The most effective treatment for early-stage (I-IIIA) non-small cell lung cancer (NSCLC) is surgical resection. Despite surgical resection, 50–60% of patients with stages I–IIIA NSCLC relapse and die from their lung cancer.1,2 There have been attempts to reduce the risk of relapse and death from lung cancer by giving adjuvant chemotherapy to patients after surgical resection.3 This approach has been successful in patients with breast and colon cancer, where some patients with stage I–III disease are routinely given adjuvant hormonal therapy (breast cancer), chemotherapy, or both.
Small randomized trials for patients with early-stage NSCLC performed over the last 30 years have been jointly analyzed in a meta-analysis reported in 1995.3 This analysis showed a 5% survival advantage at 5 years for patients with surgically resected early-stage NSCLC treated with cisplatin-based chemotherapy compared with those on observation alone. This led to the planning and execution of multiple national and international trials that were adequately powered to look for this small benefit of an absolute increase of 5% at 5 years. The results of these trials have been reported in the last several years. The seven trials reviewed here are those that entered more than 150 patients with surgically resected stages I–IIIA NSCLC per arm. These trials are discussed in the order in which they have appeared in the literature or were presented at international meetings. The seven trials have used different types of chemotherapy, included different proportions of stages IA–IIIA NSCLC, and have different methods of reporting their results. In addition, a meta-analysis combining data from the five largest trials that used cisplatin-based chemotherapy also has been performed and reported recently.4
Mitomycin, Vindesine, and Cisplatin Adjuvant Trial for Patients with Resected Stage I–IIIA NSCLC
This trial is referred to as ALPI, an acronym for Adjuvant Lung Project Italy.2 Patients with stage I–IIIA who successfully underwent a complete resection of their NSCLC, including mediastinal lymph nodes, were eligible for this trial. The patients were randomized to treatment with mitomycin 8 mg/m2 on day 1, vindesine 3 mg/m2 on days 1 and 8, and cisplatin 100 mg/m2 on day 1 of a 3-week cycle or to observation. Adverse effects were monitored during the 21-day cycles, and dose adjustments were made based on the toxicities encountered. If tolerated, chemotherapy was given for three cycles. At each institution, investigators decided whether or not to administer chest radiotherapy after the completion of chemotherapy according to their institutional policy.
Cisplatin-Based Adjuvant Trial for Patients with Resected Stage I–IIIA NSCLC
This trial is referred to as IALT, an acronym for International Adjuvant Lung Cancer Trial.1 Patients with stage I-IIIA NSCLC who successfully underwent a complete resection of their tumor were eligible for this trial. The patients were treated with 80–120 mg/m2 of cisplatin given for three to four cycles of treatment in combination with etoposide, vinblastine, ...