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In this study patients with completely resected stage IB or stage II non-small cell lung cancer were randomised to either adjuvant chemotherapy with vinorelbine and cisplatin (n = 242) or to observation (n = 240). The primary end point was overall median survival which was significantly prolonged in the chemotherapy group (94 v 73 months; adjusted p = 0.04). This corresponds to an overall survival advantage at 5 years of 15 percentage points (p = 0.03). Fewer patients in the chemotherapy group had disease recurrence (36.0% v 49.6%, p = 0.003). While subgroup analysis of stage IB patients did not show a significant improvement in survival, the overall analysis showed disease stage not to be a significant predictor of treatment effect. Improved survival was associated with chemotherapy and squamous histology, whereas shorter survival was associated with older age, male sex, and pneumonectomy compared with lesser resection. Side effects from chemotherapy were seen in many patients, but in comparable numbers to other reports: there were two deaths (0.8%) and febrile neutropenia was documented in 7%.
This study has continued the recent trend of showing survival advantage with adjuvant chemotherapy and demonstrates a greater benefit than previous reports. This may be due to the sole use of a modern chemotherapy regimen compared with previous studies. Is adjuvant chemotherapy now to be considered the standard of care for such patients undergoing complete resection? Probably, although further work should be done to delineate which patients are likely to obtain the greatest benefits while hopefully avoiding the severe morbidity which can be associated with chemotherapy.
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