Cardioprotection thread, page-531

Yes a bad call by Lederle to back mitoxantrone over bisantrene, but given the amount of effort they had put into fixing the formulation of bisantrene without success it was probably the right call. The original bisantrene formulation was just not viable in solid tumours and AML was far too small a market at the time to make commercialisation worthwhile.

The really crazy thing about this trial is it appears the randomisation was broken good and the sicker and harder to treat patients ended up in the bisantrene arm (I assume the doctors wanted to give the sicker patients bisantrene because it was less toxic). In the paper the investigators corrected for this imbalance in the statistical analysis and the HR favoured bisantrene. What they had ended up showing in the Phase 3 trial was that bisantrene was better than the standard of care doxorubicin for overall survival AND it is was significantly less toxic, but by the time these results came in Lederle had already pulled the plug on bisantrene. Really bad luck for Lederle, really good luck for Race.