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Tumori. 2010 Jan-Feb;96(1):42-7.

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

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Medical Oncology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy.



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.


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.


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.


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.

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