The ALPI Trial: the Italian/European experience with adjuvant chemotherapy in resectable non-small lung cancer.

Postoperative treatments for lung cancer have been evaluated for more than two decades, but in the majority of the studies no significant and clinically meaningful effect on survival has been shown. In 1995, a meta-analysis of eight cisplatin-based adjuvant chemotherapy trials in 1,394 patients with non-small cell lung cancer showed a 13% reduction in the risk of death (P = 0.08). The nonstatistically significant benefit reported in the meta-analysis prompted the planning of several randomized studies of platinum-based chemotherapy. Three studies addressed the issue of adjuvant chemotherapy in all the resected stages of non-small cell lung cancer (I-IIIA): the Italian/European study Adjuvant Lung Cancer Project Italy, the International Adjuvant Lung Cancer study, and the British Big Lung Trial. In contrast to the International Adjuvant Lung Cancer, the Adjuvant Lung Cancer Project Italy and the underpowered British Big Lung Trial failed to prospectively confirm a significant role of adjuvant chemotherapy in completely resected non-small cell lung cancer. In this article, we will discuss the findings of the Adjuvant Lung Cancer Project Italy study in the context of the International Adjuvant Lung Cancer and British Big Lung Trial.