At the end of the SMM abstract presented at ASH 2009 (see previous post), the authors write about a manageable and acceptable toxicity profile. I would like to take a closer look at this statement today. Let’s see. Many of these smoldering patients suffered from G3 adverse events…but what exactly does G3 mean?

Well, it just so happens that a fabulous blog reader (merci!) sent me a link to a grade toxicity chart that can help us understand what all these various levels (G1, G2, G3 and G4) mean: http://tinyurl.com/yfohksl

However, based on the way the ASH abstract is worded, I found it very difficult to figure out exactly how many patients experienced side effects. I am still not sure if I have counted them correctly, since there could be some overlap between the groups.

Well, let’s try to go through the abstract carefully: 

• 7 patients experienced G3 side effects, such as G3 asthenia, which, incidentally, means that they were not able to work (=normal activity reduced by 50%)…
• 5 patients had severe (=G3) dexamethasone or lenalidomide-related symptoms. Of these, 3 patients developed gastrointestinal bleeding, glaucoma and infections from dexamethasone, the other 2 had infections from lenalidomide (no details provided). Since these patients had different G3 symptoms from the above-mentioned 7 patients, I presume that they are not the same patients. No overlap. Presumably.
• 4 patients had to reduce their dose of lenalidomide because of side effects such as fatigue, diarrhea and gastrointestinal bleeding. I don’t think this number includes the two patients who developed G3 infections (see previous point), since the infections experienced in this group do not appear to be so severe…Not super clear, though.
• 2 patients left the study at their own request: they were probably among the above-mentioned G3 sufferers. Again, this is not clearly stated. But let’s say that that is the case…I won’t include them in my head count.

Boy, what a sloppy bit of writing. I am NOT impressed!

Anyway, trying to add all this up…it appears to me that the number of patients who suffered from a variety of side effects, some serious, some not so serious, is a whopping 16 (7+5+4). Hmmm, I don’t suppose anyone could help me figure this out? Or is it impossible, given the hazy details provided in the abstract? It is, most likely, the latter case…

Well, what is clear is that the side effects experienced by 16 patients or even 14 out of a total of 40 CANNOT be ignored. 

Manageable and acceptable…for whom???!!!