Posted: December 12, 2015

The impact of delay on the prognosis of newly diagnosed cancer is hotly debated among participants in malpractice litigation.  Much of the debate is focused on the statistical impact of delay and on mathematical models that are abstractions, and may not have any relationship to an individual cancer case.

Recently published are companion articles in JAMA Oncology about the impact of delay on the prognosis of newly diagnosed breast cancer.   Bleicher and colleagues (click here for link)  from FoxChaseCancerCenter in Philadelphia report on over 94,000 women with newly diagnosed breast cancer collected in the SEER database of the National Cancer Institute and the National Cancer Database of 115,000 patients from the AmericanCollege of Surgeons.  They examined time from diagnosis to the performance of definitive surgery as an independent variable in prognosis.   They grouped time to surgery in thirty-day increments — i.e., 30-60 days; 60-90 days, etc.   They then tried to find underlying causes for delay — such as race, urban vs. rural environment and the like.  There was no demographic trend in the various delay groups to explain an alteration in outcome other than the delay itself.  The increased risk of death (expressed as hazard ratio) was about 1.1 for each group compared to the one just before it — i.e., 60-90 days versus 30-60.  Comparing the group undergoing surgery most quickly to the one undergoing most slowly the increased risk of death was almost fifty percent higher stage for stage.  Fortunately for the group as a whole there were almost 200 times as many women having surgery fewer than 60 days from diagnosis compared to those over 120 days.  Why over 400 women in the SEER group waited that long is unknown to the authors.

In a companion piece by MacGregor and colleagues from MD Anderson Cancer Center in Houston (click here for link), the investigators looked at delay in initiating adjuvant chemotherapy as a risk factor.  They examined the California Cancer Registry, which contained data on over 24000 women from 2005-2010 who fit certain criteria, and broke them down by time to first chemo. In their study socioeconomic factors were a powerful predictor of delay. They found a huge 34% difference in outcome between early and late starters of chemo.  For women with “triple negative” (worst prognosis) the difference was a a whopping 51%.  Women who lived in the poorest neighborhoods had the longest delay and the worst outcome.  The authors did not relate stage to delay.

Dr. Stark comments “These studies show a remarkable difference in outcome with delay, much larger than the improvements seen with all the new cancer drugs. The results are surprising and troublesome, as medicine becomes ever more bureaucratic with attendant delays in getting appointments and initiating therapy. Insurance company authorization adds a further layer of unwelcomed intrusion. These studies, large and well done, should be a wake-up call.  The impact on litigation could be profound.  The delays in these trials were much shorter than those seen in the typical ‘failure-to-diagnose’ breast cancer case.”