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Monday, 05/27/2013 11:52:45 AM

Monday, May 27, 2013 11:52:45 AM

Post# of 345976
The phase 1 HER2-negative breast cancer trial.
At last year's AACR annual meeting a poster was presented on this trial.
http://www.peregrineinc.com/images/stories/pdfs/aacr_2012_mbc_ist.pdf
At the time the "best response" results were given as:

CR 2
PR 1
SD 0
PD 2
not yet assessed 1

of the 5 patients assessed the ORR was 3/5, or 60%. Note the objective response rate = complete response (CR)
+ partial response (PR), it does not include stable disease (SD). Also note that this was the "best response"
observed at the time of assessment, and is not the best overall response determined when the trial has been completed.
Because of that, the "best repsonse" can change from the first assessment to later assessments.
This is shown in this table from the RECIST guidelines (v1.1)


Now the abstract from this year's ASCO annual meeting lists these as the "best response to date"

CR 1
PR 6
SD 1
PD 2
not yet assessed 4

so, all 14 patients have been enrolled, and 10 have been assessed at least once. This gives an ORR of 7/10 = 70%.
Note that one of the CR from the first assessment has become something else, but we can't be sure what (PR,SD, or PD).
This means that the cancer came back at the later assessment time.
It is interesting that 7/14 patients have triple-negative metastatic breast cancer. This is a
particularly hard type of MBC to treat so it will be of interest to see the final results for them.




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