According to the results of a multinational phase III trial reported at the 38th annual meeting of the American Society of Clinical Oncology (ASCO), the combination of docetaxel(Drug information on docetaxel) (Taxotere) and a platinum compound leads to a significantly better quality of life than the combination of vinorelbine (Navelbine) and cisplatin(Drug information on cisplatin) in chemonaive patients with advanced non-small-cell lung cancer (NSCLC). The combination of vinorelbine and cisplatin is a standard first-line regimen for these patients.
"The data showed that patients who received docetaxel with either cisplatin or carboplatin(Drug information on carboplatin) had an improved quality of life compared with patients treated with vinorelbine plus cisplatin," said R. J. Gralla, MD, a lead investigator of the study and professor of medicine at Columbia University College of Physicians and Surgeons in New York. Pain improvement was also better with the docetaxel combinations. The trial, known as Taxotere 326, is the largest prospective evaluation of quality of life in patients with NSCLC who have not received prior chemotherapy.
"An earlier analysis of clinical end points in this trial demonstrated that docetaxel in combination with cisplatin produces a significant survival advantage compared to the vinorelbine/cisplatin combination," said Dr. Gralla.
Three Treatment Groups
The study included 1,218 patients with NSCLC from 28 countries and 140 institutions. The median age of patients was 60 years, and about 75% were men. Approximately two-thirds of patients had stage IV disease, and in about one-third, disease had spread to at least three other organs.
Patients were randomized to one of three treatment groups. The first group received docetaxel at 75 mg/m² and cisplatin at 75 mg/m² every 21 days. The second group received the combination of docetaxel, 75 mg/m², and carboplatin at an area under the concentration-time curve (AUC) of 6, with treatment repeated every 21 days. The third group received the combination of vinorelbine at 25 mg/m²/wk and cisplatin at 100 mg/m² every 28 days.
Quality of life was assessed using two widely validated instruments: the Lung Cancer Symptom Scale (LCSS) and the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (EQ-5D). Quality-of-life assessments were completed before each treatment cycle, at the end of study treatment, and every other month after the end of study treatment.