ABSTRACT: Effects of patient selection on the applicability of
results from a randomised clinical trial (EORTC 10853) investigating
breast-conserving therapy for DCIS
Selection of patients for randomised clinical trials may have
a large impact on the applicability of the study results to the
general population presenting the same disorder.
characteristics and outcome data on non-entered patients are
usually not available. The effects of patient selection for the
EORTC 10853 trial investigating the role of radiotherapy in breast
conserving therapy for ductal carcinoma in situ have been studied,
in an analysis of all patients treated for ductal carcinoma in
situ in five participating institutes.
The reasons for not entering
patients were evaluated and treatment results of the randomised
patients were compared to those not entered. A total of 910 patients
were treated for ductal carcinoma in situ. Of these, 477 (52%)
were ineligible, with the size of the lesion being the main reason
for ineligibility (30% of all ductal carcinoma in situ).
433 eligible patients, 278 (64%) were randomised into the trial.
The main reasons for non-entry of eligible patients were either
physicians' preference for one of the treatment arms (26%) or
patients' refusal (9%). These percentages showed significant
variation among the institutes. At 4 years follow-up, those patients
not entered in the trial and treated with local excision and
radiotherapy, had higher local recurrence rates than the patients
randomised in the trial and treated with the same approach, (17
vs 2%, P=0.03).
The patients treated with local excision alone
had equal local recurrence rates (11% in both groups). Selection
of patients may explain the differences in outcome of the randomised
patients, and those not-entered.
Thus, the results of this trial
may not be applicable to all patients with ductal carcinoma in
[09/24/2002; British Journal of Cancer]
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