Docetaxel Administered Every Two Weeks as Second-line Chemotherapy for Advanced Non-small Cell Lung Cancer: A Phase II Study

Abstract

Background: The aim of this phase II study was to evaluate efficacy and toxicity of single-agent docetaxel, administered every two weeks as second-line treatment for patients with recurrent non-small cell lung cancer (NSCLC). Patients and Methods: Forty-eight patients with confirmed NSCLC were enrolled in this trial. The median age was 56.5 years (range 43-76), median PS was 1, and the main histology type was adenocarcinoma (54%). Only 8% of patients had previously received paclitaxel. Patients received docetaxel i.v., 50 mg/m² over 1 hour, on day 1 every 2 weeks. Results: The overall response rate was 8.3% (95% Confidence Interval 0.5-16.1%). The median time to disease progression, median survival time and 1-year survival rate were 3 months, 6 months and 21%, respectively. Grade 3-4 neutropenia was registered in 47% of patients, with only 1 patient (2%) experiencing febrile neutropenia. Non-hematological toxicity was mild (grade 1-2) and consisted mainly of asthenia (19%) and diarrhea (10%). Conclusion: The bi-weekly schedule of docetaxel showed an activity comparable to the standard tri-weekly 75 mg/m² schedule as second-line treatment for recurrent NSCLC. Though non-hematological toxicity is significantly reduced, myelosuppression is still a matter of concern.