Impact of Patient Selection on Breast Cancer Trial Results
Author Information
Author(s): Bijker N, Peterse J L, Fentiman I S, Julien J-P, Hart A A M, Avril A, Cataliotti L, Rutgers E J T
Primary Institution: The Netherlands Cancer Institute
Hypothesis
How does patient selection affect the applicability of results from the EORTC 10853 trial on breast-conserving therapy for DCIS?
Conclusion
Patient selection significantly influences the outcomes of clinical trials, suggesting that results may not be applicable to all patients with ductal carcinoma in situ.
Supporting Evidence
- 52% of patients with DCIS were ineligible for the trial based on selection criteria.
- Patients not entered in the trial had higher local recurrence rates compared to those who were randomized.
- Reasons for non-entry included physician preference and patient refusal.
Takeaway
This study shows that not all patients with breast cancer are included in trials, which can change how well the results apply to everyone.
Methodology
The study analyzed patient selection and outcomes in five institutes participating in the EORTC 10853 trial, comparing randomized patients with those not entered.
Potential Biases
Differences in physician and patient preferences may introduce bias in trial participation.
Limitations
The study may not fully represent all patients with DCIS due to varying entry rates and selection criteria across institutes.
Participant Demographics
Patients treated for ductal carcinoma in situ across five cancer institutes in Europe.
Statistical Information
P-Value
0.03
Statistical Significance
p=0.03
Digital Object Identifier (DOI)
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