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Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non?Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens

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Frank V. Fossella, Russell DeVore, Ronald N. Kerr, et al.
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 2001

Source: Journal of Clinical Oncology, Vol 18, Issue 12 (June), 2000: 2354-2362

Introduction

Non-small cell lung cancer (NSCLC) is a leading cause of deaths related to cancer. Surgery is the treatment of choice, but only about 20% of tumors are suitable for potentially curative resection. Most patients with late stage or metastatic disease are treated palliatively. Recently, several new drugs have demonstrated a promising anti-tumor activity against NSCLC. However, with the relatively small absolute survival benefits observed for chemotherapy of non-small cell lung cancer, large numbers of patients are required to draw conclusions with confidence. In this randomized phase III study, the researchers compared docetaxel versus vinorelbine or ifosfamide in patients with advanced NSCLC.

Materials and Methods

A total of 373 patients with advanced NSCLC previously treated with platinum-based chemotherapy were included. Of them, 125 were randomized to treatment with docetaxel 100mg/m²(D100), 125 were randomized to 75 mg/m² (D75), and 123 patients to the vinorelbine or ifosfamide (V/I).

Results

• There was no complete response in all 3 arms.
• Patients received docetaxel treatment achieved better partial response, 10.8% vs 6.7% vs 0.8% for D100, D75, and V/I groups, respectively.
• The 1-year survival rate of 32% in the D75 group was significantly greater than the 19% in the V/I group.
• Patients treated with docetaxel experienced more toxicity, but the D75 arm was well tolerated.

Discussion

In this study, patients with advanced NSCLC appeared to benefit from a trial of docetaxel with a dose of 75 mg/m2 every 3 weeks. This study and other studies using similar regimen demonstrate that at a dose of 75 mg/m2, the benefits of docetaxel therapy outweigh the risks.