Purpose To compare the activity and tolerability of
docetaxel/gemcitabine (DG) and vinorelbine/cisplatin (VC) combinations
in chemotherapy-naive non-small-cell lung cancer (NSCLC) patients.
Patients and Methods Patients with advanced NSCLC were randomly assigned
to receive either DG (gemcitabine 1,000 mg/m(2) [days 1 and 8] plus
docetaxel 100 mg/m(2) [day 8]) or VC (vinorelbine 30 mg/m(2) [days 1
and 8] plus cisplatin 80 mg/m(2) [day 8]) and prophylactic recombinant
human granulocyte colony-stimulating factor (150 mu g/m(2)
subcutaneously [day 9 through 15]) every 3 weeks.
Results A total of 413 randomly assigned patients were analyzed for
response and toxicity (DG, n = 197; VC, In = 192). Median survival was
9.0 and 9.7 months (P = .965) for DG and VC arms, respectively; the
corresponding 1-year survival rates were 34.3% and 40.8%,
respectively. Overall response rate was 30% (95% CI, 23.9% to 36.3%)
and 39.2% (95% CI, 32.5% to 45.9%; P = .053) for DG and VC,
respectively. Toxicity was as follows (DG v VC): grade 2 to 4 anemia,
34% v 55% (P = .0001); grade 3 to 4 neutropenia, 16% v 37% (P =
.0001); febrile neutropenia, 6% v 11% (P = .009); and grade 3 to 4
nausea and vomiting, 1% v 15% (P = .003). Nephrotoxicity occurred in
8% and ototoxicity in 2% of VC-treated patients. There were five and
six treatment-related deaths in the DG and VC arms, respectively.
Quality of life was improved in DG but not in VC patients.
Conclusion Although the two regimens produced comparable overall
survival, the DG regimen had a better toxicity profile. Therefore, DG
could be used in the first-line setting of advanced NSCLC, especially
for patients who cannot tolerate cisplatin
