Data Published at ASCO Finds Correlation Between ChemoFx(R) Assay and Significantly Improved Overall Survival in Ovarian Cancer Patients

Despite the fact that all patients had the same type of tumor, 88 percent of patients exhibited varying degrees of response to different [chemotherapy] agents when evaluated by the [ChemoFx®] cell-based test. The analysis also found that nearly two-thirds of patients’ tumors were more responsive to a treatment identified by ChemoFx, than to the treatment they actually received. Based on these results, a mathematical model was created to estimate survival had patients been treated with a drug that ChemoFx identified as more likely to result in a greater tumor response. The analysis found that median OS could be extended as much as 23 to 38 months.

Precision Therapeutics Inc. announced today that the ChemoFx(R) Assay, a cell-based test that examines the response of a specific patient’s tumor to various chemotherapies, correlates with significantly longer overall survival (OS) in patients with primary ovarian cancer. Patients who received a treatment determined by ChemoFx to lead to the best tumor response had an overall survival 1.4 times longer than those receiving a treatment shown by ChemoFx to be non-responsive.

Despite the fact that all patients had the same type of tumor, 88 percent of patients exhibited varying degrees of response to different agents when evaluated by the cell-based test. The analysis also found that nearly two-thirds of patients’ tumors were more responsive to a treatment identified by ChemoFx, than to the treatment they actually received. Based on these results, a mathematical model was created to estimate survival had patients been treated with a drug that ChemoFx identified as more likely to result in a greater tumor response. The analysis found that median OS could be extended as much as 23 to 38 months.

‘These overall survival data demonstrate that the responsiveness to treatment established by this sensitivity assay in the laboratory setting, may in fact translate into meaningful clinical outcomes for patients,’ said Thomas J. Herzog, MD, director of gynecologic oncology at the Columbia University Medical Center and lead investigator of the study. ‘If these results are confirmed in current ongoing trials, this will be a significant step towards establishing individualized treatment strategies for patients who will require chemotherapy.’

About the Study

Patients analyzed in the study had stage II-IV primary epithelial ovarian cancer that was tested by ChemoFx between 1997 and 2003, and received at least one course of chemotherapy. The study evaluated differences in OS between patients who received treatment that was deemed responsive, intermediate-responsive or non-responsive based on ChemoFx test results.

Of the 206 patients analyzed:

— Median OS of Assay non-responsive patients was 39.2 months

— Median OS of Assay intermediate-responsive patients was 62.5 months

— Median OS of Assay responsive patients was 80.4 months

When accounting for cancer stage and debulking — the reduction of tumor size due to surgery or radiation treatment — overall survival was significantly associated with the ChemoFx Assay and the cancer stage. In the model simulating improved survival if patients were treated with a therapy that caused a greater tumor response, median OS of patients treated with an Assay non-responsive drug could be improved from 39.2 to 62.5 months and median OS of patients treated with an Assay intermediate-responsive drug could be improved from 62.5 to 101.3 months.

‘People with cancer often require additional treatment after receiving the standard of care chemotherapy. ChemoFx Assay can provide valuable information that could spare the patient from unnecessary toxicity associated with a potentially ineffective treatment,’ said Sean McDonald, CEO Precision Therapeutics. ‘The goal of ChemoFx is to empower patients and physicians with additional diagnostic information to help determine the most appropriate course of therapy for each individual patient.’

This retrospective, multi-center analysis is a published abstract [“A chemoresponse assay and survival in primary ovarian cancer,” T. J. Herzog, et. al.; J Clin Oncol 26: 2008 (May 20 suppl; abstr 16522)] at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and is available at http://www.asco.org.

About ChemoFx(R)

ChemoFx is a decision support tool that measures a specific patient’s tumor response to various types, combinations and doses of chemotherapy selected by the patient’s physician. The laboratory test examines how many cancer cells are killed after exposure to treatment, using a patient’s living cancer cells that have been removed during a biopsy, aspiration or surgical procedure. ChemoFx can be used in primary, recurrent, and metastatic tumors.

ChemoFx can be tested in all solid tumor types, with ovarian and breast tumors being primarily tested. Other solid tumors most commonly tested include endometrial, colorectal, genitourinary, head and neck, lung, brain, pancreas, hepato-biliary.

About Precision Therapeutics

Precision Therapeutics is an oncology services company dedicated to the individualization of cancer therapy. Precision Therapeutics is a leader in the development and delivery of personalized treatment support tools that assist physicians and benefit cancer patients. For more information visit www.precisiontherapeutics.com, call 800-547-6165 or email info@ptilabs.com.”

[Quoted Source: “Data Published at ASCO Find Correlation Between ChemoFx(R) Assay and Significantly Improved Overall Survival in Patients With Ovarian Cancer – Analysis Reveals Overall Survival Could be Extended if Patients Receive the Most Effective Treatment Identified by ChemoFx,” Precision Therapeutics Press Release dated May 20, 2008.]

Comment: It is prudent for an ovarian cancer survivor to request the use of a chemoresponse assay (lab test) on any biopsied primary/metastatic ovarian cancer tumor tissue obtained at the time of initial diagnosis and/or recurrence. Given the likelihood of recurrence with respect to ovarian cancer diagnosed in late stages, a chemoresponse assay may prevent the use of ineffective chemotherapy in a situation where multiple lines of treatment become necessary.

Clinical Trial Information: For an open clinical trial involving the use of the ChemoFx® Assay, see “ChemoFx® Observational Study: A Non-Interventional, Longitudinal, Multi-Center Initiative Examining Outcomes Associated With the Use of the ChemoFx Assay® in Solid Tumor Malignancies” (currently recruiting ovarian cancer patients). Click here to see Precision Therapeutics Information regarding clinical trial testing of the ChemoFX® Assay.

One thought on “Data Published at ASCO Finds Correlation Between ChemoFx(R) Assay and Significantly Improved Overall Survival in Ovarian Cancer Patients

  1. Cellular and Genetic Tests Refine Cancer Treatments

    Thanks to advances in biology and genetics, upcoming and existing technologies for personalizing cancer diagnosis and drug treatments are very real, like biomarkers to identify which patients benefit the most.

    The key hurdle for these technologies is overcoming the pharmaceutical industry’s prevailing blockbuster economic model of the last twenty years. As one peruses the internet, they can see drug companies and so-called industry experts rush to suggest that personalized medicine and their blockbuster model are incompatible.

    Tests to identify individuals most likely to benefit from chemotherapy will certainly cut into their old and antiquated model. Having a bio-marker judge clinical efficacy of a particular drug would limit the drug’s “market” significantly. No drug company relishes turning over sizable pieces of profitable business through an act of altruism.

    Personalized medicine runs against their prevailing business model. Pharmaceutical companies and their industry spokespeople will try to buck the trend as long as they can, but many realize that personalized treatments are inevitable and are making their way into a new paradigm of cancer treatment.

    The pharmaceutical industry will need to transform itself as “business as usual” will no longer be good enough. The old pharma “blockbuster” business model is incompatible with personalized medicine. Diagnostics will almost certainly trump pharmaceutics.

    In 2006, Medicare officially recognized cell-based tests, such as the ChemoFX, as a special test category in Federal Regulations (42 CFR 414.510(b)(3), 71 FR 69705, 12/01/2006). They are now known as Oncologic In Vitro Chemoresponse Assays.

    As with any other laboratory tests in cancer medicine, the determination of the efficacy of chemoresponse assays is based on clinical correlations (comparisions of laboratory results with patient response). The standard of retrospective correlations between treatment outcomes and laboratory results is sufficient in the case of ALL laboratory tests. It is what established FDA-approval for the test kit.

    Two Medicare contractors (NHIC Medicare Services and Highmark Medicare Services) established reimbursement coverage policies for these tests, the same way that the genetic-based Oncotype DX assay is being covered.

    Medicare bills for chemoresponse testing, from any Medicare patients, anywhere in the United States, are billed through NHIC and Highmark Medicare Services because the test is conducted by approved laboratories in Southern California (Rational Therapeutics, Inc. and Weisenthal Cancer Group) and one in Pennsylvania (Precision Therapeutics, Inc.).

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