This doesn’t directly relate to lung cancer, but in a prior post I described a trial of the vitamin D analog calcitriol (Asentar) with taxotere for treating advanced NSCLC.  Although it has been very unclear whether there might be any future for this agent in lung cancer, I and many others were pretty impressed by the results of a randomized phase II trial for metastatic prostate cancer, called ASCENT, with 250 patients who were randomized to taxotere and prednisone with or without calcitriol.  This study actually showed an improvement in overall survival in the recipients of calcitriol with chemo, but it wasn’t a huge trial.  A larger phase III randomized study with the same design (called ASCENT-2, cleverly enough) has been ongoing in prostate cancer.   Presumably, if this one came out as well,  it would look good for it to be approved by FDA.

   While we don’t have any real results yet, we know from a press release that the trial was stopped early due to an unexpected excess of deaths on the arm that received calcitriol with chemo.  This led the Data Safety Monitoring Board to close the trial.  This doesn’t have any immediate implications for lung cancer, except that now I’d really doubt we’ll see the concept I described in my post followed with a larger study in lung cancer.  And it’s another example of how an early small trial can look really promising, but the new treatment not only be of no significant benefit but also potentially be harmful.  I haven’t been recommending high dose vitamin D for my patients, but it’s a cautionary point that there might be detrimental effects from high doses of certain vitamins (potentially from the interaction with chemo but wouldn’t occur without concurrent chemo).  I don’t have any more details, but I’ll let you know if we learn more.