FDA Approves Docetaxel for Advanced NSCLC

Docetaxel (Taxotere) was recently approved by the Food and and Drug Administration (FDA) for the treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.

“Taxotere is the first chemotherapeutic agent to be approved by the FDA for the second-line treatment of advanced non–small-cell lung cancer,” said John Leone, senior vice president, US Commercial Operations, Aventis Pharmaceuticals (the company created by the recent merger between Hoechst Marion Roussel, Inc., and Rhone-Poulenc Rorer Pharmaceuticals, Inc.). “We hope this new approval for Taxotere will enable physicians to extend the lives of non–small-cell lung cancer patients who previously had limited options once their disease had progressed.”

The approval of this new indication for docetaxel was based on the results of two randomized, phase III clinical trials conducted in patients with advanced NSCLC.

“We found that patients treated with Taxotere in the second-line setting had a significant improvement in their survival,” said Frank V. Fossella, MD, medical director, Thoracic Medical Oncology Multidisciplinary Care Center at The University of Texas, M. D. Anderson Cancer Center in Houston, and primary investigator of one of the trials. “Standard treatment regimens for this patient population have shown no evidence of survival improvement. With the 1-year survival rates seen in both trials, Taxotere should be considered the standard of care for these patients with advanced non–small-cell lung cancer.”

Docetaxel vs Best Supportive Care

In a worldwide, multicenter, phase III trial, 204 patients who had not responded to previous platinum-based chemotherapy received either 75 or 100 mg/m² of docetaxel every 3 weeks plus best supportive care or best supportive care alone. Patients treated with docetaxel had a median survival of 7.5 months vs 4.6 months in patients who received best supportive care alone. The times to disease progression were 12.3 and 7 weeks in the docetaxel and best supportive care groups, respectively. The 1-year survival rate was significantly higher in group treated with docetaxel than in the group who received best supportive care alone (37% vs 12%).

A clinical-benefit analysis showed that patients treated with docetaxel did not experience a deterioration in performance status or body weight.

Docetaxel vs Vinorelbine or Ifosfamide

In the other phase III study, 373 patients with advanced NSCLC whose disease was resistant to platinum-based chemotherapy received treatment with docetaxel, 75 or 100 mg/m² every 3 weeks, vinorelbine (Navelbine), 30 mg/m² weekly, or ifosfamide (Ifex), 2 g/m² daily for 3 days every 3 weeks. The study, conducted at 23 cancer centers in the United States, found that patients treated with 75 mg/m² of docetaxel had a 1-year survival rate of 30%, as compared with a rate of 20% in patients treated with either vinorelbine or ifosfamide.

Side Effects

The major side effects of docetaxel in observed in both phase III trials were myelosuppression, fatigue, nausea, and alopecia.

In patients with normal liver function, side effects of docetaxel that have been reported include neutropenia, thrombocytopenia, anemia, fluid retention, hypersensitivity, nausea, and diarrhea. A premedication regimen with corticosteroids is recommended to prevent or reduce hypersensitivity and fluid retention. Docetaxel is generally not appropriate therapy for patients with liver impairment.