A new medication helps men suffering from one of the deadliest forms of cancer live longer, a Huntsman Cancer Institute doctor said.
Advanced prostate cancer is the second highest cause of cancer deaths in American men, second only to lung cancer. Less than 30 percent of men will survive after five years when prostate cancer spreads to other parts of the body, according to Dr. Neeraj Agarwal, a professor of medicine, physician and investigator at the Huntsman Cancer Institute.
But a new drug called apalutamide could change that.
The TITAN trial, which began in 2015, studied the safety and effectiveness of the medication. It targets the protein that drives cancer cells in men who have advanced prostate cancer, Agarwal said.
"So you're basically attacking a protein which is allowing the prostate cancer cell to multiply and metastasize and progress to different parts of the body," Agarwal explained. He participated in the study since its planning phase.
In those treated with apalutamide, researchers saw a 33 percent reduction in risk of death and a 52 percent reduction in risk of disease production. Side effects caused by the drug were well tolerated, Agarwal said.
The drug also delays the disease's progression and the need for chemotherapy.
During the clinical trial — which included more than 1,000 participants with newly diagnosed prostate cancer — some were treated with apalutamide and standard cancer treatment, while others received only standard treatment.
After the "stringent" trial, researchers this year learned that the men treated with apalutamide "were living much longer" as compared to those receiving only standard treatment, Agarwal said.
Patients receiving a placebo have now been allowed to cross over to the real drug, according to the doctor.
Noting developments doctors have made in cancer research, Agarwal said the findings weren't that surprising.
"The beauty of doing clinical trials, the most attractive part of doing clinical trials in today's time is that we're not really thinking of unknown chemicals … and hoping for a good result. Nowadays, clinical trials are using those medications which are very cleverly designed inside these laboratories after unraveling the key molecular drivers of cancer progression."
After recognizing the drivers, doctors can create a drug to target them.
"As opposed to 10 to 15 years ago, when clinical trials were using relatively not-so-smart molecules, the results of the clinical trials used to be less certain. Now you know you are hitting the right target," he said.
The drug was approved a few months ago for a "very small patient population" of those in later stages of prostate cancer, Agarwal said. But the TITAN trial's results could make the drug available to hundreds of thousands more men worldwide.
Apalutamide is awaiting approval from the United States Food and Drug Administration for use among those with newly diagnosed advanced prostate cancer. Agarwal expects that to happen before the end of the year.
The findings of the trial were also significant because doctors won't need state-of-the-art infrastructure to prescribe the drug. Doctors who work in small towns, away from large cancer centers, will be able to prescribe it.
"The beauty of this oral pill is it's easy to prescribe, it's easy to take, and the side effects are not more than what you see with the standard therapy right now," Agarwal said. "I call these advances paradigm-shifting advances."
"It's a real advance because this allows my patients and patients all over the world to take a bottle of oral pills from their doctors, go home, and take the medications by themselves," he added.
Agarwal said it's a "matter of pride" for him that Huntsman Cancer Center played a large part in studying a drug that "is so well-tolerated, improving lives and quality of life."
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This was a nice sized study. Apalutamide, despite its side effects, looks like it will have the potential to improve both quality and length of life for a very nasty form of cancer.
More about Apalutamide here: Side effects
ZitatApalutamide has been found to be well-tolerated in clinical trials,[15][12] with the most common side effects reported when added to surgical or medical castration including fatigue, nausea, abdominal pain, and diarrhea.[9][10][16] Other side effects have included rash, falls and bone fractures, and hypothyroidism, as well as seizures (in 0.2%), among others.[1][3][8] Apalutamide is an expected teratogen and has a theoretical risk of birth defects in male infants if taken by women during pregnancy.[1] It may impair male fertility.[1] When used as a monotherapy (i.e., without surgical or medical castration) in men, NSAAs are known to produce additional, estrogenic side effects like breast tenderness, gynecomastia, and feminization in general by increasing estradiol levels.[17] Similarly to the related second-generation NSAA enzalutamide but unlike first-generation NSAAs like flutamide and bicalutamide, elevated liver enzymes and hepatotoxicity have not been reported with apalutamide.[1]
Overdose
There is no known antidote for overdose of apalutamide.[1] General supportive measures should be undertaken until clinical toxicity, if any, diminishes or resolves.[1]
Interactions
Apalutamide has a high potential for drug interactions.[1] In terms of effects of apalutamide on other drugs, the exposure of substrates of CYP3A4, CYP2C19, CYP2C9, UDP-glucuronosyltransferase, P-glycoprotein, ABCG2, or OATP1B1 may be reduced to varying extents.[1] In terms of effects of other drugs on apalutamide, strong CYP2C8 or CYP3A4 inhibitors may increase levels of apalutamide or its major active metabolite N-desmethylapalutamide, while mild to moderate CYP2C8 or CYP3A4 inhibitors are not expected to affect their exposure.[1]