Pilot study of concurrent 5-fluorouracil/paclitaxel plus radiotherapy in patients with carcinoma of the esophagus and gastroesophageal junction

Preoperative concurrent chemotherapy and radiotherapy can be highly effecti ve but are often associated with significant rates of morbidity and even mo rtality. We studied the toxicity of continuous infusion of 5-fluorouracil ( 5-FU) and weekly paclitaxel combined with radiotherapy. Patients had histol ogic proof of local-regional carcinoma of the esophagus or gastroesophageal (GE) junction, a Karnofsky performance status of 70 or greater, and normal liver, renal, and bone marrow functions. Chemotherapy consisted of continu ous infusion of 5-FU (300 mg/m(2)/d) For 5 days a week for 5 weeks, plus pa clitaxel (45 mg/m(2)) given during 3 hours every week for 5 weeks. Based on the tumor location and its resectability, the total dose of concurrent rad iation varied between 45 Gy and 50.4 Gy. Nine men and one woman, with a med ian age of 61 years, were evaluated. One had CIE junction cancer, six had d istal esophageal cancer, and three had midesophageal cancer. weight loss, n ausea, vomiting, and dysphagia of grades I and II were noted. The hematolog ic toxicity was mild. No patients required transfusion. There was no leukop enia or thrombocytopenia. None of the patients was hospitalized during chem oradiation: all patients completed treatment as outpatients. Five patients had subsequent surgical resections: one had a pathologically complete respo nse. and two had a partial response (>90% necrosis). Continuous infusion of 5-FU plus paclitaxel given concurrently with radiotherapy was well tolerat ed. We plan to study this regimen further in upper gastrointestinal cancers .