluated heartburn, acid regurgitation, and four upper gastrointestinal symptoms. The primary efficacy end point was the mean decrease in the total symptom score. RESULTS: The mean decreases in the total symptom score at 4 weeks were estimated to be −18.1±13.8 in the combination therapy group and −15.1±11.9 in the monotherapy group (p=0.011). Changes in reflux symptoms from baseline after 4 weeks of treatment were −8.4±6.6 in the combination therapy group and −6.8±5.9 in the monotherapy group (p=0.009). CONCLUSIONS: Over a 4-week treatment course, esomeprazole and rebamipide combination therapy was more effective in decreasing the symptoms of reflux esophagitis than esomeprazole monotherapy.
Esomeprazole* ; Esophagitis, Peptic* ; Heartburn ; Humans