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Sunday, March 06, 2011
Caris Life Sciences to Present on Biomarker Expression at the Society of Gynecologic Oncologists 2011 Annual Meeting on Women's Cancer
1 comment :
I wonder if they are going to invent another endpoint (i.e. a 30% increase in TTP over the most recent prior therapy) like was done on their previous presentation? That is, if Dr No gave the patient XYZ therapy and it provided a 3 day response, then CARIS genetic guided therapy needed only provide a 4 day response to show statistical significance. In the previous data set, the 106 patient accrued had a whopping response rate of 5.6% by intent to treat with an objective response rate in the group of fully tested and treated patients of 10%. I certainly hope there has been some improvement.
ReplyDelete
Using the patient as his/her own control using TTP/PFS as endpoint is a useful study design that could be used to assess predictive tests for drug selection when it is not possible to do a randomized trial or to provide a basis to start one. TTP/PFS inversion, ie longer TTP/PFS on treatment selected by test than the standard empirical treatment given just before would be a justified endpoint provided that TTP/PFS is accurately measured.
In other words, in their presentation at the American Assoication of Cancer Research meeting last year in Denver, Colorado, the objective response rate was 10%. Median overall survival for the 66 patients treated with assay-directed therapy was 9.7 months versus the overall survival for all 106 patients of 5 months (but this included the patients who had progressive disease and deteriorated before any treatment at all could be given).
The reason patients did not proceed to therapy was disease progression in 75%. Only 62% of all the accrued patients were treated. The drop out of 40 patients may have served to cull the most vigorous from the herd, introducing a bias for survival regardless of intervention.
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I wonder if they are going to invent another endpoint (i.e. a 30% increase in TTP over the most recent prior therapy) like was done on their previous presentation? That is, if Dr No gave the patient XYZ therapy and it provided a 3 day response, then CARIS genetic guided therapy needed only provide a 4 day response to show statistical significance. In the previous data set, the 106 patient accrued had a whopping response rate of 5.6% by intent to treat with an objective response rate in the group of fully tested and treated patients of 10%. I certainly hope there has been some improvement.
ReplyDeleteUsing the patient as his/her own control using TTP/PFS as endpoint is a useful study design that could be used to assess predictive tests for drug selection when it is not possible to do a randomized trial or to provide a basis to start one. TTP/PFS inversion, ie longer TTP/PFS on treatment selected by test than the standard empirical treatment given just before would be a justified endpoint provided that TTP/PFS is accurately measured.
In other words, in their presentation at the American Assoication of Cancer Research meeting last year in Denver, Colorado, the objective response rate was 10%. Median overall survival for the 66 patients treated with assay-directed therapy was 9.7 months versus the overall survival for all 106 patients of 5 months (but this included the patients who had progressive disease and deteriorated before any treatment at all could be given).
The reason patients did not proceed to therapy was disease progression in 75%. Only 62% of all the accrued patients were treated. The drop out of 40 patients may have served to cull the most vigorous from the herd, introducing a bias for survival regardless of intervention.