First Signs of Efficacy in Oncology Phase 1 Clinical Trials
Author Information
Author(s): Ferte Charles, Soria Jean-Charles, Penel Nicolas
Primary Institution: Département de Cancérologie Générale, Centre Oscar Lambret, Lille, France
Hypothesis
Can molecular targeted agents achieve clinical benefit at lower doses than traditional cytotoxics in phase 1 trials?
Conclusion
First signs of efficacy were less frequently reported at early dose levels for molecular targeted therapies compared to conventional cytotoxics.
Supporting Evidence
- The MTD was reached in 65.9% of all trials.
- First signs of efficacy were observed in 79.8% of trials.
- Molecular targeted agents showed less frequent MTD establishment compared to conventional cytotoxics.
Takeaway
This study looked at cancer trials to see if new drugs work at lower doses than older ones. It found that new drugs often don't show results as quickly as older ones.
Methodology
The study reviewed 317 phase 1 oncology trials published between January 1997 and January 2009, recording efficacy signs and maximum tolerated doses.
Potential Biases
Publication bias and lack of uniform reporting standards may misestimate the clinical benefit.
Limitations
The study is retrospective and relies on published data, which may introduce biases and variability in reporting.
Participant Demographics
Patients with advanced cancer who had exhausted standard care options.
Statistical Information
P-Value
p<0.0001
Confidence Interval
[69.7–81.5]
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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