BOSTON—Pediatric renal graft survival has improved over time, researchers reported at the 2012 American Transplant Congress.

Kyle J. Van Arendonk, MD, and colleagues at Johns Hopkins University School of Medicine in Baltimore analyzed graft survival among 16,266 patients younger than 18 years who received a kidney-only transplant from 1987 to 2010. One-, five, and 10-year graft survival was 80.9%, 58.3%, and 44.5% for transplants performed in 1987 compared with 93.4%, 73.6%, and 55.5% for transplants performed in 2000, the most recent transplants for which the investigators had 10 years of follow-up

With each successive year, the risk of graft loss decreased by 4%, after adjusting for possible confounders. The researchers observed similar trends for both living and deceased donors. Graft survival improvements were significantly greater in the first year after transplantation compared with beyond one year. In the first year post-transplant, the risk of graft loss decreased by 8% with each successive year, whereas beyond one year, the risk decreased by 2% with each successive year.

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CHICAGO—Axitinib may provide better outcomes than sorafenib as second-line treatment for patients with metastatic renal cell carcinoma (mRCC) previously treated with cytokines, according to a new study.

In a phase 3 trial, patients who received axitinib experienced a near doubling of median progression-free survival (PFS) compared with those who received sorafenib, investigators reported at the American Society of Clinical Oncology annual meeting.

“The take-home message is that axitinib is a second-generation TKI [tyrosine kinase inhibitor] that is very active in the treatment of metastatic renal cell carcinoma and should be strongly considered as a standard of care for patients with advanced renal cancer,” said lead study investigator M. Dror Michaelson, MD, Assistant Professor of Medicine at Massachusetts General Hospital Cancer Center in Boston. “It has very impressive efficacy and it generally very well tolerated by the patients.”

He noted that this study is one of the first to compared two TKIs head to head.

Dr. Michaelson and his colleagues presented findings of a subset analysis of mRCC patients who received cytokines as first-line therapy. The researchers enrolled 723 patients with clear-cell mRCC and progressive disease after one systemic therapy. Among these patients, 251 received prior interleukin-2 (IL-2) or interferon-? (IFN-?).  Patients were randomized to receive axitinib (5 mg twice daily starting dose) or sorafenib (400 mg twice daily). The mean age of the patients in the axitinib group was 61 years (range 20-82 years) and 75% were male. The mean age of the patients in the sorafenib group was 60 years (range 35-79 years) and 69% were male.

As of June 2, 2011, the median PFS for cytokine-treated patients was 12.0 months (range 10.1- 13.9) with axitinib versus 6.6 months (range 6.4- 8.3 months) with sorafenib.  For those treated with an IL-2-containing regimen, the median PFS was 15.7 months (range 8.3-19.4) with axitinib versus 8.3 months (range 4.7-15.7 months) with sorafenib.

For those treated with IFN-? alone, the median PFS was 12.0 months (range 10.0 -13.8) with axitinib versus 6.5 months (range 6.4-8.2) with sorafenib. As of November 1, 2011, the median overall survival in the cytokine-treated subgroup was 29.4 months with axitinib compared with 27.8 months with sorafenib.

With respect to adverse events, fatigue, dysphonia, and hypothyroidism were more common with axitinib, whereas hand–foot syndrome, alopecia, and rash were more common with sorafenib.  In all, seven patients (5.6%) previously treated with cytokines discontinued axitinib and nine (7.3%) discontinued sorafenib due to toxicity. Of patients previously treated with cytokines who discontinued treatment with axitinib or sorafenib, 46% in each arm received follow-up systemic therapy.

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DENVER, Jun 04, 2012 (BUSINESS WIRE) -- DaVita Inc. /quotes/zigman/268700/quotes/nls/dva DVA +1.03% , a leading provider of kidney care services that is committed to improving the quality of life for those diagnosed with chronic kidney disease (CKD), today announced the company has chosen five corporate environmental goals for its U.S. operations to be achieved by the end of 2015.

DaVita's U.S. environmental goals are guided by quantifiable 2011 year-end data and will be used to direct reduction in resource consumption and will help communicate DaVita's dedication toward becoming a leader in sustainable health care.

"The environmental goals we set are aggressive, but we believe they are attainable," said Kent Thiry, chairman and CEO of DaVita(R). "Setting far-reaching goals can often create an environment of true innovation, and sometimes that is when we are able to make the biggest impact."

By the end of 2015, DaVita is committed to:

-- Reduce energy consumption by 15 percent per treatment

-- Reduce office paper consumption by 20 percent and operate paperless clinics

-- Reduce water consumption by 10 percent per treatment

-- Increase environmentally preferable procurement by 15 percent

-- Increase teammate awareness/education by implementing one new program a year

More than 3,000 DaVita teammates across the country, from both the clinical and corporate levels, voted to choose the company's environmental goals.

DaVita Village Green(TM) is DaVita's corporate sustainability program that promotes conservation, stewardship and sustainability at offices and facilities across the nation to decrease the company's environmental footprint wherever possible.

DaVita and DaVita Village Green are trademarks or registered trademark of DaVita Inc. All other trademarks are the property of their respective owners.

About DaVita

DaVita Inc., a Fortune 500(R) company, is a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. DaVita strives to improve patients' quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of March 31, 2012, DaVita operated or provided administrative services at 1,841 outpatient dialysis centers located in the United States serving approximately 145,000 patients. The company also operated 15 outpatient dialysis centers located in three countries outside the United States. DaVita supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company's leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu. For more information, please visit www.davita.com .

SOURCE: DaVita

        
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        Ginger Pelz, 303-405-2271 
        
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WEST CONSHOHOCKEN, Pa., June 4, 2012 /PRNewswire via COMTEX/ -- BTG International Inc., the specialist healthcare company, today announces the presentation of data on Voraxaze® (glucarpidase) at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1-5, 2012 in Chicago, Illinois.

BTG received US regulatory approval for Voraxaze® on 17 January 2012, and the data presented formed a key part of the Biologics License Application (BLA) submission.

Clinical data on the compassionate use of Voraxaze® for methotrexate toxicity were presented at the Leukemia, Myelodysplasia, and Transplantation poster session (abstract #6530) on Friday June 1, 2012 from 1 - 5pm. A poster discussion session, presented by Dr. Brigitte Widemann from the National Cancer Institute (NCI), occurred at 4.30pm on the same day.

In the study, 492 patients experiencing renal toxicity and delayed elimination of methotrexate were treated with Voraxaze® (50 U/kg intravenously) in compassionate use trials conducted in the United States and Europe from November 1993 to June 2009. The median age of the patients in the study was 18 years (range:5 weeks to 85 years). 63% were male. 41% had NHL, 30% had osteogenic sarcoma, 23% ALL, and 7% other malignancies. The median pre-Voraxaze® methotrexate concentration was 17 micromoles/litre. 76% of patients received a single dose Voraxaze®, 22% received 2 doses, and 2% received 3 doses. The first dose of Voraxaze® was given at a median of 3 days after methotrexate administration. 156 patients had methotrexate concentrations determined by high performance liquid chromatography (HPLC) assay. At the first measurement (median 15 minutes post-Voraxaze®) serum methotrexate was reduced by a median of 99% relative to the pre- Voraxaze® baseline. At the last measurement (median 40 hours post-Voraxaze®) median serum methotrexate reduction remained at 99% compared with baseline. Among 410 patients with pre-Voraxaze® renal impairment (measured as common terminology criteria for adverse events (CTCAE) Grade 2 or higher), 64% recovered to Grade 0 or 1 after a median of 12.5 days post-Voraxaze®.

Voraxaze® was well-tolerated overall; adverse events included paresthesia (2.0%), flushing (1.8%) and headache (1.0%). 8% of patients died within 30 days of Voraxaze® administration of causes unrelated to Voraxaze®, as judged by the treating physician. Voraxaze® reliably reduced serum methotrexate concentrations by 99% within 15 minutes of administration in patients with impaired renal clearance of methotrexate.

Dr. Brigitte Widemann, MD with the NCI, said: "These data demonstrate that in patients receiving high-dose methotrexate chemotherapy, early recognition of renal dysfunction may warrant intervention with Voraxaze® to reduce serum methotrexate concentrations. Voraxaze® is unique in addressing an unmet medical need in the area of methotrexate-treated cancers."

Guenter R. Janhofer MD, PhD, BTG's Chief Medical Officer and Head of Development commented: "BTG is committed to acute care therapies in oncology, as demonstrated in these data presented at ASCO. This is the first time our comprehensive data, supporting the use of Voraxaze® in adults and children, were presented in a public forum. Voraxaze®, a newly approved therapy, provides a rapid and sustained reduction in plasma methotrexate concentration, helping physicians treat this rare but potentially life-threatening toxicity among patients receiving high-dose methotrexate cancer therapy."

Indication

Voraxaze® (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Voraxaze® is not indicated for use in patients who exhibit the expected clearance of methotrexate or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.

Safety Information

Serious allergic reactions, including anaphylactic reactions, may occur. In clinical trials the most common adverse reactions (incidence >/= 1%) were paresthesias, flushing, nausea and/or vomiting, hypotension and headache.

Healthcare providers should note that:

Methotrexate concentrations within 48 hours following glucarpidase administration can only be reliably measured by a chromatographic method due to interference from metabolites [4-deoxy-4-amino-N10-methylpteroic acid (DAMPA)]. Measurement of methotrexate concentrations within 48 hours of glucarpidase administration using immunoassays can overestimate the methotrexate concentration.

Leucovorin should not be administered within 2 hours before or after a glucarpidase dose because leucovorin is a substrate for glucarpidase.1

Reference

1. Voraxaze® (glucarpidase) prescribing information January 2012

About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The Group is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products. For further information about BTG please visit our website at www.btgplc.com .

SOURCE BTG International Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

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