Gemcitabine and Cisplatin With Enzalutamide Effectively Targets AR+ Metastatic Bladder Cancer

Release Date: 20-Sep-2019

The clinical data for the combination of enzalutamide (Xtandi) with gemcitabine and cisplatin shows that the effect is safe and tolerable in the case of metastatic bladder cancer. It enhances the Targeting action of androgen-receptor (AR) signaling in metastatic bladder cancer. This results is based on the phase I/Ib trial with is considered a safe and tolerable regimen, based on the results of a phase I/Ib trial.


During the dose-escalation phase of trial, patients with AR-positive and AR-negative disease are taken and followed the 3+3 design. The 2 cohorts were selected during the study and both of them were treated with enzalutamide, either 80 mg or 160 mg. A standard dosage of gemcitabine is also given to the patient. Then, in the dose-expansion phase, 12 patients with stage IV AR-positive BC were treated with the proper dose of enzalutamide discovered in the previous phase (160 mg).


These dosages were continued for up to 6 cycles. Enzalutamide was then given as maintenance therapy until disease progression. The results from the trial found enzalutamide plus gemcitabine and cisplatin to be safe.  The toxicities generated were also tolerable, which makes the study successful.


Furthermore, the median progression-free survival was 7.68 months and the median overall survival was 10.59 months. Of the 8 evaluable patients, 1 achieved a complete response and 4 had stable disease. This wills clearly indicates the synergistic effect of this combination and this combination will be used in upcoming years in the management of metastatic prostate cancer. 


According to Shilpa Gupta, MD, associate professor of medicine, University of Minnesota, we know that immunotherapy has changed the treatment paradigm for bladder cancer, but targeted therapies have a lot of scope we need to explore and AR is a pathway that is upregulated in bladder cancer and we did the first trial looking at AR inhibitor enzalutamide in combination with gemcitabine and cisplatin as first-line therapy in metastatic bladder cancer.

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