CHICAGO—Intermittent androgen deprivation therapy (ADT) has some quality-of-life (QOL) benefits for men with metastatic prostate cancer (PCa), but overall survival times are inferior to those seen with continuous ADT, according to the findings of a 17-year study (SWOG9346) presented at the American Society for Clinical Oncology 2012 annual meeting.

“Some doctors recommend intermittent hormonal therapy to men with metastatic prostate cancer, believing it will reduce their risk of side effects without compromising their outcome, but these findings demonstrate a downside to this approach for certain men,” said lead researcher Maha Hussain, MD, Professor of Medicine and Urology at the University of Michigan Comprehensive Cancer Center in Ann Arbor. “The findings clearly demonstrate that intermittent hormonal therapy is not as effective for all patients with metastatic prostate cancer. These findings are likely practice changing for many doctors in the U.S. and abroad who routinely use intermittent therapy; specifically, physicians must counsel interested patients regarding the potential negative impact on survival with intermittent therapy.”

The study enrolled 3,040 men with hormone-sensitive, metastatic prostate cancer between 1995 and 2008.  All men received an initial course of androgen-deprivation treatment for seven months. The 1,535 eligible men whose PSA level dropped to 4 ng/mL or less by the end of those seven months were then assigned at random to stop therapy (the intermittent therapy group) or continue therapy (the continuous therapy group).

Those randomized to the intermittent therapy arm had their treatment suspended until their PSA rose to a predetermined level, at which time they started another seven-month course of ADT. The patients cycled on and off therapy in this way as long as their PSA levels continued to respond appropriately during the “on” cycle.

The 1,535 eligible patients had a median age of 70 years; 48% had extensive disease and 12% had received prior neoadjuvant ADT. A total of 765 were randomized to continuous therapy and 770 patients were randomized to the intermittent arm. Men on continuous therapy had a median overall survival time of 5.8 years from the time of randomization, with 29% of these men surviving at least 10 years. Those on intermittent therapy had a median overall survival time of 5.1 years, with 23% surviving at least 10 years from randomization. Men with minimal disease (disease that had not spread beyond the lymph nodes or the bones of the spine or pelvis) did significantly better on continuous therapy, whereas men with extensive disease seemed to do about as well using either treatment approach.

“In the past when it came to using hormone therapy in this disease, doctors viewed the disease as one entity and adopted a ‘one size fits all' approach,” Dr. Hussain said. “Based on this study's findings, it seems that one size does not necessarily fit all.”

Intermittent hormonal therapy appeared to be safe in prior studies, but those studies generally included either men whose only evidence of prostate cancer progression was an increase in PSA level (as opposed to radiographic evidence of disease spread), or men with wide-ranging stages of disease (not just metastatic cancer).

Additional exploratory subgroup analyses of these new data indicated that after a median follow-up of 9.2 years, the median overall survival time for those with minimal disease was 7.1 years on continuous ADT compared with only 5.2 years on intermittent treatment. Patients with extensive disease had median overall survival times of 4.4 years on continuous therapy and 5.0 years on intermittent therapy. There was no evidence that the treatment effect differed by race. The study showed that Grade 3/4 related adverse events were similar for intermittent and continuous treatment (30.3% vs. 32.6%).

With respect to QOL measures, which were compared during the first 15 months following randomization, more men receiving intermittent rather than continuous therapy had significant improvements in the  level of sexual functioning..

“There is some improvement in aspects of quality of life, but the durability is the issue,” Dr. Hussain told Renal & Urology News. “Our study demonstrates that what may appear safe may not be completely so and it sometimes takes a large study to determine this. It's important to look beyond PSA responses when evaluating hormone therapy approaches and also it's important to have a control group in performing the trials.”

Even though these data showed potential QOL improvements with intermittent therapy, the primary findings of the study demonstrate that intermittent therapy is inferior with regard to overall survival, which should be the primary consideration when counseling all patients interested in intermittent therapy, particularly those with minimal disease, she said. 

“This clinical trial will change the use of intermittent therapy,” said study co-investigator E. David Crawford, MD, Professor of Surgery/Urology/Radiation Oncology at the University of Colorado in Denver. “This is the largest study to date and one we have all been waiting for. It shows that intermittent therapy is inferior to standard continuous androgen ablation. There were flaws in other trials such as not powered to show equivalence or even slight but significant differences.”

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The last time I wrote about Jason LaHatte was in August, 2010. He was 13 and about to start eighth grade at Jesuit High School, and he was excited about playing trumpet in the Blue Jay Marching Band. But one thing was slowing him down: He needed a new kidney, preferably from a living donor.

“I wish I didn’t have to get one, but I know I do,” he told me. “It’s just aggravating to have to do it now because they put me in the accelerated program at Jesuit, and I’m going to have a lot of makeup work.”

After the story appeared, many people who had type O blood contacted me and Jason’s parents, Jonnie and Joe LaHatte, wanting to offer Jason a healthy kidney. But now, nearly two years later, he’s still waiting.

“It’s a never-ending story,” Jonnie said, when we sat down to talk at the LaHattes’ home in Metairie a few days ago.

Jason’s story began when he was 5 and he became ill during a family trip to the beach. As soon as they got home, Jason’s pediatrician did some blood tests and sent the LaHattes to Children’s Hospital where they learned the heart-breaking news: Their little boy had end-stage kidney disease and needed a new kidney.

Two weeks later, Jason went home with a shunt in his stomach and a dialysis machine. And for 10 hours every night he was on dialysis.

The LaHattes learned that kidney disease is called “the silent killer” because people die waiting for a donor. They also learned that a kidney from a living donor has less chance of being rejected than a kidney from someone who has died. So they, their two older sons, and their extended family got tested, but nobody was a good match.

Jason didn’t do well on dialysis and was often too sick to attend kindergarten at St. Ann Elementary School in Metairie. But in September the LaHattes listened to a life-saving message on their answer machine. It was from Cindy Hudson, who had known Jonnie and Joe from years earlier, when their older sons were grade-school friends. She had heard about Jason from her sister, who worked at St. Ann’s.

Hudson said, “I have type O blood, and I’ll give you a kidney.”

She proved to be a perfect match, and the transplant was done in November 2002, two days after Jason’s sixth birthday.

“Cindy is still doing fine,” Jonnie said. “She said if she had another kidney to spare, she’d give it to Jason.”

Hudson’s kidney gave Jason nearly eight trouble-free years. But two years ago, it began to fail, and the LaHattes began looking for a new one. Several people were tested in late 2010, and in December, they thought they had a donor. The transplant was scheduled over the holidays, but when Jason went into the hospital, the doctor noticed he was pale and dehydrated. Tests showed he had a serious virus, and he spent a week in the hospital recuperating.

“They canceled the transplant,” Jonnie said.

Later, the donor changed his mind, and they were back where they started. Still, Jason managed to keep going without dialysis, and last June the LaHattes took a special trip.

“We went to Lourdes, France,” Jonnie said.

Lourdes is the little town in southern France where Bernadette Soubirous had visions of the Virgin Mary in 1858. The 14-year-old discovered a spring near the grotto where she saw the Blessed Virgin, and it has been flowing ever since. Thousands of pilgrims visit Lourdes every year to bathe in the healing waters there.

“The bath was the best part,” Jason said. “They lay you down in the water and it’s really cold, but when you get out, you’re warm and dry.”

The LaHattes were able to go because of a nurse who volunteers on the special needs pilgrimages with the North American Lourdes Volunteers.

“She had a son who went to school with Jason’s older brother, and she had been praying for Jason,” Jonnie said. “She got someone to sponsor Jason, so how could we say no? It was like Mary was talking to us.”

At first, only Jonnie and Jason were supposed to go, but then the group offered to let Joe go along as a volunteer. He was even able to go in the water with Jason.

“It was touching, I tell you,” Joe said. “There’s so much faith there.”

It was a memorable week for all three of them, and they came home believing they would find a healthy kidney for Jason soon. But by January 2012, he was still waiting. By then, his kidney was functioning at less than 10 percent, and he was placed on the transplant list. And he was back on dialysis, something he had been dreading.

“I still remembered it from the last time,” he said.

Now, the teenage hangout room in the LaHattes’ house is a place to store boxes and boxes of supplies, and every night Jason is hooked up to a dialysis machine when he goes to bed.

“But I don’t feel bad. There’s not much I can’t do,” he said.

Jason is an honor-roll student at Jesuit and in the marching, jazz and concert bands. During Carnival season he marched in the Bacchus parade and the Carrollton parade and also was an honorary 610 Stomper in Thoth.

“That was fun,” he said.

Jason tries to make the best of his situation. Before heading to the Muses parade, he made a sign that said, “On dialysis. Need kidney or shoe.” It worked so well he made another sign Mardi Gras morning and substituted “coconut” for “shoe.”

“I got 18 coconuts and eight shoes,” he said.

The day before Easter the LaHattes got a call saying that a young organ donor with type O blood had died in an accident. By that afternoon, they were at Children’s Hospital thinking that their prayers were about to be answered. A few hours later, though, they learned another boy was being considered.

They spent the night still hopeful, but in the morning the doctor came in and told Jason the other boy was a better match.

“We thought there would be two kidneys, but one was damaged in the accident,” Jonnie said.

So they keep waiting, and they keep praying.

“We should have enough prayers to get a new kidney," Jonnie said. "We have people from every religion praying. We have people in every part of the country."

After Jason got his first transplant, the Louisiana Make-A-Wish Foundation sent the LaHattes to Disney World for a wonderful vacation.

“And after I get my surgery, I’ll get another wish from Make-A-Wish,” he said.

But Jason has no idea what he’ll wish for. All he really wants is a kidney that works.

If you are healthy, have type O blood, are between 18 and 45 and want to learn more about becoming a donor for Jason, contact Joe LaHatte at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or Jonnie LaHatte at This e-mail address is being protected from spambots. You need JavaScript enabled to view it . To sign up to be an organ donor, go to Donate Life Louisiana. 

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