Phase II and III studies with new drugs for non-small cell lung cancer: A systematic review of the literature with a methodology quality assessment

We carried our a systematic review of new drugs active in non-small cell lu ng carcinoma (NSCLC). Fifty five phase II and III trials were reviewed (vin orelbine (19 trials), paclitaxel (15), gemcitabine (11), docetaxel (6), top otecan (2) or irinotecan (2)). The first four ones could be considered as a ctive drugs when given as single agent. More information is required for th e camptothecin derivatives. Four phase III randomised studies were availabl e, all concerning vinorelbine. They showed that in combination with cisplat in, vinorelbine improved the response rate and perhaps survival, in compari son to vinorelbine alone and that vinorelbine was better than 5 fluorouraci l and vindesine. A quantitative overview was impracticable, because of too few randomised trials. A qualitative overview was carried out using the Eur opean Lung Cancer Wet-king Party score. The overall median quality score wa s 65.3 %. There was no statistically significant difference between the dru gs, but there was a positive correlation between the score and the number o f patients. There was also an improvement of the quality score in favour of the randomised trials. Some important methodological aspects were often mi ssing in the articles. In conclusion, gemcitabine, vinorelbine, paclitaxel and docetaxel are active against NSCLC bur more good-quality data are requi red to define their exact role in the routine.