PITTSBURGH -- (BUSINESS WIRE) -- Precision Therapeutics announced today that findings from a clinical study supporting performance of the ChemoFx® drug response marker as a predictive marker have been released by British Journal of Cancer, an elite professional medical journal of Cancer Research UK. This key publication was developed in cooperation with physicians and researchers from the Mayo Clinic, MD Anderson Cancer Center, The Western Pennsylvania Hospital and Washington University School of Medicine, and answers the important clinical question of whether ChemoFx is predictive of treatment-specific outcomes in ovarian cancer patients.
The manuscript, Evaluation of a Chemoresponse Assay as a Predictive Marker in the Treatment of Recurrent Ovarian Cancer: Further Analysis of a Prospective Study, utilizes four independent statistical and analytical methods to demonstrate that ChemoFx is able to identify specific therapies, among the multiple available options, that differentially impact both progression-free (PFS) and overall survival (OS) in recurrent ovarian cancer patients.
In the study, 262 women with persistent or recurrent epithelial ovarian cancer were empirically treated with one of 15 standard recurrent therapies. Each patient’s tumor was also assayed for cytotoxicity against the same menu of therapeutic options. Patient ChemoFx results and their corresponding clinical outcomes were evaluated using multiple independent methods.
First, the ability of ChemoFx to predict patient outcome for the clinically administered therapy (match) was compared with marker results for randomly selected treatments for the same patient (mismatch), and demonstrated that the association of outcome and ChemoFx result for the administered therapy was stronger than for mismatched therapies (hazard ratio: 0.67 vs. 0.81, respectively). This indicated that a patient receiving a therapy that was designated as ‘sensitive’ by ChemoFx was more likely to experience a better outcome than a patient treated without marker direction.
Second, the influence of cross-drug response was examined by comparing the number of sensitive therapies for each patient’s tumor to the corresponding PFS, thereby demonstrating that the association between ChemoFx results and PFS is attributed to the ability of the marker to specifically identify sensitive therapies. Finally, clustering analysis, based on ChemoFx results, was neither associated with common clinical factors nor with patient outcome, again indicating the independent predictive ability of the marker. Collectively, these analyses support ChemoFx as a predictive marker and further confirm that patients who receive a ChemoFx ‘sensitive’ treatment experience improved outcomes, regardless of their overall drug sensitivity as measured by the marker.
These findings are particularly noteworthy, as nearly half of patient tumors displayed heterogeneity in ChemoFx results, demonstrating a large opportunity for the marker to positively impact patient outcomes. In the study, the median PFS of patients who received a ChemoFx ‘sensitive’ drug increased by 50% when compared to those who received ‘resistant’ treatments. This increase in PFS remained consistent regardless of the number of sensitive therapies across patients.
“It has been extremely challenging to design a clinical trial to determine the prediction capability of any assay examining sensitivity to chemotherapy, due to the heterogeneity of tumor response to available therapies and limited patient resources,” states Robert L. Coleman, MD, FACOG, FACS, Deputy Chair of the Department of Gynecologic Oncology and Reproductive Medicine at the University of Texas MD Anderson Cancer Center. “This study provided a unique opportunity to address marker prediction and prognostication by assessing outcomes of matched and mismatched therapy in the context of heterogeneous tumor response. This kind of data can create a shift in our approach to patient care within the ovarian cancer treatment community.”
ChemoFx is a proprietary drug response marker which quantifies an individual gynecologic cancer patient’s probable tumor response to specific treatments selected from the range of standard chemotherapeutic options. ChemoFx has been validated in previously conducted clinical studies, with data demonstrating a 14-month improvement in overall survival and 50% increase in progression-free survival when recurrent ovarian cancer patients are treated with sensitive therapies as indicated by ChemoFx.
About Ovarian Cancer:
More than 22,000 women in the United States are newly-diagnosed with ovarian cancer each year. Approximately 80% of all women with ovarian cancer have their disease recur, and 20-30% of recurrences occur within 6 months of the end of first-line therapy. The majority of patients with ovarian cancer (more than 70%), present with advanced disease at initial diagnosis, and women with advanced ovarian cancer tend to have multiple relapses and undergo several rounds of chemotherapy. There have been modest gains in ovarian cancer statistics in the last two decades, with only a small percentage of improvement in overall survival rates for recurrent ovarian cancer.
About Precision Therapeutics:
Precision Therapeutics, Inc., a life-science company located in Pittsburgh, PA, is dedicated to personalizing cancer care and improving patient outcomes. As leaders in the science of individualizing cancer therapy, Precision develops novel markers to help guide treatment decisions based on the biological processes of each individual’s cancer. In addition to ChemoFx, Precision also offers BioSpeciFx®, a portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis. For more information, visit: www.precisiontherapeutics.com