DR O’REILLY: This is probably the most practice-changing GI colorectal presentation from ASCO. So this was a large, 350-patient randomized Phase III trial in the adjuvant or Stage IV NED setting where patients were getting FOLFOX-based therapy. And there were 3 arms. The first arm, they were randomized to intravenous calcium and magnesium before and after each dose of treatment. In the second arm, they were randomized to placebo before and after. And then the third arm, they received calcium/magnesium before treatment and placebo afterwards.
And the goals of the study were to evaluate acute sensory neuropathy to look at chronic neuropathy, to look at dosing of oxaliplatin and to look at side effects of treatment. And the bottom line was very clear, despite some data preceding this, that suggested that there could be a benefit. There was no benefit in terms of the impact or duration of acute sensory neuropathy in terms of colds, throat discomfort, all of the things that patients commonly talk to us about. And there was no impact in terms of the time to cumulative dose-limiting neuropathy, no change in that. All of the curves were directly overlapping. So the clear implication from this study is that we should not be using calcium/magnesium as a neuroprotectant strategy with oxaliplatin-based therapy. This was in the adjuvant, but obviously the implications are across the disease spectrum.
DR LOVE: I actually kind of — what caught me by surprise is that so many people are using it. I wasn’t really aware. It’s kind of been under the radar for a while. Then this paper came out and we started asking people, “Are you using it?” We heard a lot of people say, “Yes, I was, and now I’m not.”
DR HECHT: Yes.
DR LOVE: Just real quick, is that your story, Charlie?
DR FUCHS: I had used it selectively, but I’m not using it at all now.
DR LOVE: Johanna?
DR BENDELL: Was using it, but now I’m not.
DR LOVE: Philip?
DR PHILIP: In our institution, we never used it as a routine.
DR LOVE: Never used it. Randy?
DR HECHT: See, we always used it. And in fact, we came back when it was originally presented and, like, took people off of it. It made the nurses happy, because even though calcium/magnesium is not that expensive, there is infusion. But there’s also chair time. Which is expensive. It’s nurse time. So we stopped it the next day, basically, after the original presentation.
DR LOVE: Rich?
DR GOLDBERG: So I had used it selectively. And my experience with it was not very favorable. The comment I would make is it became an urban myth that this was effective based on Gamelin’s original retrospective analysis. And I have to give the NCCTG credit for finally mounting a definitive trial about this. There had been all kinds of anecdotal and small trials that were used by proponents to advocate for this. And now we know that they were wrong.