Biweekly administration of docetaxel and gemcitabine as adjuvant therapy for stage II and IIIA non-small cell lung cancer: a phase II study.

ABSTRACT

BACKGROUND: The aim of this study was to determine the overall survival, progression-free survival, and toxicity associated with adjuvant administration of docetaxel and gemcitabine for completely resected patients with stage II and IIIA non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Thirty-nine eligible patients had surgical resection for pathological stage II or IIIA disease and received postoperative gemcitabine 1000 mg/m2 followed by docetaxel 80 mg/m2 on days 1 and 14. Cycles were repeated every 28 days. RESULTS: Treatment compliance was acceptable, at 83%. The median duration of follow-up, time to disease progression, and overall survival was 36.7 months, 17 months and 21 months, respectively. Toxicities were acceptable. Treatment failure revealed brain metastasis (15%), intrathoracic recurrence (24%) and systemic metastasis (36%). CONCLUSION: The biweekly administration of docetaxel and gemcitabine is a safe, well-tolerated and convenient chemotherapy regimen in the adjuvant setting of completely resected NSCLC stage II and III, with efficacy similar to that reported in other regimens. Hence, this nonplatinum based regimen appears promising and warrants further evaluation.