[A Prospective Randomized Study of Adjuvant Chemotherapy in Resected Stage IIIA-N2 Non-small Cell Lung Cancer.].

BACKGROUND

Lung cancer is one of the leading cause of cancer-related death around the world. Surgery is the primary treatment for patients with stage I, II, or IIIA non-small cell lung cancer (NSCLC). However, longterm survival of NSCLC patients after surgery alone is largely unsatisfactory. We undertook to determine whether adjuvant vinorelbine/paclitaxel plus carboplatin prolong overall survival among patients with completely resected stage IIIA-N2 nonsmall cell lung cancer.

METHODS

We randomly assigned patients with completely resected stage IIIA-N2 non-small cell lung cancer to vinorelbine/paclitaxel plus carboplatin or to observation

RESULTS

A total of 150 patients (1999-2003) underwent randomization to vinorelbine/paclitaxel plus carboplatin (79 patients) or observation. In both groups, the median age was 57 years, 73 percent were male, and 28 percents had squamous carcinoma. Chemotherapy caused neutropenia in 82 percents of patients (including grade 3 and 4 neutropenia in 42 percent) and there was no treatment-related death observed in this trial. After median follow-up of 39 months (range 1-110), overall survival was significantly prolonged in the chemotherapy group as compared with the observation group (33 months versus 24 months, Chi-square=4.363, P=0.037), as was disease-free survival (32 months versus 20 months, Chi-square=5.413, P=0.020). Five-year overall survival rates were 31.1 percent and 19.1 percent, respectively.

CONCLUSIONS

Adjuvant vinorelbine/paclitaxel plus carboplatin have an acceptable level of toxicity and prolongs disease-free and overall survival among patients with completely resected stage IIIA-N2 non-small cell lung cancer.