Abstract
The effectiveness of different breast cancer follow-up procedures to decrease breast cancer mortality are still an object of debate, even if intensive follow-up by imaging modalities is not recommended by international guidelines since 1997. We conducted a systematic review of surveillance procedures utilized, in the last ten years, in phase III randomized trials (RCTs) of adjuvant treatments in early stage breast cancer with disease free survival as primary endpoint of the study, in order to verify if a similar variance exists in the scientific world. Follow-up modalities were reported in 66 RCTs, and among them, minimal and intensive approaches were equally represented, each being followed by 33 (50%) trials. The minimal surveillance regimen is preferred by international and North American RCTs (P = 0.001) and by trials involving more than one country (P = 0.004), with no relationship with the number of participating centers (P = 0.173), with pharmaceutical industry sponsorship (P = 0.80) and with trials enrolling > 1000 patients (P = 0.14). At multivariate regression analysis, only geographic location of the trial was predictive for a distinct follow-up methodology (P = 0.008): Western European (P = 0.004) and East Asian studies (P = 0.010) use intensive follow-up procedures with a significantly higher frequency than international RCTs, while no differences have been detected between North American and international RCTs. Stratifying the studies according to the date of beginning of patients enrollment, before or after 1998, in more recent RCTs the minimal approach is more frequently followed by international and North American RCTs (P = 0.01), by trials involving more than one country (P = 0.01) and with more than 50 participating centers (P = 0.02). It would be highly desirable that in the near future breast cancer follow-up procedures will be homogeneous in RCTs and everyday clinical settings.
Highlights
In the last years, a substantial increase in the number of women surviving breast cancer [1], the most frequent female cancer in the world [2-5], has been reported
We conducted a systematic review of the surveillance procedures utilized in phase III Randomized clinical trials (RCTs) of adjuvant treatments in early stage breast cancer in order to asses if a similar variance exists in the scientific world
6 papers report the use of tumor markers measurement during follow-up [46,48,57,75,82,88] and none includes the use of computed tomography scans, positron emission tomography scanning and magnetic resonance imaging
Summary
A substantial increase in the number of women surviving breast cancer [1], the most frequent female cancer in the world [2-5], has been reported This leads to the necessity to focus on breast cancer followup procedures for the high relevance they have for both patients and professional personnel [6]. The effectiveness of different breast cancer of debate [21-24], which reflects in the wide use of intensive surveillance and in the long-term follow-up period in everyday clinical practice [6,25-28]. Based on these premises, we conducted a systematic review of the surveillance procedures utilized in phase III RCTs of adjuvant treatments in early stage breast cancer in order to asses if a similar variance exists in the scientific world
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