Abstract
BackgroundThis study was performed to determine if a chemotherapy-induced apoptosis assay (MiCK) could predict the best therapy for patients with ovarian cancer.MethodsA prospective, multi-institutional and blinded trial of the assay was conducted in 104 evaluable ovarian cancer patients treated with chemotherapy. The MiCK assay was performed prior to therapy, but treating physicians were not told of the results and selected treatment only on clinical criteria. Outcomes (response, time to relapse, and survival) were compared to the drug-induced apoptosis observed in the assay.ResultsOverall survival in primary therapy, chemotherapy naïve patients with Stage III or IV disease was longer if patients received a chemotherapy which was best in the MiCK assay, compared to shorter survival in patients who received a chemotherapy that was not the best. (p < 0.01, hazard ratio HR 0.23). Multivariate model risk ratio showed use of the best chemotherapy in the MiCK assay was the strongest predictor of overall survival (p < 0.01) in stage III or IV patients. Standard therapy with carboplatin plus paclitaxel (C + P) was not the best chemotherapy in the MiCK assay in 44% of patients. If patients received C + P and it was the best chemotherapy in the MiCK assay, they had longer survival than those patients receiving C + P when it was not the best chemotherapy in the assay (p = 0.03). Relapse-free interval in primary therapy patients was longer if patients received the best chemotherapy from the MiCK assay (p = 0.03, HR 0.52). Response rates (CR + PR) were higher if physicians used an active chemotherapy based on the MiCK assay (p = 0.03).ConclusionThe MiCK assay can predict the chemotherapy associated with better outcomes in ovarian cancer patients. This study quantifies outcome benefits on which a prospective randomized trial can be developed.
Highlights
Epithelial ovarian cancer is responsive to several chemotherapeutic drugs
The microculturekinetic test (MiCK) assay for drug-induced apoptosis is a non-genomic test
In addition to testing in AML, it has been undergoing testing in solid tumors including breast cancer [6], endometrial cancer [7], lung cancer, miscellaneous solid tumors and hematologic malignancies. These results indicate that the MiCK assay is more predictive of response and survival than almost all currently available genomic tests
Summary
Epithelial ovarian cancer is responsive to several chemotherapeutic drugs. There is considerable variability in individual response to these drugs in combination or as single agents. Oncologists have wanted to develop an assay that can predict response to chemotherapy drugs and combinations to allow individualized cancer therapy. The issue of predictive testing for choosing chemotherapy for cancer patients is of very high interest. The MiCK assay for drug-induced apoptosis is a non-genomic test. Assays for chemotherapy resistance have been developed in the past, but their application in ovarian cancer has been of limited usefulness [1]. NCCN acknowledges that some institutions do use these tests in patients, but their general use is not guideline-approved [2]. This study was performed to determine if a chemotherapy-induced apoptosis assay (MiCK) could predict the best therapy for patients with ovarian cancer
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