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by blithedale 2104 days ago
I'm not convinced the 2/3 dropout rate of the FMD didn't simply select for people with less aggressive tumors, given that the Intention-To-Treat analysis found no difference in response rate, and that this paper is telling a nice story that actually happens to reverse cause and effect.

Basically, this?

   HAS AGGRESSIVE TUMOR ---> CANNOT DO THE FMD

   HAS SLOW-GROWING TUMOR ---> ABLE TO MAINTAIN FMD
Since you're researcher in this field and I'm just a weirdo who likes watching scientists argue on Twitter, I'll ask: Anything you can see in the paper that would give a clearer picture regarding possible bias that might have snuck in?
2 comments

That could very well be a possibility and something that researchers need to address if they wish to investigate this effect a bit further. We can make some educated guesses based on the supplemental table 3. Looking at the staging, grading, tumortype and the hormone receptor status, there don't seem to be any significant differences between the compliant and non-compliant groups. We know that those are the most important factors in assessing how aggressive a breast tumor is, with distinct treatment options and overall survival. So based on this information, I'm inclined to say the cause/effect is not reversed.

Of course, there could be some factors determining aggressiveness and response to chemotherapy that we do not know yet. Unfortunately I'm not in regular patient contact so can't say a whole lot about typical side effect profiles of chemotherapy, but I've heard some anecdotal evidence that for patients treated with immunotherapy, the more severe the side effects, the better the response.

Thanks for clarifying comments here, much appreciated.

I have to think my initial comment was overly harsh as well, given Supplement 3.

I think all I can say is that it may be possible for this issue to affect their data once they have OS stats accumulated in five years, but it was unlikely to do anything to yield differences in adherence with these kinds of patients over this kind of follow-up length.

"The main reason for non-adherence to the FMD was dislike of distinct components of the diet, perhaps induced by chemotherapy [...] The FMD is a 4-day plant-based low amino-acid substitution diet, consisting of soups, broths, liquids and tea"

Occam's razor, patients couldn't stick with the diet.