The LuPIN trial is getting interesting because it's now been...

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    The LuPIN trial is getting interesting because it's now been running long enough to deliver actual results from a reasonable number of participants, as opposed to projections from a small number. Having said that, I've reviewed last year's projections to get a handle on them.Last year's report didn't explicitly separate the performance of the 400mg and 800mg Cohorts - except for a graph of "best PSA responses", so very loosely:

    400mg Cohort 1
    4 of the 8 had low (2 negative) responses (50%)
    4 of the 8 had good responses (50%)
    800mg Cohort 2
    4 of the 24 had low (1 negative outlier) responses (17%)
    6 of the 24 had medium responses (25%)
    14 of the 24 had good responses (58%)

    Nothing more than a ball park split, but at least given the timeframes over which the biggest PSA responses will occur, I'm comparing cohort 1 & 2 apples. Collectively, the 800mg dosages seem to edge towards higher best PSA responses.

    Secondly, it seems that extra months do strongly correspond to the "best PSA response" ranking. By working backwards it's possible to work out details on the 50% of best responders in Cohort 1. Given the length of the trial and recruited times I believe it's certain that of these 4 men:
    1 survived to 23 mths, 1 to 25 mths and 1 was still alive at the trial reporting date, 26.2 mths. The 4th person is likely the 17.1 month survivor given the look of the K-M curve (but timing wise this could be a Cohort 2 trialist).

    Assuming he was from the first cohort, his 17.1 months was the 5th best outcome of the 8 man cohort. The K-M survival curve has his outcome as the projected median of all 32 trialists, probably because the projection is allowing for the better average "best PSA response" of Cohort 2 noted above - pushing the projected outcome curve to the right. Probably not allowed for is the 1 man of cohort 1 who was still alive and potentially adding months.

    A year on and GK sounds confident. I'm thinking that he thinks the 400/800mg dosages were cautious, perhaps overly weighted towards safety that therapeutic response. At 1,200mg we are asking the question.


 
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