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| |  Long-Term Benefits of Cisplatin Use Questioned in International Lung Cancer Trial: Presented at ASCO By Cameron Johnston CHICAGO -- June 3, 2008 -- The benefit of cisplatin seems to disappear after 5 years of follow-up, and researchers who followed patients for longer than 5 years found that the mortality risk in these patients was higher than it was among patients who did not receive cisplatin. Researchers with the International Adjuvant Lung Cancer Trial (IALT) reported these findings here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. Cisplatin is now one of the standard treatments for patients with non-small-cell lung cancer. But despite its long-established use, its benefits have, in general, been modest and long-term benefits have not been established. The study was conducted at 148 centres in 33 countries and originally enrolled 1,867 patients. After complete resection of their tumours, patients were treated with either 3 or 4 cycles of cisplatin together with vinorelbine, vindesine, vinblastin, or etoposide (n = 932), or they had no additional therapy after tumour resection (n = 935). The trial results were discussed in an oral session on June 1 by Thierry Le Chevalier, MD, Institute Gustave Roussy, Villejuif, France. An interim analysis reported previously showed that after a mean follow-up of 4.7 years there was a clear survival advantage favouring chemotherapy. There were 495 deaths in the treatment arm compared with 534 deaths in the control arm. In terms of disease-free survival, there were 544 events in the treatment arm compared with 588 events in the control arm. However, the situation changed considerably after the 5-year time point. Between the initial analysis (ie, at 4.7 years follow-up), and a long-term follow-up of 7.5 years, there were 83 additional deaths in the treatment arm and 56 in the control arm. For disease-free survival, there were 62 events in the treatment arm, compared with 43 events in the control arm. There was more non-lung-cancer mortality in the treatment arm compared with the control arm (25 vs 10 deaths), and more lung cancer-related deaths in the treatment arm than in the control arm (48 vs 37 deaths). Local recurrences were more frequent in the control arm than in the treatment arm (230 vs 181 cases). Distant metastasis was also more frequent in the control arm (378 vs 338). No clear interaction with covariates was found that could have explained the difference in outcomes, Dr. Le Chevalier said, although the absence of a protein known as excision repair cross-complementation group 1 was associated with better outcomes among patients who had received chemotherapy (hazard ratio [HR] 0.076). Overall, this study demonstrates an absolute benefit of 3.9% (HR 0.86) 5 years after chemotherapy treatment, but that the benefit is lessened after approximately 8 years of follow-up. This study confirms the efficacy of cisplatin therapy for at least 5 years in patients with resected non-small-cell lung cancer, Dr. Le Chevalier concluded, but the differences in outcomes after 5 years could suggest late adjuvant therapy related mortality. This underscores the need for regular monitoring of these patients and highlights the need for longer-term trials to evaluate treatment results and risks for treatment failure.
[Presentation title: Long-Term Results of the International Adjuvant Lung Cancer Trial (IALT) Evaluating Adjuvant Cisplatin-Based Chemotherapy in Resected Non-Small-Cell Lung Cancer (NSCLC). Abstract 7507]
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