Phase II trials in patients with carcinoma of unknown primary: a pooled data analysis.
BACKGROUND
The management of carcinoma of unknown primary site remains debatable. The literature data consists of about 29 phase-II studies investigating 38 regimens, providing a broad range of response rates (RR).


METHODS
We performed a pooled published data analysis to identify the factors influencing RR in these 29 studies.


RESULTS
In front-line treatment, the overall RR was 31% (430/1,380). At least nine factors significantly influenced the reported RR, excluding drugs under investigation, such as the impact factor of the journal, single-centre study, some eligibility criteria, central radiological review, sample size calculation based on statistical hypothesis and stratification. Two drugs seem to improve RR: cisplatin and doxorubicin. Two drugs seem to be associated with a worse RR: irinotecan and carboplatin.


CONCLUSIONS
This pooled data analysis illustrates that in a phase II trial setting, it is impossible to attribute the variation in RR solely to the modification of drugs under investigation.
Département de Cancérologie Digestive et Urologique, Centre Oscar Lambret, Lille, France.
Antoine
A
Adenis
Charles
C
Ferté
Nicolas
N
Penel
D017322:Clinical Trials, Phase II as Topic; D016001:Confidence Intervals; D006801:Humans; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy*; D016879:Salvage Therapy