Long-term results of a pilot study on an intensive induction regimen for unresectable stage III non-small-cell lung cancer.

BACKGROUND: In 1995, we designed and carried out a pilot study on the combination of cisplatin + high dose epirubicin + vinorelbine with granulocyte-colony-stimulating factor support for the induction treatment of unresectable stage IIIAN2 and wet IIIB non-small-cell lung cancer. The present report concerns the long-term results. METHOD: Eligible patients received cisplatin, 75 mg/m(2), and epirubicin, 120 mg/m(2), on day 1, vinorelbine, 25 mg/m(2), on days 1 and 15, and granulocyte-colony-stimulating factor, 300 microg s.c., from days 3 to 12. The cycle was repeated every 3 weeks for 3 times. Subsequently, all the patients were re-evaluated for surgical resection. RESULTS: Twenty-six patients were enrolled: 21 males and 5 females; median age, 55 years (range, 31-64); median performance status, 90% (range, 80-100); 16 stage IIIA and 10 IIIB. After the 3 cycles, objective response was as follows: 2 complete (8%), 18 partial (69%), 5 no change (19%) and 1 progressive disease (4%). Ten patients were not operated (9 unresectable and 1 refusal) and received radiotherapy. Sixteen patients (61%) underwent surgery and 14 were completely resected (54%). After a median follow-up of 84 months (range, 12-120), the median overall progression-free survival was 17 months (range, 2-104+): 47 months for resected and 8 months for nonresected patients. The median overall survival was 40 months (range, 4-123+): 87 months for resected and 13 months for nonresected patients. One-year, 3-year and 5-year survival rates were 73%, 42% and 37%, respectively. CONCLUSIONS: These intensive cytotoxic regimen enabled us to obtain favorable long-term results in a selected series of inoperable stage III non-small-cell lung cancer patients.

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/m2 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 dose of 25 mg/m2 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.