title: Preliminary analysis of a phase II study of Paclitaxel and CHART in locally advanced non-small cell lung cancer.
abstract: Paclitaxel (Taxol; Bristol-Myers Squibb) is one of the most active single agents for non-small cell lung cancer (NSCLC), and ideal in combination with radiation therapy. We designed a phase II study to determine the efficacy and toxicity of continuous hyperfractionated accelerated radiotherapy (CHART) and concurrent weekly Paclitaxel (T) in good performance status patients with unresectable stage III A and B NSCLC. T (60 mg/m2) was given as a 3-h infusion on days 1, 8, 15, 22, 29 and 36; CHART was started on day 15 with 150 cGy/fraction given three times a day for a total dose of 54 Gy in 12 days with no weekend break. Twenty patients were evaluable for acute toxicity. The major acute toxicities were esophagitis and pulmonary toxicity; 70% of the patients experienced grade 2-3 esophagitis and 50% experienced grade > or = 3 pulmonary toxicity. Grade 3 anemia developed in only one patient. Of the 17 patients evaluable for late toxicity, 12% of the patients had grade 3 pulmonary toxicity, one patient developed grade 4 esophagitis. Nineteen patients were evaluable response. The overall response rate was 84% (95% confidence interval, 60-97). CHART with concurrent weekly T seems to be an effective regimen, but tolerability needs to be documented with a larger number of patients and longer follow-up.
authors.affiliation: University of Istanbul, Institute of Oncology, Istanbul, Turkey.
authors.forename: E N
authors.initials: EN
authors.lastname: Oral
authors.forename: S
authors.initials: S
authors.lastname: Bavbek
authors.forename: A
authors.initials: A
authors.lastname: Kizir
authors.forename: N
authors.initials: N
authors.lastname: Tenececi
authors.forename: A
authors.initials: A
authors.lastname: Yöney
authors.forename: E
authors.initials: E
authors.lastname: Kaytan
authors.forename: E
authors.initials: E
authors.lastname: Topuz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001706:Biopsy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011832:Radiation Injuries / Q000517:prevention & control; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011855:Radiodermatitis / Q000209:etiology; D012189:Retrospective Studies
chemical_list: D011838:Radiation-Sensitizing Agents; D017239:Paclitaxel