title: 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.
abstract: We carried out a systematic review of new drugs active in non-small cell lung carcinoma (NSCLC). Fifty five phase II and III trials were reviewed (vinorelbine (19 trials), paclitaxel (15), gemcitabine (11), docetaxel (6), topotecan (2) or irinotecan (2)). The first four ones could be considered as active drugs when given as single agent. More information is required for the camptothecin derivatives. Four phase III randomised studies were available, all concerning vinorelbine. They showed that in combination with cisplatin, vinorelbine improved the response rate and perhaps survival, in comparison to vinorelbine alone and that vinorelbine was better than 5 fluorouracil and vindesine. A quantitative overview was impracticable, because of too few randomised trials. A qualitative overview was carried out using the European Lung Cancer Working Party score. The overall median quality score was 65.3%. There was no statistically significant difference between the drugs, but there was a positive correlation between the score and the number of patients. There was also an improvement of the quality score in favour of the randomised trials. Some important methodological aspects were often missing in the articles. In conclusion, gemcitabine, vinorelbine, paclitaxel and docetaxel are active against NSCLC but more good-quality data are required to define their exact role in the routine.
authors.affiliation: Service de Médecine, Institut Jules Bordet, Brussels, Belgium.
authors.forename: A P
authors.initials: AP
authors.lastname: Meert
authors.forename: T
authors.initials: T
authors.lastname: Berghmans
authors.forename: F
authors.initials: F
authors.lastname: Branle
authors.forename: F
authors.initials: F
authors.lastname: Lemaître
authors.forename: C
authors.initials: C
authors.lastname: Mascaux
authors.forename: E
authors.initials: E
authors.lastname: Rubesova
authors.forename: P
authors.initials: P
authors.lastname: Vermylen
authors.forename: M
authors.initials: M
authors.lastname: Paesmans
authors.forename: J P
authors.initials: JP
authors.lastname: Sculier
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077143:Docetaxel; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000031:analogs & derivatives / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D043823:Taxoids; D019772:Topotecan / Q000627:therapeutic use; D014747:Vinblastine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D014747:Vinblastine; D000077146:Irinotecan; D019772:Topotecan; D017239:Paclitaxel; D000077235:Vinorelbine; D002166:Camptothecin; D000093542:Gemcitabine