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Comparing to trials with similar postmenopausal populations and longer follow-up periods, we see peak hazards at similar times.
The adjuvant arimidex versus tamoxifen versus combination study, as well as the early breast cancer trials meta-analysis also show early peak hazards for local risk of recurrence (LRR) between 2 and 3 years and within 2 years, respectively.
Confining our attention to patients of Chinese origin, we were able to confirm the presence of a double peak but, compared with the data reported by Demicheli and coworkers [ 5], these peaks occurred at slightly different timings (2.5 and 9.0 years, with corresponding peak hazards of 0.041 and 0.059; Figure 3a).
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In contrast, the BPC cohort's hazard rate for responders peaked higher compared to nonresponders, while the time of peak hazard rate is also delayed in responders compared to nonresponders.
CMAX; peak hazard.
TMAX; time (days) to peak hazard).
However, for NovoTTF-100A responders, the peak hazard rate was lower than that for nonresponders and the time of peak hazard rate was delayed compared to nonresponders.
Confidence in the TARGIT-A trial 4 year results is high because the peak hazard for local recurrence in the trial is between 2 and 3 years.
The results in both cohorts indicate that responders had a delay in tumor progression, but the higher peak hazard rate in the BPC cohort may be due to their tumor progression at nearly simultaneous time.
Summary of results (Fig. 3) Given that the peak hazard for local recurrence is early in all postmenopausal women, we would not expect the result of the TARGIT-A trial to change.
The statisticians were confident in the TARGIT-A results because data clearly show that the peak hazard rate for local recurrence is early, and is then low and stable, thus the overall conclusions are extremely unlikely to change.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com