Patients with small kidney cancer tumors may be more likely to die from the cancer if they are treated with ablation rather than nephron-sparing surgery (NSS), according to researchers.

In a retrospective study of 8,818 patients with clinical stage T1a renal cell carcinoma (RCC), investigators found that those treated with ablation had a twofold increased risk of RCC-related death compared with patients treated with NSS, after adjusting for multiple potential confounders. Despite the increased relative risk of a kidney cancer death associated with ablation, the researchers noted that at five years, the absolute difference in risk is small, Jared M. Whitson, MD, and colleagues at the University of California San Francisco reported in BJU International (2012; published online ahead of print).

A total of 716 subjects (8.1%) died during follow-up; of these, 110 (15%) died from RCC: 91 (1.2%) in the NSS group and 19 (1.7%) in the ablation group. The disease-specific survival rate at five years was 98.2% in the NSS group and 94.4% in the ablation group.

For the study, the researchers used data from the Surveillance, Epidemiology and End Results (SEER) cancer registry. The study included patients with RCC tumors smaller than 4 cm and who had no evidence of distant metastases. Of the 8,818 subjects, 7,704 were treated with NSS and 1,114 underwent ablation.

Dr. Whitson's group noted that their study is the first well-powered investigation to compare the effectiveness of NSS and ablation. The study, however, had limitations, including a relatively short follow-up in the ablation group (median 1.6 years vs. 2.8 years in the NSS group). The authors pointed out, though, that in more than 100 patients in the ablation group who had more than five years of follow-up, the kidney cancer death risk appeared to increase relative to NSS.

Among the 1,114 patients who underwent ablation, 662 (59%) had cryoablation, 239 (21%) had ablation “not otherwise specified,” and 213 (19%) had radiofrequency ablation.

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FRANKFURT (Reuters) - U.S. health regulators are looking at whether Fresenius Medical Care violated any rules by failing to alert dialysis clinics about risks linked to one of its products.

Last November, the German company sent a memo to dialysis centers that it operates in the United States, warning them about a link between dosing errors with its GranuFlo product and a higher risk of cardiac arrest.

But FMC did not send the memo to other U.S. dialysis centers that may use GranuFlo, but are not operated by the company.

After learning of the memo in March, the U.S. Food and Drug Administration asked Fresenius to broaden its notification to all customers.

"As in other cases in which FDA learns of product-related hazards, we are evaluating whether Fresenius met its regulatory responsibilities," FDA spokeswoman Morgan Liscinsky said on Friday.

"Should we determine that Fresenius did not do so, Fresenius is subject to compliance action," Liscinsky said.

A spokesman for FMC, based at the group's German headquarters, said the November memo was based on preliminary findings and was meant to prompt further fact-finding within the company.

The FDA's March request was informal and subsequent talks led to FMC informing all clinics, he said. "There is no formal investigation by the FDA and we have no indication that there will be one."

FMC operates about a third of all U.S. dialysis centers for patients with kidney failure, but it also supplies dialysis machines and supplies to rival clinic operators there and in Europe.

The company, which makes almost two thirds of its revenue in North America, is controlled by German healthcare conglomerate Fresenius SE & Co KGaA.

In a November 4 memo to FMC's U.S. doctors, the company said statistics point to doctors giving too much GranuFlo to some patients, triggering cardiac arrest, according to the New York Times, which reported on the issue on Thursday.

"In light of these troubling findings," doctors should dose more carefully, the memo says, and "this issue needs to be addressed urgently."

(Reporting by Ludwig Burger; Additional reporting by Anna Yukhananov in Washington, D.C.; Editing by Erica Billingham and Tim Dobbyn)

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Special Photo Stewart Reese Jr. poses for a photograph with his daughter Bernita Reese, just days before she donated her kidney to him.

For 43 years, Bishop Stewart Reese Jr. led Bethesda Cathedral in Decatur. His sermons typically ran about 40 minutes. But when his kidneys started to fail, so did his preaching. Seven minutes was about as long as he could last, he said.

"I didn't have any energy at all," the 74-year-old Newton County resident said.

Today, Reese has a renewed lease on life, thanks to the actions of his daughter, Bernita Reese. The 46-year-old Ellenwood resident donated one of her kidneys to her father in May.

"I just feel like a new man," said Reese, who is home recovering from the operation.

Reese's kidney trouble began shortly after he had a stroke in 2009. Reese sought help from several doctors but they all recommended dialysis, a treatment he refused.

Dialysis seemed risky, said Reese, because he'd seen too many friends undergo dialysis and die.

One doctor administered a drug to Reese in an attempt to revive kidney function but to no avail. By the time Reese met with the doctor again, one kidney had completely shut down and the other functioned at 14 percent.

Bernita Reese accompanied her father and mother, Navoria Reese, to the meeting with the doctor and when she learned the severity of her father's kidney condition, she suggested an idea which took her father by surprise -- she offered her own kidney.

"I was floored, really," Stewart Reese Jr. said.

Bernita Reese said she hadn't really considered the option until the day she sat in the doctor's office with her parents.

"I really didn't know that his kidney was at the failing point that it was. I think the main thing is his refusing dialysis and him saying, 'If I have to go through dialysis, I would rather just give up on life.' That was hard to hear, much less imagine him wanting to give up on life because of a machine," said Bernita Reese.

"I said, 'If that's the case, why don't you take my kidney?'"

Bernita Reese said she didn't hesitate to aid her father, who had sacrificed so much to raise her.

"For me, it's just a gift you give back. You don't even have a choice," said Bernita Reese, who is employed at the DeKalb County Department of Recreation, Parks and Cultural Affairs.

Father and daughter underwent surgery on May 15 at Emory University Hospital. Doctors released Bernita Reese on May 17 and her father on May 19.

Navoria Reese cared for both her husband of 56 years and her youngest daughter at her home in Newton County the first few weeks after surgery.

"Bernita wanted to see her father live a normal life, and be spared the agony of being hooked up to a machine for countless hours a week," Navoria Reese said. "Her selfless act was simply beyond words and is absolutely amazing."

Reese said he's given his daughter a big hug and thanked her.

"I can't repay her for what she's done but I feel there's nothing too good for her," Mr. Reese said.

On Father's Day, Mr. and Mrs. Reese and their daughter will attend church at Bethany Cathedral, where the Reese's son is now head pastor. Then, the Reese family, which includes two daughters, one son and six grandchildren, will gather at the parents' home in Newton County for a dinner.

"It's just going to be delight seeing everybody," Mr. Reese said.

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But FMC did not send the memo to other U.S. dialysis centers that may use GranuFlo, but are not operated by the company.

After learning of the memo in March, the U.S. Food and Drug Administration asked Fresenius to broaden its notification to all customers.

"As in other cases in which FDA learns of product-related hazards, we are evaluating whether Fresenius met its regulatory responsibilities," FDA spokeswoman Morgan Liscinsky said on Friday.

"Should we determine that Fresenius did not do so, Fresenius is subject to compliance action," Liscinsky said.

A spokesman for FMC, based at the group's German headquarters, said the November memo was based on preliminary findings and was meant to prompt further fact-finding within the company.

The FDA's March request was informal and subsequent talks led to FMC informing all clinics, he said. "There is no formal investigation by the FDA and we have no indication that there will be one."

FMC operates about a third of all U.S. dialysis centers for patients with kidney failure, but it also supplies dialysis machines and supplies to rival clinic operators there and in Europe.

The company, which makes almost two thirds of its revenue in North America, is controlled by German healthcare conglomerate Fresenius SE & Co KGaA.

In a November 4 memo to FMC's U.S. doctors, the company said statistics point to doctors giving too much GranuFlo to some patients, triggering cardiac arrest, according to the New York Times, which reported on the issue on Thursday.

"In light of these troubling findings," doctors should dose more carefully, the memo says, and "this issue needs to be addressed urgently."

(Reporting by Ludwig Burger; Additional reporting by Anna Yukhananov in Washington, D.C.; Editing by Erica Billingham and Tim Dobbyn)

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