Preliminary results of radiotherapy with or without weekly paclitaxel in locally advanced non-small cell lung cancer.

PURPOSE: In this study our objective was to evaluate the therapeutic significance of concurrent paclitaxel and radiotherapy compared with radiotherapy alone. PATIENTS AND METHODS: Patients with stage III A/B NSCLC were randomly assigned to receive either radiotherapy alone (group 2) or concurrent weekly paclitaxel with radiotherapy (group 1) in GMMA. Radiotherapy was given as a split-course schedule with the total dose of 56 Gy. Paclitaxel, 60 mg/m(2), was administered only to group 1 on the first day of each radiotherapy week. To assess differences between values, P values were calculated with the chi(2) test. A Mann Whitney U-test was used to assess significant differences between the two values. Actuarial survival curves were calculated by the Kaplan-Meier method.
RESULTS: There were 25 patients who underwent chemoradiotherapy and 26 who underwent radiotherapy only. Median follow-up was 14 months. The overall response rate was 92% and 70% for groups 1 and 2, respectively ( P= 0.003). Median survival was 15.2 months for group 1, and 12.0 months for group 2 ( P= 0.027).
CONCLUSION: Based on this response and the toxicity profile, outpatient split-course radiotherapy and weekly paclitaxel seems to be feasible and safe.

RCT Entities:   Population Interventions Outcomes