We are very close to a release about the CUP-trial results ("end of June"). Good things are expected.
Median PFS in CUP treated with CaP (=the controll arm) is 3-6 months. It was at least 16 months since the last patient was enrolled when the trial was stopped. STILL 22 of 89 patients had not been classified as progressed disease, i.e. that they had left PFS! A sensation is on its way, no doubt about it. The effects of CaP-treatment (= the control-arm) in CUP is well known. Normal would be 1-2 in PFS by that time in a CaP-arm containing 44/45 patients enrolled from April 2009 to December 2010. These figures do not vary very much. This is a sadly predictable disease.
In TOPOTARGET´S CUP-trial there was in April still at least 22 patients of 89 who could not be classified as having left PFS. That is a minimum of 24,7% - for the whole trial! However, we have to reduce this figure because of drop outs. We know through communication from the company that the number of these are ´normal´. That is to say ca 5 (indeed, some statements from the company can be interpreated as if non of these belonged among the 22!). That would leave us with 17 of 89 still in PFS, i e. 19% STILL IN PFS when the trial was stoped ca April 25 (my guess).
We have 44/45 patients in each arm, and in the CaP arm only 1-2 would normally still remain in PFS. Let´s double that to leave out all doubts and say that they are 4-5. Then we still have at least 12 of 44/45 left in PFS in the BelCaP-arm. That is at least 12/45 = 26.7% still in PFS.
One of the bigger previous trials with CaP (= the control-arm):
http://www.ncbi.nlm.nih.gov/pubmed/20164695
Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan
Phase III, 198 patients
Results includes:
"PCE and gemcitabine/irinotecan produced similar 2-year survival (15% vs. 18%), median survival (7.4 months vs. 8.5 months), median progression-free survival (3.3 months vs. 5.3 months), and response rate (18% vs. 18%)."
We have a PFS rate in TOPO´s CUP-trial that well will exceed the the 2-year survival rate in the trial above!!! Nothing like that has ever happened before in any of the many trials that has conducted in CUP. It has never even been close to something similar. In fact the PFS rate in this trial will probably exceed the 2 year survival rate in any of the other trials.
It is beyond doubt now that there are spectacular results on their way in this trial.
Something extraordinary good has taken place in the BelCaP-arm.
Sendt fra ProInvestor gruppen
27/6 2012 15:35 Nakskov 0
58699 Jeg synes det er tæt på, lige før, nu sker det, så er det nu..... Og alt det der hele tiden med Topo!
