Planned sequence of gemcitabine followed by vinorelbine in the treatment of elderly patients with advanced non-small cell lung cancer.

Background: The rationale for planned sequential chemotherapy is based on the principle that sequential administration of non-cross-resistant cytotoxic agents has the advantage of eliminating additive toxicity and permitting the delivery of full doses of each drug. At present, there is a lack of data on the results of planned sequential single agent administration in elderly patients with advanced non-small cell lung cancer (NSCLC). The aim of this study was to explore the possibility of increasing the time-to-progression (TTP) by a 1.5 factor in comparison with the historical results of monochemotherapy with a first-line planned sequential administration of gemcitabine (GEM) and vinorelbine (VNR). Patients and Methods: GEM 1000 mg/m(2) was administered intravenously (i.v.) for 30 min on days 1, 8 and 15 and recycled on day 28 for a total of 3 cycles. Independently of response, VNR was administered i.v. as a bolus at a close of 25 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. VNR treatment was continued until disease progression or intolerance. Results: Fifty-two consecutive patients, with a median age of 76 years (70-85), affected by locally advanced (35%), metastatic (54%) or recurrent (11%) NSCLC were enrolled. The overall best objective response was 3.8% CR, 19.2% PR, 32.7% SD, 23.1% disease progression and 21.2% not evaluable. Both drugs were well tolerated. The median TTP was 6 months (95% confidence limits 4-8), the median overall survival was 10 months (95% confidence limits 6-14) and the one-year survival rate was 42%. Conclusion: The planned sequential administration of GEM and VNR suggests that the TTP can be increased with the use of the 2 single agents in elderly patients with locally advanced or metastatic NSCLC.