Phase II study on dose escalating schedule of paclitaxel concurrent with radiotherapy in treating patients with locally advanced non-small cell lung cancer.

OBJECTIVE To evaluate clinical efficacy of a dose escalating schedule of paclitaxel concurrent with radiotherapy in treating patients with locally advanced non-small cell lung (NSCLC). METHODS Patients with locally advanced NSCLC were treated with conventional fractionated radiotherapy or three dimensional conformal radiotherapy (3 DCRT), concurrently with a dose escalating schedule of paclitaxel. All patients were divided into three groups, A with paclitaxel 30 mg/m2, B with paclitaxel 60 mg/m2 and C with paclitaxel 90 mg/m2. Paclitaxel was repeated every week for a total of 4 or 6 weeks. RESULTS Among 109 patients, response rates were 68.8%, 71.1% and 71.8% (p>0.05) for group A (n=32), B (n=38), and C (n=39) respectively. Accordingly, disease control rates were 81.3%, 81.6% and 82.1% (p>0.05). Progression-free survival time was 8.0 ± 5.0 months, 11.6 ± 6.1 months, and 14.8 ± 7.9 months (p<0.05), respectively. Overall survival time was 15. 4 ± 7.6 months, 18.2 ± 8.0 months, and 22.0 ± 7.6 months (p<0.05), one-year survival rates were 62.5%, 73.1% and 90.0% (p>0.05) and two-year survival rates were 31.3%, 38.5% and 50.0% (p<0.05) . Main side-effects were bone marrow suppression, radiation related esophagitis and gastrointestinal reaction. CONCLUSION In treating patients with NSCLC, concurrent chemoradiotherapy with paclitaxel improves early response compared with conventional fractionated radiotherapy or 3 DCRT. The survival rate was improved with the addition of paclitaxel, but there was an increase in adverse reactions when the dose of paclitaxel was increased.