Chest
Clinical Investigations: SURGERYPhase II Study of Neoadjuvant Chemotherapy With Gemcitabine and Vinorelbine in Resectable Non-small Cell Lung Cancer
Section snippets
MATERIALS AND METHODS
Patients with histologically confirmed NSCLC and stage IB (T2N0M0), IIA (T1N1M0), IIB (T2N1M0 and T3N0M0), or IIIA (T3N1M0 and T1-3N2M0) NSCLC were eligible for study participation. Patients with two lesions in one lobe (T4; stage IIIB) were also eligible, provided a lobectomy would encompass the satellite nodules. Patients with N2 disease were eligible if they were considered surgically resectable,ie, multistation lymph nodal involvement and bulky single-station lymph adenopathy were excluded
RESULTS
From January 2000 to March 2004, 62 patients were entered. The median age was 65 years (range, 32 to 82 years). Forty-five were men, and 17 were women. Pretreatment stages were IB (n = 27), IIA (n = 2), IIB (n = 13), IIIA (n = 15), and IIIB (n = 5). Adenocarcinoma was the most frequent histology (52%). Performance status was 0 in 33 patients and 1 in 29 patients. Seven patients reported weight loss, and 55 patients did not.
DISCUSSION
The study is the first to use a non-platinum doublet for induction chemotherapy in resectable NSCLC. The combination of vinorelbine and gemcitabine was well tolerated, and there was no chemotherapy-related mortality. Ninety percent of patients underwent thoracotomy, and 77% had a complete tumor resection. The 1-year and 2-year survival rates of 80% and 65% (87% and 74%, respectively, for patients with complete resections) and median survival time of 38.2 months were not different from those
ACKNOWLEDGMENTS
We wish to thank Amber Sapp and Carol Sherer for data management and clinical research support.
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This work was support by grants from Glaxo-Smith-Kline to Dr. Ramnath and Eli Lilly to Dr. Bepler.
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