DR GARCIA-MANERO: We helped develop decitabine, and we have worked quite a bit of azacitidine. The bottom line is that there’s only 1 trial with really survival data on a Phase III type of context, and that’s azacitidine.

So sometimes I think that I can judge what the taste of the community is because MD Anderson is a pure referral center — we don't really have an internal — maybe 0.1 % of referrals come from the house — and I can tell that in the front-line setting — I don’t know what Harry thinks about — aza has become the standard of care. And it’s based on the survival data. Both drugs are approved. In my opinion, probably they are equivalent, but one has, like, hardcore survival data. And it’s hard not to use in the front line the other agent, even if you like it very much, without that data.

DR ERBA: I agree. And I appreciate how you said that, especially coming from MD Anderson, I mean, where decitabine was developed. And it’s an incredibly effective drug. The issue is, for this patient, okay, you have a patient with — I didn’t do the calculation, but I’m going to say this is high-risk disease, and you’re trying to give him something that has a proven survival benefit. And the only study that has shown a proven survival benefit is azacitidine.

Now, we all understand, though, that the decitabine studies were flawed. The largest Phase III studies in decitabine did not use the MD Anderson dosing regimen. They used the older regimen of a 3-hour infusion every 8 hours for 3 days, a little bit more myelosuppressive, 6-week cycles there. And probably the biggest flaw of all those studies is they didn’t allow maintenance. And that was a real shot in the foot.

And so I agree that the drugs are probably equivalent, and based on that some people use decitabine because it’s 5 days instead of 7 days. And in this patient, I would definitely use the 7-day regimen. I would not use 5 days because there’s no data in these higher-risk patients.

But you have to go where the data is. The data shows a survival benefit for azacitidine. And we do remember that in that conventional care study, that study comparing aza with conventional care, a proportion of the patients did receive 3&7, but this group was too small to make any comparison of survival between 3&7 and azacitidine. They were all lumped together.

Important clinical issues in the management of MDS

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