Colorectal cancer trial slammed as ‘the single worst reported RCT’

Cancer

By Nicola Garrett

24 Oct 2019

A phase III study in metastatic colorectal cancer has been slammed by a haematologist-oncologist as the “single worst reported randomised trial” he has ever read.

Presented at at the European Society for Medical Oncology conference in Barcelona and published simultaneously in the NEJM, the BEACON trial purported to show that triple therapy targeting BRAF mutations in progressive metastatic colorectal tumours significantly improved overall survival  compared to standard care.

But Dr Vinay Prasad, an associate professor of medicine at Oregon Health and Science University in Portland, Oregon, criticised the BEACON study on Twitter for failing to answer many basic and key questions that doctors would want to know, such as what percentage of patients received adjuvant therapy, what adjuvant therapies were given and for how many cycles?

In a podcast [listen here] on the matter, Prasad said the trial was “the worst trial I have ever read…I don’t understand how a trial could be so poorly reported and be missing such basic information.”

The trial was funded by Array BioPharma, Merck (for sites outside the United States), ONO Pharmaceutical, and Pierre Fabre, and concluded that a combination of encorafenib, cetuximab, and binimetinib resulted in significantly longer overall survival and a higher response rate than standard therapy in patients with metastatic colorectal cancer with the BRAF V600E mutation.

In a news article The BMJ said a spokeswoman for the New England Journal of Medicine had told them that Prasad’s questions should be directed at the authors of the paper and not the journal.

The journal said they had also received a statement from the BEACON authors that said they “stand by the design and results of the BEACON CRC trial, which we believe will form the basis for a new standard of care for patients with BRAF V600E mutant mCRC [metastatic colorectal cancer] who typically have a very poor prognosis.”

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