Data presentation of results from randomized cancer clinical trials. The case for trials in advanced cervical cancer. A critical appraisal.

Abstract

In the last four decades, median survival has increased in advanced cervical cancer from 7.1 with single-agent cisplatin to 24 months with doublet chemotherapy plus bevacizumab plus pembrolizumab. Coinciding with the irruption of targeted therapy, we observe higher pricing of novel cancer drugs and results presentation aimed to positively impact the audience. The first could result in poor drug affordability and financial toxicity, while the second can give patients a magnified sense of progress. In this review, we briefly comment on study designs that may favor obtaining positive results but, most notably, how results are presented pertaining the latest randomized clinical trials in advanced cervical cancer.  We found that survival results are expressed in Hazard Risk (HR) reductions but communicated as a Relative Risk (RR) reduction for death. The HR of the control to the experimental regimen is given by exp[β]. An HR of 0.7 means an HR reduction of 30%. Risk reduction derived from HR may lead to a belief that the intervention can eliminate the chance of the event occurring, but decreased HR means a reduction in the speed of the event to happen, not the chances to occur. On the contrary, the "risk reduction" based on RR means that patients have less chance of having the event because RR is a binary measure (alive or dead). Further, Absolute Risks and Number-To-Treat (NNT), in addition to Relative Risk, are omitted. The issue of how the results of cancer clinical trials are presented deserves open discussion. After all, it is the patient's right to make an informed decision for embarking on any cancer treatment.