LISBON, PortugalIn patients with advanced or metastatic
non-small-cell lung cancer (NSCLC), first-line docetaxel (Taxotere) plus
cisplatin (Platinol) has been shown to offer a survival advantage relative to a
standard regimen of vinorelbine (Navelbine) and cisplatin.
Frank V. Fossella, MD, medical director of the Thoracic Oncology
Multidisciplinary Care Center at M.D. Anderson Cancer Center, reported results
of the study (TAX 326) at the 11th European Cancer Conference (ECCO abstract
With more than 1,200 patients from 29 countries enrolled, TAX 326 is one of
the largest phase III trials ever conducted in NSCLC. Patients were randomized
to receive docetaxel 75 mg/m² plus cisplatin 75 mg/m² every 3 weeks; docetaxel
75 mg/m² plus carboplatin (Paraplatin) AUC 6 every 3 weeks; or a control
regimen of vinorelbine 25 mg/m²/wk plus cisplatin 100 mg/m² every 4 weeks.
"Overall survival in the docetaxel-cisplatin arm was greater than that
in the control group, with a significant P value of .044," Dr. Fossella
reported. "The curves separated at about 4 months and remained
nonoverlapping throughout the follow-up period."
The docetaxel-cisplatin regimen yielded a median survival of 11.3 months,
1-year survival of 46%, and 2-year survival of 21%, in contrast to
corresponding values of 10.1 months, 41%, and 14% for the control regimen (see
Table). "The objective response rate was also in favor of
docetaxel-cisplatin32% vs 25%, with a P value of .029," Dr. Fossella
The response rate, median survival, 1-year survival, and 2-year survival
were equivalent in the docetaxel-carboplatin and vinorelbine-cisplatin arms.
All three treatment arms were generally well tolerated, Dr. Fossella said.
The vinorelbine-cisplatin combination was responsible for the highest incidence
of grade 3-4 toxicity, including anemia, nausea, and vomiting, whereas diarrhea
was more common in patients treated with docetaxel-cisplatin.