An enormous dropout (LTFU) number in this trial would not be surprising.
1. Assuming that similar to the global breakdown, this trial had 40% lower risk patients who did not receive chemotherapy and 60% higher risk patients who did, we would have at the start about 320 of the 798 patients who were at low risk and did not receive chemotherapy and about 478 high risk, chemotherapy treated patients.
2. Assuming no dropouts, of those 320 low risk patients, 160 were treated with RT and received Multikine and 160 only received RT. Non received chemotherapy.
3. Of the 160 patients receiving Multikine and RT but no chemotherapy, 62.7% or about 100 were alive at 5 years and 37.3% or 60 were not.
4. Of the 160 patients receiving RT but no multikine or chemotherapy, 48.6% or about 78 were alive and 51.4% or 82 were not.
5. Apart from the estimate that 22 more patients survived in the multikine group than in the SOC group which is great, we should note that in just 40% of that trial we had already estimated 142 events (60+82=142).
6. Given a total of 298 events when the trial ended, we would assume that the remaining 156 fatalities (298-142=156) would originate from the 479 patients who received chemotherapy.
7. That over a 5 year period only 156 fatalities were recorded among 479 high risk patients (32.6%) is highly unrealistic.
That strongly suggests that while the percentages of survivors and events is correct, the number of patients staying on the trial
was closer to 550 rather than 798 because a large number of patients had dropped out. I am now guessing that we had no more than 550 legitimate patients remaining in the trial and that for the entire trial we had roughly a 55% event rate within the 5 years and that would add up approx to a total of 298 events.
I hope that the LTFU problem will be discussed during Thursday's Annual meeting.
