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.
According to the results of a multinational phase IIItrial reported at the 38th annual meeting of the American Society of ClinicalOncology (ASCO), the combination of docetaxel (Taxotere) and a platinum compoundleads to a significantly better quality of life than the combination ofvinorelbine (Navelbine) and cisplatin in chemonaive patients with advanced non-small-celllung cancer (NSCLC). The combination of vinorelbine and cisplatin is a standardfirst-line regimen for these patients.
"The data showed that patients who received docetaxel with eithercisplatin or carboplatin had an improved quality of life compared with patientstreated with vinorelbine plus cisplatin," said R. J. Gralla, MD, a leadinvestigator of the study and professor of medicine at Columbia UniversityCollege of Physicians and Surgeons in New York. Pain improvement was also betterwith the docetaxel combinations. The trial, known as Taxotere 326, is thelargest prospective evaluation of quality of life in patients with NSCLC whohave not received prior chemotherapy.
"An earlier analysis of clinical end points in this trial demonstratedthat docetaxel in combination with cisplatin produces a significant survivaladvantage compared to the vinorelbine/cisplatin combination," said Dr.Gralla.
Three Treatment Groups
The study included 1,218 patients with NSCLC from 28 countries and 140institutions. The median age of patients was 60 years, and about 75% were men.Approximately two-thirds of patients had stage IV disease, and in aboutone-third, disease had spread to at least three other organs.
Patients were randomized to one of three treatment groups. The first groupreceived docetaxel at 75 mg/m² and cisplatin at 75 mg/m² every 21 days. Thesecond group received the combination of docetaxel, 75 mg/m², and carboplatinat an area under the concentration-time curve (AUC) of 6, with treatmentrepeated every 21 days. The third group received the combination of vinorelbineat 25 mg/m²/wk and cisplatin at 100 mg/m² every 28 days.
Quality of life was assessed using two widely validated instruments: the LungCancer Symptom Scale (LCSS) and the European Organization for Research andTreatment of Cancer (EORTC) quality-of-life questionnaire (EQ-5D).Quality-of-life assessments were completed before each treatment cycle, at theend of study treatment, and every other month after the end of study treatment.
Results show that the global quality-of-life benefits of thedocetaxel/carboplatin combination over vinorelbine/cisplatin were statisticallysignificant using both the LCSS (P = .016) and the EQ-5D (P £ .001).The global quality-of-life benefits of docetaxel/cisplatin overvinorelbine/cisplatin were significant with the EQ-5D (P = .016).
Patients treated with the docetaxel/cisplatin combination experiencedsignificantly less pain than those treated with vinorelbine plus cisplatin (P = .033).They also had significantly less weight loss and a better performance statusthan patients who received vinorelbine with cisplatin.