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.

Fiche publication


Journal

Anticancer research

Auteurs

Membres identifiés du Cancéropôle Est :
Pr MASCAUX Céline


Tous les auteurs :
Meert AP, Berghmans T, Branle F, Lemaître F, Mascaux C, Rubesova E, Vermylen P, Paesmans M, Sculier JP

Résumé

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.

Mots clés

Antineoplastic Agents, therapeutic use, Camptothecin, analogs & derivatives, Carcinoma, Non-Small-Cell Lung, drug therapy, Clinical Trials, Phase II as Topic, methods, Clinical Trials, Phase III as Topic, methods, Deoxycytidine, analogs & derivatives, Docetaxel, Humans, Irinotecan, Lung Neoplasms, drug therapy, Paclitaxel, analogs & derivatives, Randomized Controlled Trials as Topic, Taxoids, Topotecan, therapeutic use, Vinblastine, analogs & derivatives, Vinorelbine

Référence

Anticancer Res.. ;19(5C):4379-90