ATLANTA—The rate of perioperative blood transfusion after nephrectomy appears to be higher in general practice than the rates commonly cited in published urologic reports, researchers reported at the American Urological Association 2012 Annual Scientific Meeting.

The results are drawn from a large population-based, retrospective study of patients who underwent nephrectomy for a renal mass. Overall, 18.2% of patients required a transfusion perioperatively, which is about three times the rate reported thus far in the literature.

Gino Vricella, MD, chief resident in urology at Case Western Reserve University in Cleveland, and colleagues determined the rates of blood transfusion as well as patient, surgeon, and hospital risk factors for transfusion in 10,902 patients who underwent a laparoscopic or open partial or radical nephrectomy for a renal mass over a recent five-year period. The procedures were performed at facilities in seven Canadian provinces, and information on patient demographics and treatment approach were obtained from a nationwide database.

“There are reports in the contemporary medical literature stating that patients who receive transfusions for whatever reasons have worse outcomes,” Dr. Vricella said. “However, most outcomes data in urologic oncology are reported by higher volume surgeons and institutions, and the paucity of population-based analyses means that our current understanding of expected outcomes after surgery for kidney cancer is susceptible to publication and reporting bias. This is especially true for highly technical procedures such as laparoscopic partial nephrectomy.”

He said that the study was undertaken to determine the transfusion rate for all “comers” and to identify specific factors that predict which patients will  require a transfusion.

Overall, 28.2% of patients undergoing open radical nephrectomy required at least one transfusion postoperatively.

The transfusion rate decreased steadily, with 12.7%, 9.2% and 8.6% of patients requiring transfusion after open partial nephrectomy, laparoscopic radical nephrectomy, and laparoscopic partial nephrectomy, respectively.

The transfusion rate was strongly associated with patient factors such as age and comorbidity such that transfusion rates were 11.2% and 14.5%, respectively, in patients under 50 years of age and patients with a Charlson co-morbidity score of 0 compared with 28.2% and 40.7% in patients 80 years of age or older and patients with a Charlson score of 3 or higher.

Other factors shown on multivariable analysis to be strongly associated with the need for transfusion were provider variables such as procedure type, surgeon and hospital volume. Year of surgery, gender, and income quintile had no impact on the transfusion rate.

“Our findings allow us to better counsel patients preoperatively, which, in turn, makes them more knowledgeable when providing informed consent,” Dr. Vricella said. “Before our study, we might have told patients that it was highly unlikely that they would need a blood transfusion given the 5% transfusion rate published in the literature. With our population-based data, we would now tell patients that their risk of requiring a transfusion is around 20%, so that if a patient does not want a transfusion for whatever reason—religious or otherwise—he or she is better informed about that risk before providing informed consent.”

He cautioned that a possible study limitation is the lack of pathology data. “For example, we don't know if the patient's renal mass was large or small because the information was not included in the data set we looked at,” he said.

Additionally, the investigators did not have information on patients' preoperative hemoglobin values. “So, a certain percentage of these patients may have had low values to begin with which would have necessitated transfusion, regardless of the nature of their procedure,” he explained.

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Aveo Oncology (Nasdaq: AVEO) of Cambridge and Astellas Pharma Inc. (TSE: 4503) of Tokyo  said they plan to start a new clinical trial in advanced renal cell carcinoma to establish more data for their investigational drug tivozanib when used as a first-line therapy in those cancer patients.

The study is designed to build upon safety profile demonstrated in TIVO-1 study, according to a statement from the companies. In February 2011, Aveo and Astellas entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib to treat a broad range of cancers.

The new trial, called TAURUS, will enroll about 160 patients at sites throughout the United States and Western Europe, the companies noted.

“With more treatment options available for patients living with cancer, it’s becoming increasingly critical to understand how patient preference is influenced by side effects and other related issues,” William Slichenmyer, M.D., and chief medical officer at Aveo, said in a written statement. “Following the positive findings from the Phase 3 TIVO-1 trial, the TAURUS study will allow us to further define the tolerability profile of tivozanib and understand the role that tivozanib could play in the treatment of first line advanced kidney cancer compared to a standard of care drug.”

According to Bernard Escudier, M.D., of Institute Gustave Roussy, who is principal investigator for the TAURUS study, patients and healthcare providers are looking for anti-cancer agents that are more effective and better tolerated than existing therapies. “The TAURUS study will help us better understand how the side effect profiles of drugs affect patients’ treatment choices,” he said in the companies’ press release. “The typical patient being treated for metastatic kidney cancer is middle-aged, active and is still in the work force and therefore the impact of side effects may be more important to them.”

TAURUS is a randomized, double-blind, crossover controlled, multi-center Phase 2 study comparing tivozanib versus sunitinib in patients with advanced renal cell carcinoma who have received no prior systemic therapy. The primary objective of the study is to compare patient preference after receiving both tivozanib and sunitinib in sequence.

According to the companies, renal cell carcinoma is the ninth most commonly diagnosed cancer in men and women in the United States. The disease accounts more than 90 percent of all kidney cancers.

Aveo’s stock is up 2.21 percent in afternoon trading at $11.97.

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rockwell medical tech inc (RMTI) Details

Rockwell Medical Technologies, Inc., an integrated biopharmaceutical company, engages in the manufacture, sale, and distribution of hemodialysis concentrates and other ancillary medical products for the treatment of patients with end stage renal disease in the United States and internationally. Its products include Renal Pure and CitraPure liquid acid concentrate, Dri-Sate dry acid concentrate and mixing systems, RenalPure powder bicarbonate concentrate, and SteriLyte liquid bicarbonate concentrates; and various ancillary products comprising blood tubing, fistula needles, specialized custom kits, dressings, cleaning agents, filtration salts, and other supplies used by hemodialysis providers. The company develops generic version of calcitriol, a vitamin D analogue for the treatment of secondary hyperparathyroidism. Its lead drug candidate is soluble ferric pyrophosphate, an element used in the formation of new red blood cells for the treatment of iron deficiency in anemia dialysis patients. Rockwell Medical Technologies, Inc. sells its products to hemodialysis providers through direct sales people and independent sales representation companies, as well as through independent sales agents and distributors. The company was founded in 1995 and is based in Wixom, Michigan.

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Researchers in Alberta, Canada, have found that untreated renal failure is significantly more common in older than younger individuals, according to a new report published in the Journal of the American Medical Association (2012;307:2507-2015).

In a study that included more than 1.8 million adults, the adjusted rates of untreated kidney failure cases among individuals in the lowest stratum of estimated glomerular filtration rate (eGFR 15-29 mL/min/1.73 m²) were 3.53 per 1,000 person-years for those aged 18-44 years versus 19.95, 13.25, and 8.54 per 1,000 person-years for those aged 85 years and older, 74-84 years, and 65-74 years, respectively.

Untreated kidney failure among patients aged 75 years or older with a baseline eGFR of 15-29 was about 2- to 10-fold more common than kidney failure treated by dialysis, according to the report.

The investigators defined untreated kidney failure as progression to an eGFR below 15 without renal replacement therapy.

The researchers, led by Brenda R. Hemmelgarn, MD, PhD, of Foothills Medical Centre in Calgary, observed that their results “suggest that the incidence of advanced kidney disease in the elderly may be substantially underestimated by rates of treated kidney failure alone and that untreated kidney failure may be more common than initiation of renal replacement at older ages.”

Dr. Hemmelgarn noted that the study findings also highlight that “CKD does progress among older adults, and suggests a need to prioritize the assessment and recognition of CKD progression among older adults so that shared decision making regarding strategies for management, including supportive care, can be made.”

In an accompanying editorial (pp. 2545-2546), Manjula Kurella Tamura, MD, MPH, and Wolfgang C. Winkelmayer, MD, MPH, ScD, both of the Stanford University School of Medicine in Palo Alto, Calif., noted that the magnitude of untreated kidney failure among older adults does not necessarily imply inappropriate withholding of treatment. “While the study describes the rates of untreated kidney failure for older adults,” they wrote, “it does not provide information on the reasons these patients did not undergo dialysis or kidney transplantation or about alternative treatments they might have received. It is possible that older patients may have decided, after a shared decision-making process with their medical team and family, to forego dialysis and to opt for supportive care.”

Drs. Tamura and Winkelmayer concluded that the work by Dr. Hemmelgarn and colleagues “highlights a potentially sizeable unmeasured burden of untreated kidney failure among older adults. It is of paramount importance to refine the current understanding of what constitutes appropriate treatment for kidney failure, which factors influence the decision-making process, and which methods are optimal for aligning treatment plans with patient goals and prognosis.”

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