CHICAGO, May 20 Precision Therapeutics Inc. announcedtoday that the ChemoFx(R) Assay, a cell-based test that examines the responseof a specific patient's tumor to various chemotherapies, correlates withsignificantly longer overall survival (OS) in patients with primary ovariancancer. Patients who received a treatment determined by ChemoFx to lead tothe best tumor response had an overall survival 1.4 times longer than thosereceiving a treatment shown by ChemoFx to be non-responsive.
Despite the fact that all patients had the same type of tumor, 88 percentof patients exhibited varying degrees of response to different agents whenevaluated by the cell-based test. The analysis also found that nearlytwo-thirds of patients' tumors were more responsive to a treatment identifiedby ChemoFx, than to the treatment they actually received. Based on theseresults, a mathematical model was created to estimate survival had patientsbeen treated with a drug that ChemoFx identified as more likely to result in agreater tumor response. The analysis found that median OS could be extendedas much as 23 to 38 months.
"These overall survival data demonstrate that the responsiveness totreatment established by this sensitivity assay in the laboratory setting, mayin fact translate into meaningful clinical outcomes for patients," said ThomasJ. Herzog, MD, director of gynecologic oncology at the Columbia UniversityMedical Center and lead investigator of the study. "If these results areconfirmed in current ongoing trials, this will be a significant step towardsestablishing individualized treatment strategies for patients who will requirechemotherapy."
About the Study
Patients analyzed in the study had stage II-IV primary epithelial ovariancancer that was tested by ChemoFx between 1997 and 2003, and received at leastone course of chemotherapy. The study evaluated differences in OS betweenpatients who received treatment that was deemed responsive,intermediate-responsive or non-responsive based on ChemoFx test results.
When accounting for cancer stage and debulking -- the reduction of tumorsize due to surgery or radiation treatment -- overall survival wassignificantly associated with the ChemoFx Assay and the cancer stage. In themodel simulating improved survival if patients were treated with a therapythat caused a greater tumor response, median OS of patients treated with anAssay non-responsive drug could be improved from 39.2 to 62.5 months andmedian OS of patients treated with an Assay intermediate-responsive drug couldbe improved from 62.5 to 101.3 months.
"People with cancer often require additional treatment after receiving thestandard of care chemotherapy. ChemoFx Assay can provide valuable informationthat could spare the patient from unnecessary toxicity associated with apotentially ineffective treatment," said Sean McDonald, CEO PrecisionTherapeutics. "The goal of ChemoFx is to empower patients and physicians withadditional diagnostic information to help determine the most appropriatecourse of therapy for each individual patient."
This retrospective, multi-center analysis is a published abstract at theAmerican Society of Clinical Oncology (ASCO) annual meeting in Chicago and isavailable at www.asco.org.
ChemoFx is a decision support tool that measures a specific patient'stumor response to various types, combinations and doses of chemotherapyselected by the patient's physician. The laboratory test examines how manycancer cells are killed after exposure to treatment, using a patient's livingcancer cells that have been removed during a biopsy, aspiration or surgicalprocedure. ChemoFx can be used in primary, recurrent, and metastatic tumors.
ChemoFx can be tested in all solid tumor types, with ovarian and breasttumors being primarily tested. Other solid tumors most commonly tested includeen