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Can new drug extend lives of Southwest Florida men with prostate cancer?


Naples Daily News (FL)

04-24-14

April 24--NAPLES -- Walter Corbin strikes up an easy conversation with the medical technicians who prepare him for an intravenous injection of Xofigo, a recently approved drug for advanced prostate cancer.

His engagement with staff members at 21st Century Oncology in Fort Myers seems fitting for someone who says he has enjoyed an adventure or two. He's got a sailor's weathered skin as proof.

Nothing in the 83-year-old's demeanor, or still-strong physique, indicates prostate cancer which has spread to his bones may get the better of him sooner rather than later.

His commute to the oncology center includes a boat ride from his winter home on exclusive Useppa Island, north of Pine Island Sound in Lee County. He divides his time between that relaxed island lifestyle to the one offered at Orcas Island in Washington state with his wife, Gayle.

He has on his side a good perspective, a doctor's counseling, and the potential the drug will extend his life.

Last Thursday, Corbin was getting his fifth injection of Xofigo, given monthly for six months. Side effects have been minimal for him and he feels good.

"You can't expect miracles but if this works out, great," said Corbin, who retired in 1990 from the electronics business in California. "The counseling is very, very important. They say you may die with it or from it. It's not material to me. It's the better quality of life."

Xofigo has been on the market since last year. It gained FDA approval in May 2013, three months ahead of schedule because of promising clinical findings that it helps stop the spread of cancer lesions in bone.

Manufactured by Bayer Pharmaceuticals, Xofigo is specified for patients with advanced forms of prostate cancer where earlier treatment courses of hormone therapy, radiation and surgery have failed.

"It is treating the spread of the cancer within the bone," said Dr. Keith Miller, a radiation oncologist with 21st Century Oncology and one of Corbin's doctors. "The goal is (helping) them keep the highest quality of life, and reducing pain and reducing complications like fractured bones."

Since the drug's approval, Miller and his colleagues at 21st Century have put 25 patients on Xofigo. The practice also had 12 patients enrolled in the drug's clinical trial.

The overall clinical results indicate a 30-percent reduction in the mortality rate of patients in the trial, Miller said. From another perspective, the drug will add three or four months to life expectancy.

"In the short term, there's less pain and they feel better," Miller said. Patients typically can reduce their dosage of pain medications. "But the big picture, we are not as far into it yet."

The toll of prostate cancer

The National Cancer Institute estimates 233,000 men will be diagnosed with prostate cancer this year and 29,480 men will die from it.

Prostate cancer is the second most common cancer in men in the United States, behind skin cancer, and affects one in six men. The average age of diagnosis is 67.

Before Xofigo, treatment options were limited for men whose cancer has metastasized into bone, where it can cause intense pain, weakness and fractures. What was prescribed is Quadramet, which can be administered every three months, Dawn Starr, clinical manager for 21st Century in Lee county, said.

The difference is Xofigo will treat the lesions in the bone while Quadramet only alleviates pain, she said.

The infusion with Xofigo takes minutes, and some patients may experience gastrointestinal upset afterward, Miller said. It is necessary to monitor a patient's blood count during the six-month treatment course, he said.

The blood tests are done before the initial injection and before each subsequent one, he said.

Starr said patients are different in how much pain relief they experience.

"Some come back after the first time and say they are feeling better," Starr said. "I didn't have anyone say they didn't feel better."

"We had a waiting list," she added referring to patients who were waiting for Xofigo to gain FDA approval. "People knew about it."

The treatment is expensive at $11,000 for each injection, which is covered by Medicare and other insurers, Starr said.

For patients with high deductibles or co-payments, Bayer offers an assistance program, she said.

The oncology practice is moving toward putting everyone on it who meets criteria of the cancer having spread to the bone and no other medical conditions that reduces life expectancy, Miller said.

Taking the cancer for real

Corbin was initially diagnosed with prostate cancer in 2002. He went through radiation treatment in Washington state and returned to his normal life.

"I pooh-poohed it," he said, adding that he was familiar with the controversy of the prostate-specific antigen, PSA, test and how it can give false positive results. "I turned my head."

Last year everything changed when blood tests showed his PSA was significantly high. He was put on hormone treatment with an injection every three months. He was experiencing a lot of pain and was put on prednisone, an anti-inflammatory medication.

He had his final hormone injection late last fall after returning to Florida. An acquaintance suggested he go see Dr. Constantine Mantz, an oncologist and chief medical officer at 21st Century.

"If ever a doctor gave encouragement and counseling, he was the finest," Corbin said.

That was an entirely different experience from the physician in the Seattle area he saw.

"In Seattle, it was like, 'This is it, good-bye,'" Corbin said, adding that the Seattle doctor knew about Xofigo. "He didn't refer me to an oncologist."

Mantz, at 21st Century, was clear about using Xofigo to go after the cancer. Corbin said no longer has pain, but he's not sure if that's a credit to the prednisone or the new medication.

A bone scan at the onset of treatment with Xofigo and a more recent scan shows a difference with the lesions appearing to be going away.

"The cancer is down, it looks like almost 50 percent," Corbin said. "You can see a diminishing of the cancer. For people like me, what is the alternative?"

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(c)2014 the Naples Daily News (Naples, Fla.)

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