ANN HARBOR, MI (Ivanhoe Newswire) - A drug being investigated right now could prove to be a big breakthrough for men with late stage prostate cancer, especially in cases where the disease has spread to the bone.
Gino Polidori spent a lot of time restoring this classic Army Jeep. It's a reminder of a life spent serving in the military and as a lawmaker. But this family man's most important contribution may be what he's doing right now, testing a new drug for his disease: advanced prostate cancer.
"I feel it's genetic, and it's going follow in the family tree," Gino told Ivanhoe. "Here's an opportunity for them to find something to help somebody else down the road."
The experimental drug, Cabozantinib, works by targeting two proteins linked to the growth and spread of prostate cancer. In a trial of 171 men with metastatic prostate cancer, 74 percent had their tumors shrink. Sixty seven percent of patients with pain reported less pain. Scans show in 82 patients, bone metastases were partially or completely resolved. Doctor Maha Hussain co-authored the drug study; she said its anti-cancer effects are very promising.
"It does appear to slow the cancer from growing, but it does not cure the cancer, obviously," Maha Hussain, M.D., FACP, associate director of clinical research and co-leader of the prostate cancer program at the University of Michigan Comprehensive Cancer Center, explained. "The early signs that we have seen have been encouraging and dramatic."
For Gino it's an opportunity to slow his cancer and relieve his pain. He hopes someday no one will have to experience what he's living through.
Right now researchers are continuing to evaluate the drug not only for prostate cancer, but for patients with other cancers including ovarian and breast cancers that have spread to the bone.
BACKGROUND: Prostate cancer is cancer that occurs in a man's prostate. It is one of the most frequent forms of cancer affecting men. About one in every six men will be diagnosed with this disease sometime during the course of his life. (SOURCE: www.mayoclinic.com)
TREATMENT: There is no "one size fits all" treatment for prostate cancer. For prostate cancer in its early stages treatment may include:
Surgery (radical prostatectomy) Radiation therapy, including brachytherapy and proton therapy If the prostate cancer has spread, treatment may include: Hormone therapy (medicines to reduce testosterone levels) Chemotherapy (SOURCE: www.ncbi.nlm.nih.gov/pubmedhealth, www.pcf.org)
PREVENTION: Here are a few ways men can lower their risks of prostate cancer:
Eat fewer calories or exercise more so that you maintain a healthy weight. Try to keep the amount of fat you get from red meat and dairy products to a minimum. Watch your calcium intake. Do not take supplemental doses far above the recommended daily allowance. Some calcium is OK, but avoid taking more than 1,500 mg of calcium a day. Eat more fish – evidence from several studies suggest that fish can help protect against prostate cancer because they have "good fat" particularly omega-3 fatty acids. Avoid Trans fatty acids (found in margarine). Try to incorporate cooked tomatoes that are cooked with olive oil, which has also been shown to be beneficial, and cruciferous vegetables (like broccoli and cauliflower) into many of your weekly meals. Soy and green tea are also potential dietary components that may be helpful. (Source: www.pcf.org)
LATEST BREAKTHROUGHS: A new drug called cabozantinib is showing early promise treating patients with prostate cancer, particularly against tumors that have spread to the bone.
"The most striking finding is the fact that we saw broad evidence of anticancer effects including shrinkage of tumors in about 70 percent of patients, dramatic improvements in bone scans, pain improvement in patients who had pain to start with and overall delay in the progression of the cancer," Dr. Maha Hussain, an Associate Director for Clinical Research at University of Michigan, said.
In addition, among patients who were on narcotics due to bone pain, 67 percent reported less pain and 56 percent either stopped taking narcotics or reduced the dosage. Also, more than two-thirds of patients had some tumor regressions in areas of spread outside the bone. The treatment effects lasted on average 29 weeks. The study found moderate side effects from cabozantinib, including fatigue, gastrointestinal symptoms and high blood pressure. (SOURCE: www.cancer.med.umich.edu, Interview with Ivanhoe Broadcast News)
Dr. Maha Hussain, Professor of Medicine and Urology at the University of Michigan talks about a new pill to help prostate cancer patients and how it's affecting tumors and pain.
Has there been an advance in prostate cancer treatments over the last couple of years?
Dr. Hussain: This is an excellent question because if you had asked me this question 15 years ago, I would say, not really. However, in last 10 years there have been tremendous advances. Its important to point out however, that the vast majority of patients newly diagnosed with prostate cancer will not die of prostate and a large percentage of them will be cured of the disease. However, prostate cancer can be deadly and the patients who end up dying from it are those who develop metastatic disease; a cancer that spreads to bone, lymph nodes, or other areas.
What kind of advances have we seen?
Dr. Hussain: Prostate cancer is still the second major leading cause of cancer death in the United States in men. Over 28,000 men are forecasted to die from it in 2012. Up until 1996 there was one drug that was approved by the FDA for men who have metastatic prostate cancer that is no longer responsive to hormone treatment. Since then we now have nine drugs that have been FDA approved for this setting ; 4 drugs were approved because they prolong life (Taxotere, Cabazitaxel, Abiraterone and Provenge) Two recent agents (MDV3100 and Alpharadin) have also demonstrated a survival improvement in late stage prostate cancer and are likely to receive FDA approval. Other approved drugs have effects on pain or minimize the damage of the cancer on the bone. So in summary this has been a fantastic decade for prostate cancer. Having said that, there is a lot more work to be done.
Tell me a little bit about the trial.
Dr. Hussain: The trial tested a drug called Cabozantinib, otherwise known as XL-184. This is a drug that interferes with several aspects that are critical for prostate cancer growth and spread. It also affects the environment surrounding the prostate cancer cells particularly in the bone. It's not a chemotherapy nor is it a hormonal agent. The study was designed to look at whether the drug has anticancer effects in patients with a variety of cancers; one of the groups was prostate cancer. The rational for testing the agent was based on the scientific information regarding the biology of prostate cancer and observed effects of the drug based on preclinical testing. The study that we have reported earlier dealt with patients who either had hormonally resistant prostate cancer with no prior chemotherapy or patients whose cancers progressed on chemotherapy or other treatments.
What are you finding with the patients?
Dr. Hussain: The most striking finding is the fact that we saw broad evidence of anticancer effects including shrinkage of tumors in about 70% of patients, dramatic improvements in bone scans, pain improvement in patients who had pain to start with and overall delay in the progression of the cancer. The drug has moderate but manageable side effects. The totality of the early signs that we and other investigators have seen have been quite encouraging.
You had talked about the response in pain. What does that indicate? Does that indicate shrinkage?
Dr. Hussain: The growth of prostate cancer in the bone is governed by complex mechanisms that involve bone destruction, new bone formation and inflammatory changes. These changes result in pain. So in my assessment the pain improvement with this drug is likely multifactorial as a result of shrinking the tumor itself and impacting other processes. This is a great question because we do not know exactly know how this drug works in prostate cancer patients. Therefore to improve our understanding members of our prostate cancer program are conducting studies to better understand the process both in the lab (Dr. Evan Keller, who specializes in bone biology) and in patients with a study lead by my colleague Dr. David Smith
The drug is not yet available to patients correct?
Dr. Hussain: That is correct. It is an experimental drug so its only available as part of a clinical trial.
What is the next step then?
Dr. Hussain: I think the next step is to complete the studies that are being done at this moment to get a better feel for the overall effect and its duration. The sponsor has studies evaluating this agent in either end stage population of patients who may not have other standard options or in patients with pain. We and others are conducting institutional clinical trials that are aimed at better understanding the effect of the drug or evaluating it in combination.
Are there side effects?
Dr. Hussain: Yes. The most prominent side effects that we have seen have been fatigue , loss of appetite, diarrhea, constipation, soreness of the mouth and soreness of the hand and the feet, amongst other side effects. Most of the side effects improve by reducing the dose and most patients are able to continue therapy, but certainly the side effects are not to be taken lightly.
How encouraging is it to have another potential option out there?
Dr. Hussain: I think it is extremely exciting because there is continued need for effective agents in this disease and because as a "first" in class this drug opens the door for possibilities of better drug development capitalizing on knowledge derived from using/testing it.
Why should patients enroll in the trial?
Dr. Hussain: As a physician my role is to provide the best options of care to patients. Research is what will give us the cure for cancer. If it was not for the patients volunteering for this and other experimental agent we will not be where we are today in terms of this agent or other established agents. Patients volunteering and partnering with their physicians to get into clinical trials, whether it is this drug or other drugs, is very critical if we are to make progress in any cancer including prostate cancer.
FOR MORE INFORMATION, PLEASE CONTACT:
University of Michigan Cancer Answer Line 800-865-1125
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