Biochemical Correlates for Clinical Response to Paclitaxel
Creators: name: University Of California Office Of The President
Publisher: name: University of California Office of the President
publisherIdentifier: https://ror.org/00dmfq477
publisherIdentifierScheme: ROR
Year: 2024

description: Since only chemotherapy (and hormonal therapy in specific subsets of patients) can reduce the risk for breast cancer to relapse and to affect survival, the recommendation for most breast cancer patients is to undergo adjuvant chemotherapy (after surgical removal of the tumor). Unfortunately, most patients derive no benefit from adjuvant chemotherapy. Only about one in ten women who are treated by conventional adjuvant chemotherapy benefit from it while the remaining nine derive no benefit, either because they would have fared as well in the absence of systemic treatment or because they will recur despite it.Patients and doctors share the frustration of lacking ways to pre-select that one patient in every ten who would benefit from adjuvant chemotherapy.
 
 
 
 
 
 
 
 The goal of this pilot study is to identify those patients who are most likely to benefit from treatment with paclitaxel. We think that it is very useful to monitor the effect of chemotherapy on the original tumor instead of waiting until the primary cancer has been removed and then giving chemotherapy. We will test the effect of a dose-intensive regimen of paclitaxel, a very active drug in breast cancer, on the primary tumor. We will monitor the tumor for 6 weeks of treatment then we remove the area of the breast that contained the original tumor (by lumpectomy or mastectomy, per patient’s choice). By measuring the extent of residual cancer, we predict that we will be able to find a large range of tumor response: in some women the cancer cells may have disappeared while in others the tumor may persist. By assuring that some of the original tumor tissue is collected through a small biopsy before paclitaxel treatment, we can study the original biological features of each tumor and attempt to correlate them with the response we found in the surgical specimen after paclitaxel therapy. This method may enable us to identify specific markers in the original tumor that can predict for the clinical response to paclitaxel.
 
 
 
 
 
 
 
 We plan to accrue a total of 45 women over 18-24 months to this study, by joining the efforts of three separate institutions, the University of Southern California, Mayo Clinic-Jacksonville and New York University. By collaborating we will be able to generate very important preliminary data in a relatively short time. Our pilot study is unique in having selected a paradigm of clinical research that by using the pre-operative dose-intensive, single agent paclitaxel we will be able to: a) measure chemosensitivity directly in the breast cancer and b) understand which molecular characteristics in the tumor may predict for response.
 
 
 
 
 
 
 
 The work proposed may generate the basis for designing more patient-specific chemotherapy treatment, to optimize the chances of success of the available chemotherapy agents. In the future, studies like this will enable us to match the optimal treatment to each breast tumor, based on the tumor characteristics. We expect a more patient-specific use of chemotherapy agents to impact favorably on the mortality from breast cancer.