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.

journal_name

Anticancer Res

journal_title

Anticancer research

authors

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

subject

Has Abstract

pub_date

1999-09-01 00:00:00

pages

4379-90

issue

5C

eissn

0250-7005

issn

1791-7530

journal_volume

19

pub_type

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