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Monday, May 03, 2021 4:16:29 PM
Unfortunately the paper you reference in your post, “Rapid Early Tumor Progression is Prognostic in Glioblastoma Patients”, is behind a pay wall so isn’t fully available for most of us to review.
https://pubmed.ncbi.nlm.nih.gov/30973372/
One should note, however, that the snapshot in the link you provided indicated that it involved a total of 87 patients, 52% of which were (rapid early progressors) REP. That means the sample that you cite for comparison of the mOS of the unmethylated and methylated (19.6 and 34.7) is for a fairly small sampling of only 42 patients. And because of the pay wall, the link you provided prevents us from seeing what was the entry criteria for this group.
So while the consistence between the medians of these 42 methylated and unmethylated GBM patients is similar to the blended medians of the DCVax-L trial for methylated and unmethylated, it’s also a small sample without any other comparable criteria to show other than the meth status and that these patients had GBM.
Additionally, while most of us agree that medians are helpful as a comparative measure, you know full well that medians are not what the DCVax-L trial will be measuring, but rather the entire measure of the treatment arm’s overall survival, and of course, as it compares to the entire measure of overall survival of control arms in other contemporaneous, AND COMPARABLE trials.
And while you may find this type of ECT comparison objectionable, it appears that the SAB, the steering committee, the multitudes of primary investigators, Northwest management are all prepared to utilize them to file BLAs with the RAs, despite your objection.
So I’m sorry that while you may find a 25% chance of living five years or longer a meaningless metric, I am certain there are many neurosurgeons, neuro-oncologists, and GBM patients who will not agree with you.
The diagnosis of GBM offers an extremely and consistently poor prognosis (as you know), and there is a myriad of very qualified KOLs that seem to think the regulatory agencies are willing to consider this ECT comparison. And that is ultimately what counts, and not what simply doesn’t comport for you in particular.
https://pubmed.ncbi.nlm.nih.gov/30973372/
One should note, however, that the snapshot in the link you provided indicated that it involved a total of 87 patients, 52% of which were (rapid early progressors) REP. That means the sample that you cite for comparison of the mOS of the unmethylated and methylated (19.6 and 34.7) is for a fairly small sampling of only 42 patients. And because of the pay wall, the link you provided prevents us from seeing what was the entry criteria for this group.
So while the consistence between the medians of these 42 methylated and unmethylated GBM patients is similar to the blended medians of the DCVax-L trial for methylated and unmethylated, it’s also a small sample without any other comparable criteria to show other than the meth status and that these patients had GBM.
Additionally, while most of us agree that medians are helpful as a comparative measure, you know full well that medians are not what the DCVax-L trial will be measuring, but rather the entire measure of the treatment arm’s overall survival, and of course, as it compares to the entire measure of overall survival of control arms in other contemporaneous, AND COMPARABLE trials.
And while you may find this type of ECT comparison objectionable, it appears that the SAB, the steering committee, the multitudes of primary investigators, Northwest management are all prepared to utilize them to file BLAs with the RAs, despite your objection.
So I’m sorry that while you may find a 25% chance of living five years or longer a meaningless metric, I am certain there are many neurosurgeons, neuro-oncologists, and GBM patients who will not agree with you.
The diagnosis of GBM offers an extremely and consistently poor prognosis (as you know), and there is a myriad of very qualified KOLs that seem to think the regulatory agencies are willing to consider this ECT comparison. And that is ultimately what counts, and not what simply doesn’t comport for you in particular.
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