We performed a study to determine the feasibility of a rapidly alternating administration of
cisplatin/
vinorelbine (CV) and
docetaxel/
gemcitabine (DG) in the treatment of advanced
non-small-cell lung cancer (NSCLC). Thirty-four patients with NSCLC (6% stage IIIB, 94% stage IV) were enrolled. The initial schema was to give CV on days 1 and 8 followed by DG on days 15 and 22, every 28 days.
Granulocyte colony-stimulating factor (
G-CSF) was used on days 9-14 and 23-28. Despite
dose reductions, this sequence was not feasible. Therefore, the sequence was switched to give DG before CV, cycle duration was extended to 35 days, and
G-CSF was given on days 2-7 and 23-28.
Neutropenia and
thrombocytopenia were dose-limiting toxicities. The recommended doses for phase II studies are
docetaxel 75 mg/m2 on day 1,
gemcitabine 1000 mg/m2 on days 1 and 8,
cisplatin 60 mg/m2 on day 15, and
vinorelbine 25 mg/m2 on days 15 and 22, every 35 days with
G-CSF 5 microg/kg on days 2-7 and 23-28. However,
treatment delays were required in subsequent cycles due to cumulative myelosuppression. A less intensive schedule is recommended for subsequent cycles for further testing. Overall response rate was 29% (95% confidence interval [CI], 14%-45%), and median survival for all patients was 11.8 months. One- and 2-year survival rates were 47% (95% CI, 30%-63%) and 14% (95% CI, 1.4%-40%), respectively. Although initial administration of this regimen was feasible, dose intensity could not be maintained in subsequent cycles due to cumulative myelosuppression. A sequential rather than alternating use of doublet regimens might be more readily feasible and may permit greater maintenance of dose intensity.