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 (Taxotere) and a platinum compound
leads to a significantly better quality of life than the combination of
vinorelbine (Navelbine) and 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 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.
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.