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Published on: September 27, 2024
Phase II trials in patients with carcinoma of unknown primary: a pooled data analysis
Antoine Adenis1, Charles Ferté, Nicolas Penel
1Département de Cancérologie Digestive et Urologique, Centre Oscar Lambret, Lille, France.
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.
