Docetaxel consolidation therapy following cisplatin, vinorelbine, and concurrent thoracic radiotherapy in patients with unresectable stage III non-small cell lung cancer.

BACKGROUND: To evaluate the feasibility and efficacy of docetaxel consolidation therapy after concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS: The eligibility criteria included unresectable stage III NSCLC, no previous treatment, age between 20 and 74 years, and performance status 0 or 1. Treatment consisted of cisplatin (80 mg/m2 on days 1, 29, and 57), vinorelbine (20 mg/m2 on days 1, 8, 29, 36, 57, and 64), and thoracic radiotherapy (TRT) (60 Gy/30 fractions over 6 weeks starting on day 2), followed by consolidation docetaxel (60 mg/m2 every 3 to 4 weeks for three cycles).

RESULTS: Of 97 patients who were enrolled in this study between 2001 and 2003, 93 (76 males and 17 females with a median age of 60) could be evaluated. Chemoradiotherapy was well tolerated; three cycles of chemotherapy and 60 Gy of TRT were administered in 80 (86%) and 87 (94%) patients, respectively. Grade 3 or 4 neutropenia, esophagitis, and pneumonitis developed in 62, 11, and 3 patients, respectively. Docetaxel consolidation was administered in 59 (63%) patients, but three cycles were completed in only 34 (37%) patients. The most common reason for discontinuation was pneumonitis, which developed in 14 (24%) of the 59 patients. During consolidation therapy, grade 3 or 4 neutropenia, esophagitis, and pneumonitis developed in 51, 2, and 4 patients, respectively. A total of four patients died of pneumonitis. We calculated a V20 (the percent volume of the normal lung receiving 20 Gy or more) on a dose-volume histogram in 25 patients. Of these, five patients developed grade 3 or more severe radiation pneumonitis. A median V20 for these five patients was 35% (range, 26-40%), whereas the median V20 for the remaining 20 patients was 30% (range, 17-35%) (p = 0.035 by a Mann-Whitney test). The response rate was 81.7% (95% confidence interval [CI], 72.7-88.0%), with 5 complete and 71 partial responses. The median progression-free survival was 12.8 (CI, 10.2-15.4) months, and median survival was 30.4 (CI, 24.5-36.3) months. The 1-, 2-, and 3-year survival rates were 80.7, 60.2, and 42.6%, respectively.

CONCLUSION: This regimen produced promising overall survival in patients with stage III NSCLC, but the vast majority of patients could not continue with the docetaxel consolidation because of toxicity.