Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus
January 2003
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BACKGROUND: We have previously reported a favourable response rate in patients with advanced esophageal cancer after treatment with a biweekly regimen of paclitaxel and cisplatin. In this study we investigate the feasibility and efficacy of this regimen in a neo-adjuvant setting. PATIENTS AND METHODS: Patients with resectable squamous cell carcinoma of the esophagus received paclit-axel 180 mg/m(2) and cisplatin 60 mg/m(2) every 2 weeks. Patients received three courses and responding patients received three additional courses; thereafter, patients were referred for surgery. Patient characteristics of 50 eligible patients were as follows: male, 60%; median age, 62 years (range 45-78); median World Health Organization performance status of 1 (range 0-2). RESULTS: Ninety-four per cent of patients received at least three courses of chemotherapy. Haematological toxicity consisted of National Cancer Institute-Common Toxicity Criteria grade 3 or 4 neutropenia in 71% of patients, with neutropenic fever occurring in only two patients (4%). The overall response rate was 59%. Pathological examination showed tumour-free margins in 38 patients. In seven patients no residual tumour was found. The median overall survival was 20 months and the 1- and 3-year survival rates were 68% and 30%, respectively. CONCLUSIONS: This dose-dense schedule of paclitaxel and cisplatin administered biweekly is well tolerated and the observed overall and complete response rates are promising.
- Male
- Comparative Study
- Dose-Response Relationship, Drug
- Aged
- Female
- Humans
- Middle aged
- Research Support, Non-U.S. Gov't
- Survival Analysis
- Treatment Outcome
- Probability
- Prognosis
- Drug Administration Schedule
- Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
- Paclitaxel/*administration & dosage
- Neoplasm Staging
- Infusions, Intravenous
- Carcinoma, Squamous Cell/*drug therapy/mortality/pathology/surgery
- Chemotherapy, Adjuvant
- Cisplatin/*administration & dosage
- Esophageal Neoplasms/*drug therapy/mortality/pathology/surgery
- Esophagectomy/methods
- Neoadjuvant Therapy
- patient
- chemotherapy
- study
- surgery
- response
- cancer
- paclitaxel
- cisplatin
- survival
- esophageal cancer
- course
- resection
- cell carcinoma
- treatment
- response rates
- esophageal
- carcinoma
- tumour
- trial
- regimen
