Any info on Precision Therapeutics?

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Anonymous said:
Yes, I was serious. Thanks for that information.

These labs tests and studies you cite do not conclude the direction of patient therapy, that is left to the clinician. These tests and data you refer to speak to the feasibility of the clinical implication of the study. It is up to the clinician to take all aspects of the patient information and make a clinical judgment on therapy. Can these lab tests help guide therapy? Absolutely. Do they replace the judgment of the clinician? Absolutely not.

Every one of the articles listed on the PTI website, speak to the feasibility of the CSRA being used in a clinical setting to help guide therapy.

The functional aspect of the cell is just another piece of information to help the clinician. There is not a lab test available that is 100% accurate, and therefore there is no lab test that can be used to direct therapy, only help guide it.
Click to expand...

You wrote, "Please provide some data on a laboratory test, (any lab test), that involves the patient's therapy being directed by the results of the particular laboratory test you choose to reference."

Linked was one study where they directed the patient therapy with or without cisplatin - based on expression of ERCC1 - in one arm vs. standard docetaxel/cisplatin in the other arm. That is one example that meets the criteria of what you requested. I don't suggest that these tests are used solely to direct therapy without clinician input in the clinic. However, in this particular study setting, and many others involving Her2, KRAS, and EGFR, the therapy IS directed as a result of the lab test. It was necessary in order to prove the value of the test.

PTI has yet to publish data where the patient therapy is directed or outcome effected by the assay and thus there is much to question in regards to the impact on patient outcomes. PTI even has a propective trial (PT-301) currently enrolling patients but according to the clinicaltrials.gov website, "The study is not randomized and the results of the assay will not be used in the decision process for which agent to select for treatment, but are made available to the treating physician upon further progression."

I firmly believe the only thing that will answer things once and for all is a trial that involves assay directed therapy. If/when you have it, no one can argue with that and it will put to rest much uncertainty.
 






Anonymous said:
You wrote, "Please provide some data on a laboratory test, (any lab test), that involves the patient's therapy being directed by the results of the particular laboratory test you choose to reference."

Linked was one study where they directed the patient therapy with or without cisplatin - based on expression of ERCC1 - in one arm vs. standard docetaxel/cisplatin in the other arm. That is one example that meets the criteria of what you requested. I don't suggest that these tests are used solely to direct therapy without clinician input in the clinic. However, in this particular study setting, and many others involving Her2, KRAS, and EGFR, the therapy IS directed as a result of the lab test. It was necessary in order to prove the value of the test.

PTI has yet to publish data where the patient therapy is directed or outcome effected by the assay and thus there is much to question in regards to the impact on patient outcomes. PTI even has a propective trial (PT-301) currently enrolling patients but according to the clinicaltrials.gov website, "The study is not randomized and the results of the assay will not be used in the decision process for which agent to select for treatment, but are made available to the treating physician upon further progression."

I firmly believe the only thing that will answer things once and for all is a trial that involves assay directed therapy. If/when you have it, no one can argue with that and it will put to rest much uncertainty.
Click to expand...

You make a very good point. The ERCC1 study you reference is a good one, no doubt, but again it is just a guide. Cisplatin is a highly toxic chemo, and is especially rough on cardiac tissue. Many patients cannot tolerate this platin based regimen, so again, this test is just a guide.

The study you reference clearly states:

The design of the study by Cobo et al10 also merits discussion. The underlying hypothesis is that ERCC1 customization should improve clinical outcome (response rate and survival). This should be achieved by offering cisplatin-based therapy to ERCC1-negative patients and an active platin-free regimen to ERCC1-positive patients. The choice of docetaxel in combination with gemcitabine for ERCC1-positive patients is debatable. Indeed, although docetaxel is a tubulin-interacting agent, gemcitabine is an antimetabolite that will have an influence on the pool of nucleotides available for DNA repair, and thus may interact with the NER pathway. Given that the treatment is different in the high and low genotypic groups, the final result of the present study (either positive or negative) could either be linked to the predictive value of ERCC1 or simply to intrinsic differences related to the chemotherapy regimens selected.

It is noteworthy that the authors did not reveal the predictive value of ERCC1 in the control arm in this study. The best way to control for the predictive value of ERCC1 would have been a retrospective analysis of ERCC1 expression in the noncustomized control arm, in which all patients were treated with the same cisplatin-based regimen. Finally, the design of the trial allowed for ERCC1 evaluation in any tumor tissue available. ERCC1 was evaluated in metastatic lesions in only 24% of the patients, whereas 92% of them had stage IV disease. Differential protein expression of specific biomarkers between primary and metastatic lesions has been reported in various tumors including NSCLC.11,12 In colon cancer, thymidylate synthase evaluated in metastatic lesions was shown to be more predictive than thymidylate synthase measured in the primary tumor.11 Other factors may explain interindividual ERCC1 variation, such as the smoking status (the nucleotide excision pathway is involved in tobacco-related adduct clearance), age, or the histologic subtype, but no correlation was provided in the study by Cobo et al.10.

I will agree that KRAS, HER2 & EGFR all have good, solid studies behind them. However, they are not all prospective randomized trials, and are still used every day to help clinicians guide therapy in their patients.

I find it interesting that you fail to mention ER & PR, which is standard of care today, and when paired with HER2, helps identify triple negative breast cancer patients. ER/PR has never undergone a prospective randomized trial, yet this lab test is standard of care today, and helped millions over the years.

Prospective randomized trials should be used when developing pharma agents, until a better way can be developed, there is no doubt.

The standard used to judge the utility of laboratory and radiographic tests has always been "acceptable accuracy of clinical correlations" and "clinical utility." Demanding (for demanding sake) proof of "efficacy," as opposed to proof of "accuracy," is completely unprecedented for laboratory tests in cancer (you just don't make up another criterion for the sake of making it up). Why do you think that is?

My opinion: ASCO states that cell culture assays should not be used outside the confines of a clinical trial setting. The same people who maintain that assay-directed therapy should not be used until proven in prospective randomized clinical trials, are the same people whose entire careers are utterly dependent upon mega-trials funded by pharmaceutical companies (that, plus fees from speeches they give for these companies), are the same people who control the clinical trials system, the grant review study sections, and the journal editorial boards. Every time credible researches have proposed such a study on assay driven testing, they have found no support from ASCO, NCI, or any other organization. Why sould they purposely cut into the bottom line? (Again, my opinion entirely.)

Cancer is a disease which has always been managed on the basis of "best evidence" and not on the basis of "conclusive evidence," which is lacking in virtually all situations in clinical oncology, including those situations in which clinical trials to identify the best treatment for the average patient have been performed and published and meta-analyzed.

Retrospective trials are a better cross section of a patient poplulation, as the patient population is not "hand-picked." These types of studies are the most effective way, (financially and clinically), to evaluate clinical utility in patient populations with regards to laboratory testing. Laboratory testing does not direct therapy, they help guide therapy.
 






Thank you for engaging in civil discussion. I really enjoy these types of discussions. I do respect your opinion, I just don't agree with it. Which I know goes both ways, the not agreeing part anyway, I have no idea if you respect me or not.
 


















This company is an absolute joke. While working here I felt as though I was selling my soul. Most management had no idea what they were doing and were not even qualified to be a GM at a McDonalds. My manager in particular couldnt even stay employed at her previous jobs, yet somehow Precision hired her. How do reps hit their number? By cutting viable cancer tumors into pieces too small to test, by turning in benign specimens, by paying labs to send in specimens without surgeon or patient authorization...just the beginning of the mess. And the results are an absolute joke as well, most say nothing. I feel embarrassed to have even sold this. Most of the reps still there are either doing something illegal or just trying to buy time before their next jobs. Hopefully this company will be investigated and all truth will be out. Avoid working here or using this product at all costs.
 






Anonymous said:
This company is an absolute joke. While working here I felt as though I was selling my soul. Most management had no idea what they were doing and were not even qualified to be a GM at a McDonalds. My manager in particular couldnt even stay employed at her previous jobs, yet somehow Precision hired her. How do reps hit their number? By cutting viable cancer tumors into pieces too small to test, by turning in benign specimens, by paying labs to send in specimens without surgeon or patient authorization...just the beginning of the mess. And the results are an absolute joke as well, most say nothing. I feel embarrassed to have even sold this. Most of the reps still there are either doing something illegal or just trying to buy time before their next jobs. Hopefully this company will be investigated and all truth will be out. Avoid working here or using this product at all costs.
Click to expand...

Well said, I could not agree more. I don't think the product is the real problem here. It is what it is... enough said. The problem is the management and what they have asked us to do over the years to hit our numbers, how they have asked us to manipulate the comp plan so that they can make more money, how certain managers have asked us to send in benign specs just so the company can hit it's number, how we continue to count duplicate specs, how we constantly violate the 14 day rule when a doctor sends in an aof too early by asking them if they "really" meant to sign it, how managers asks us to get anyone in the office to sign the aof on behalf of the doctor, etc...

I'm just shocked that our ceo and vp are this disengaged. How can they not see this stuff? Turnover is higher than it has ever been and morale is crap. Too bad all everyone does is bitch about this company on the cafepharma boards, but when marshall gets on a conference call with each region everyone tells him how much they love working here and how great everything is, instead of telling him how you really feel. Will Precision last? Not sure, but the way they're going they'll be lucky to make it another few years...
 






Anonymous said:
You make a very good point. The ERCC1 study you reference is a good one, no doubt, but again it is just a guide. Cisplatin is a highly toxic chemo, and is especially rough on cardiac tissue. Many patients cannot tolerate this platin based regimen, so again, this test is just a guide.

The study you reference clearly states:

The design of the study by Cobo et al10 also merits discussion. The underlying hypothesis is that ERCC1 customization should improve clinical outcome (response rate and survival). This should be achieved by offering cisplatin-based therapy to ERCC1-negative patients and an active platin-free regimen to ERCC1-positive patients. The choice of docetaxel in combination with gemcitabine for ERCC1-positive patients is debatable. Indeed, although docetaxel is a tubulin-interacting agent, gemcitabine is an antimetabolite that will have an influence on the pool of nucleotides available for DNA repair, and thus may interact with the NER pathway. Given that the treatment is different in the high and low genotypic groups, the final result of the present study (either positive or negative) could either be linked to the predictive value of ERCC1 or simply to intrinsic differences related to the chemotherapy regimens selected.

It is noteworthy that the authors did not reveal the predictive value of ERCC1 in the control arm in this study. The best way to control for the predictive value of ERCC1 would have been a retrospective analysis of ERCC1 expression in the noncustomized control arm, in which all patients were treated with the same cisplatin-based regimen. Finally, the design of the trial allowed for ERCC1 evaluation in any tumor tissue available. ERCC1 was evaluated in metastatic lesions in only 24% of the patients, whereas 92% of them had stage IV disease. Differential protein expression of specific biomarkers between primary and metastatic lesions has been reported in various tumors including NSCLC.11,12 In colon cancer, thymidylate synthase evaluated in metastatic lesions was shown to be more predictive than thymidylate synthase measured in the primary tumor.11 Other factors may explain interindividual ERCC1 variation, such as the smoking status (the nucleotide excision pathway is involved in tobacco-related adduct clearance), age, or the histologic subtype, but no correlation was provided in the study by Cobo et al.10.

I will agree that KRAS, HER2 & EGFR all have good, solid studies behind them. However, they are not all prospective randomized trials, and are still used every day to help clinicians guide therapy in their patients.

I find it interesting that you fail to mention ER & PR, which is standard of care today, and when paired with HER2, helps identify triple negative breast cancer patients. ER/PR has never undergone a prospective randomized trial, yet this lab test is standard of care today, and helped millions over the years.

Prospective randomized trials should be used when developing pharma agents, until a better way can be developed, there is no doubt.

The standard used to judge the utility of laboratory and radiographic tests has always been "acceptable accuracy of clinical correlations" and "clinical utility." Demanding (for demanding sake) proof of "efficacy," as opposed to proof of "accuracy," is completely unprecedented for laboratory tests in cancer (you just don't make up another criterion for the sake of making it up). Why do you think that is?

My opinion: ASCO states that cell culture assays should not be used outside the confines of a clinical trial setting. The same people who maintain that assay-directed therapy should not be used until proven in prospective randomized clinical trials, are the same people whose entire careers are utterly dependent upon mega-trials funded by pharmaceutical companies (that, plus fees from speeches they give for these companies), are the same people who control the clinical trials system, the grant review study sections, and the journal editorial boards. Every time credible researches have proposed such a study on assay driven testing, they have found no support from ASCO, NCI, or any other organization. Why sould they purposely cut into the bottom line? (Again, my opinion entirely.)

Cancer is a disease which has always been managed on the basis of "best evidence" and not on the basis of "conclusive evidence," which is lacking in virtually all situations in clinical oncology, including those situations in which clinical trials to identify the best treatment for the average patient have been performed and published and meta-analyzed.

Retrospective trials are a better cross section of a patient poplulation, as the patient population is not "hand-picked." These types of studies are the most effective way, (financially and clinically), to evaluate clinical utility in patient populations with regards to laboratory testing. Laboratory testing does not direct therapy, they help guide therapy.
Click to expand...

Since you did not touch on this main point, do you disagree that PTI needs data where therapy selection is based on the assay results?
 






Anonymous said:
This company is an absolute joke. While working here I felt as though I was selling my soul. Most management had no idea what they were doing and were not even qualified to be a GM at a McDonalds. My manager in particular couldnt even stay employed at her previous jobs, yet somehow Precision hired her. How do reps hit their number? By cutting viable cancer tumors into pieces too small to test, by turning in benign specimens, by paying labs to send in specimens without surgeon or patient authorization...just the beginning of the mess. And the results are an absolute joke as well, most say nothing. I feel embarrassed to have even sold this. Most of the reps still there are either doing something illegal or just trying to buy time before their next jobs. Hopefully this company will be investigated and all truth will be out. Avoid working here or using this product at all costs.
Click to expand...

Loser, compromisies own principles, and blames someone else.
 






Anonymous said:
Well said, I could not agree more. I don't think the product is the real problem here. It is what it is... enough said. The problem is the management and what they have asked us to do over the years to hit our numbers, how they have asked us to manipulate the comp plan so that they can make more money, how certain managers have asked us to send in benign specs just so the company can hit it's number, how we continue to count duplicate specs, how we constantly violate the 14 day rule when a doctor sends in an aof too early by asking them if they "really" meant to sign it, how managers asks us to get anyone in the office to sign the aof on behalf of the doctor, etc...

I'm just shocked that our ceo and vp are this disengaged. How can they not see this stuff? Turnover is higher than it has ever been and morale is crap. Too bad all everyone does is bitch about this company on the cafepharma boards, but when marshall gets on a conference call with each region everyone tells him how much they love working here and how great everything is, instead of telling him how you really feel. Will Precision last? Not sure, but the way they're going they'll be lucky to make it another few years...
Click to expand...

Loser, probably made money hand-over-fist the past few years, and instead of being bold and making a difference, was a coward and points at others as the one's to blame.
 






Anonymous said:
Since you did not touch on this main point, do you disagree that PTI needs data where therapy selection is based on the assay results?
Click to expand...

The doctor chooses the drugs they want to see in the testing process, either by creating a custom panel, or a standard panel. Standard panels contain only NCCN guideline drugs for that particular tumor type.

If you're looking for the magic bullet, and eliminate the need for an oncologist's clinical judgment, then yes this kind of a study is necessary.

If you realize that there will never be a lab test that replaces the clinical judgment of a physician, (at least in our lifetime), then this kind of study is not necessary.

I believe it's up to the clinical judgment of the physician, and I've been very clear on this.

I would say that proving accuracy of the assay should be, and is, a more important focus.
 






Anonymous said:
Loser, probably made money hand-over-fist the past few years, and instead of being bold and making a difference, was a coward and points at others as the one's to blame.
Click to expand...

You're right, I don't step up because I see what happens to people who do at this company. They get fired/run out for challenging the current regime. I wouldn't call me a loser for that.
 






Anonymous said:
You're right, I don't step up because I see what happens to people who do at this company. They get fired/run out for challenging the current regime. I wouldn't call me a loser for that.
Click to expand...

However, you did say that you've been here for years, I'm sure you've made some pretty good coin while on board, and have chosen to stick around, despite your complaints.

You're either part of the solution, or part of the problem.
 






Anonymous said:
However, you did say that you've been here for years, I'm sure you've made some pretty good coin while on board, and have chosen to stick around, despite your complaints.

You're either part of the solution, or part of the problem.
Click to expand...

Yes, but I'm definitely looking to leave. The real money is drying up fast here and I'm tired of bringing in so many specs just to chase a number. Thank god we're not paid on aofs anymore or I would be screwed. I'm at the point now where physician friends of mine send everything and cancel everything just to help me out... How long can that sustain itself? I know I'm not the only one who feels this way. I'm not sure when or where it happened, but the company definitely took a wrong turn somewhere along the way.
 






Anonymous said:
The doctor chooses the drugs they want to see in the testing process, either by creating a custom panel, or a standard panel. Standard panels contain only NCCN guideline drugs for that particular tumor type.

If you're looking for the magic bullet, and eliminate the need for an oncologist's clinical judgment, then yes this kind of a study is necessary.

If you realize that there will never be a lab test that replaces the clinical judgment of a physician, (at least in our lifetime), then this kind of study is not necessary.

I believe it's up to the clinical judgment of the physician, and I've been very clear on this.

I would say that proving accuracy of the assay should be, and is, a more important focus.
Click to expand...

I would say proving the assay works at all should be the most important focus
 












Anonymous said:
Yes, but I'm definitely looking to leave. The real money is drying up fast here and I'm tired of bringing in so many specs just to chase a number. Thank god we're not paid on aofs anymore or I would be screwed. I'm at the point now where physician friends of mine send everything and cancel everything just to help me out... How long can that sustain itself? I know I'm not the only one who feels this way. I'm not sure when or where it happened, but the company definitely took a wrong turn somewhere along the way.
Click to expand...

I know! It was hiring people like you, who are more interested in lining their pockets then helping the cancer patient. If you have any shred of integrity left in your body, you'll send your resignation into HR tomorrow.

Loser.
 






Anonymous said:
I know! It was hiring people like you, who are more interested in lining their pockets then helping the cancer patient. If you have any shred of integrity left in your body, you'll send your resignation into HR tomorrow.

Loser.
Click to expand...

If all the people at PTI who didnt have the best interest of the patient in mind sent in their resignation tomorrow, you wouldn't have a manager, regional VP, VP of sales, or CEO. It isn't and never has been a rep problem. It starts at the top and the shit rolls downhill. Have you not figured that out yet? If you are honest with yourself, I know you have
 






Anonymous said:
The doctor chooses the drugs they want to see in the testing process, either by creating a custom panel, or a standard panel. Standard panels contain only NCCN guideline drugs for that particular tumor type.

If you're looking for the magic bullet, and eliminate the need for an oncologist's clinical judgment, then yes this kind of a study is necessary.

If you realize that there will never be a lab test that replaces the clinical judgment of a physician, (at least in our lifetime), then this kind of study is not necessary.

I believe it's up to the clinical judgment of the physician, and I've been very clear on this.

I would say that proving accuracy of the assay should be, and is, a more important focus.
Click to expand...

Do you not realize there will always be a need for clinical judgment. The oncologist is looking for information that will help with treatment decisions not a one size fits all test. The PTI test may be good information but is not proven. By running an assay and saying tumors respond differently is pretty easy and any of us could do this. All they need to show is that the test is accurate. None of the studies show that. the retrospective studies it does have doesn't prove that it works. I really don't know what is proves beside that platinum resistent patients have the odds against them(which all providers know). Therapy was never directed to show that if platnium resistant patients would beneift from the assay. Why does PTI offer combination therapy when they have not been validated. Sounds like shady science. yes it can be used as a reference. Would you want your Dr. or provider to use something that has bad information on you or a loved one. There is no such thing as a magic bullet in cancer therapy. You would know that these cells change and this is the reason for the cancer. Fire the 2nd grader who colors your graphs and have some evidence behind the test. Using other assay's in a cell line and saying yours is the same is a ridiculous claim. This company is all about the money and trying to get sold fast. the end of the rope is near. You can take a dump in one hand and wish in the other and see what fills up first.
 






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