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Are there patients other than BRACA positive who might be candidates for a PARP inhibitor?
Which mutations are eligible for Olaparib?
What are the toxicities associated with OLAPARIB?
How long do you treat patients with Olaparib?
Do you prescribe antiemetics?
Future trials
Are there unique toxicities with olaparib?
Contextual Synthetic Lethality
What do we know about microsatellite instability in ovarian cancer?
What is genomic scarring?
Background on clinical trials — Clinical trials are an important part of expanding treatment options for men with prostate cancer, and they are generally designed to address an unmet need. In this case, the unmet need is men with advanced prostate cancer who have failed to respond to either Xtandi or Zytiga (but not both) and to chemotherapy. Men in this situation have limited options moving forward.
Control (or status quo) arm of the study — The status quo for men in this situation has been to switch to whatever 2nd generation hormone therapy the patient has not yet taken; however, this is usually ineffective. This is the form of therapy that will be given in the control arm of this study
Experimental arm of the study — Merck pharmaceuticals is evaluating the efficacy of the combined use of two of its drugs, Lynparza and Keytruda, to compare against the control arm of the study. Both medicines are FDA--approved to treat other forms of cancer.
Background on the agents used in this study, Lynparza — Lynparza and Keytruda have both been shown to have activity in prostate cancer. Lynparza is especially useful in men with BRCA mutation, however, a BRCA mutation is not necessary to participate in the study. Lynparza has side effects similar to chemotherapy (fatigue, low blood counts) except without hair loss. It comes in the form of a pill and is taken twice a day. Patients on Lynparza need to be monitored as if they were undergoing chemotherapy.
Background on the agents used in this study, Keytruda — Keytruda is an immune medication that "takes the brakes" off the entire immune system. It is an infusion every three weeks. It is usually well-tolerated but around 20% of men will experience side effects due to overactivity of the immune system (asthma, diarrhea, rashes).
Lynparza and Keytruda are both potent agents and side effects will be an issue, but men who are in the situation to qualify for this trial do not have many other options.