Major Surgery No Longer Needed For The Removal Of Uterine Fibroids
April 12, 2008
The treatment of uterine fibroids with 3T MR-guided focused ultrasound (MRgFUS) is safe, non-invasive and effective, according to a recent study conducted by researchers at Weill Cornell Medical College in New York, NY.
“Approximately 25% of women in the United States have clinically symptomatic fibroids, and treatment has most commonly been surgical with hysterectomy or myomectomy. However, in the past decade, new options have been developed in radiology, includingnon-invasive MR-guided focused ultrasound (MRgFUS) and minimally invasive uterine artery embolization (UAE) to treat these patients,” said Elizabeth K. Arleo, MD, lead author of the study along with Robert J. Min, MD, MBA, chairman of radiology at Weill Cornell Medical College.
The study evaluated 20 patients who had symptomatic leiomyomas and were treated with 3T MRgFUS. These patients had a pelvic MRI and completed a symptom severity score (SSS) of the uterine fibroid symptom and health related quality of life prior to the procedure and at 6 and 12 months after the procedure.
According to the study, at 6 month follow-up, there was a decrease in SSS (ranging between 10-59%), treated fibroid volume, and total uterine volume. At 12 month follow-up, there was a persistent decrease in SSS (ranging between 15-62%), treated myoma volume, and total uterine volume.
“In contrast to having major abdominal surgery with possible removal of their uterus, a patient can have a safe and effective, totally noninvasive procedure in an outpatient setting without the risks of general anesthesia, no ionizing radiation and a much shorter recovery period,” said Dr. Arleo. “Patients have returned to work as early as one day after MRgFUS, instead of approximately three days after UAE or six weeks after a myomectomy or hysterectomy,” she said.
The full results of this study will be presented on Wednesday, April 16, 2008 during the American Roentgen Ray Society’s annual meeting in Washington, DC.
American Roentgen Ray Society (ARRS)
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University Of Queensland Kidney Researcher Attracts International Medal, Australia
April 10, 2008
University of Queensland researcher Professor Wendy Hoy has been recognised internationally for her work on kidney disease.
Professor Hoy has been awarded the United States National Kidney Foundation (NKF) International Distinguished Medal for 2008 at a ceremony in Dallas, Texas.
The Medal was established to honour the achievement of individuals who have made significant contributions to the field of kidney and related chronic disease.
The Medal recognises Professor Hoy’s research which has helped expand the focus of the renal specialty community from end-stage kidney disease to community-based rates, patterns of disease and risk factors, as well as development of services for early diagnosis and better management. The concepts and approaches can be applied to populations in health and lifestyle transition across the world.
Her projects in Australian Aboriginal populations have helped highlight the high rates of chronic disease in these communities, which she describes as “being of crisis proportions”.
“Widespread application of principles for early detection and prevention within Aboriginal health care are long overdue, as are sustained and reliable funding linked to needs and outcomes,” Professor Hoy said.
This latest international recognition of Professor Hoy’s work comes after she was awarded one of only two prestigious National Health and Medical Research Council (NH&MRC) Australia Fellowships conferred in 2008.
This award is the highest fellowship offered by the NHMRC and recognises excellence in health research.
Professor Hoy was also the recipient of the prestigious American Society of Nephrology (ASN) Barry Brenner Lectureship Award 2007, which acknowledges the contribution of herself and collaborators to new concepts at the cellular level about the nature of susceptibility to renal disease and hypertension.
Among several sources of support for her work has been long-term funding by The Colonial Foundation of Australia, in what is believed to be the largest non-government research grant for Indigenous health research in the nation.
The Foundation has funded Prof Hoy’s research since 2001, including a $1.6m grant over the last three years.
The University of Queensland, Brisbane Australia
Overall Death Due To Kidney Cancer Fall In Europe - But Wide Variations Between Countries Still Exist
April 10, 2008
After peaking in the early 1990s, overall kidney cancer deaths have now dropped across Europe, according to a detailed study of mortality rates for 32 countries. The study is published in the journal BJU International (British Journal of Urology International).
The review is based on official death records collated by the World HealthOrganization from 1984 to 2004.
Male deaths from kidney cancer showed an overall reduction of 13 per cent between1992 and 2002 across the European Union and female deaths fell by 17 per centduring the same period.
Figures for the previous decade had shown a 17 per cent rise for men and an 11 percent rise for women.
Women are significantly less likely to die of kidney cancer than men - between 2000and 2004 the death rate was 1.8 per 100,000 people for women and 4.1 for men.
“It is clear from our study that death rates for kidney cancer peaked in the 1990s andare now showing an overall downward trend” say lead authors Professor Fabio Levifrom the University of Lausanne, Switzerland, and Professor Carlo La Vecchia fromthe University of Milan, Italy.
“However we found wide variations between countries when it came to deaths fromkidney cancer and incidence of the disease.”
The largest reductions in kidney cancer deaths between 1992 and 2002 were inAustria (down 33 per cent for men and 32 per cent for women) and Germany (down31 per cent for both men and women).
When it came to incidence rates, the largest reductions for men between 1992 and2002 were in Sweden (down 18 per cent) and Finland (down 11 per cent) and forwomen in Sweden (down 19 per cent) and Denmark (down 12 per cent).
“Our study confirms that overall kidney cancer rates declined in the 1990s and thatthese decreases have been larger in men, people who are middle-aged and inwestern European countries” says Professor Levi.
“The fall in male deaths is consistent with the links between tobacco usage andkidney cancer risk as men, particularly those from western Europe, are the groupwho have shown the most favourable changes in smoking habits over the last fewdecades.”
There are a number of factors that may play a role in reducing the incidence ofkidney cancer and death rates from the disease.
“Dietary factors might also play some role” says Professor Levi. “Although theirinfluence on kidney cancer remains unclear, some studies have shown that peoplewho eat a diet rich in vegetables and fruit are less likely to develop the disease.”Other factors could include reduced exposure to occupational carcinogens, althoughthe risk of such carcinogens on kidney cancer remains unclear.”
The authors say that there may also be a link with better control of high bloodpressure, a known risk factor for the disease, and better control of urinary tractinfections.
“The current study quantifies recent reductions in kidney cancer deaths and, to alesser degree, the incidence of the disease” concludes Professor Levi.
“But apart from the role played by reduced tobacco smoking in men, interpretation ofthese trends remains open to discussion.”
“The changing pattern of kidney cancer incidence and mortality in Europe.” Levi et al.
BJU International. 101, 949-958 (April 2008).
Click here to view Abstract online
Established in 1929, BJU International is published 23 times a year by Wiley-Blackwelland edited by Professor John Fitzpatrick from Mater Misericordiae University Hospital andUniversity College Dublin, Ireland. It provides its international readership with invaluablepractical information on all aspects of urology, including original and investigative articlesand illustrated surgery. http://www.bjui.org
About Wiley-Blackwell
.Wiley-Blackwell was formed in February 2007 as a result of theacquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger withWiley’s Scientific, Technical, and Medical business. Together, the companies havecreated a global publishing business with deep strength in every major academic andprofessional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewedjournals and an extensive collection of books with global appeal. For more information onWiley-Blackwell, please visit http://www.blackwellpublishing.com orhttp://interscience.wiley.com
OxThera: Pivotal Study Is Being Conducted With Oxabact(TM) For The Treatment Of Primary Hyperoxaluria
April 7, 2008
OxThera announced that all 42 patients have been enrolled in their pivotal phase II/III study using Oxabact™ for the treatment of Primary Hyperoxaluria. Results from this multicenter study will be presented during Q4 of 2008 and be used to file for licensure in EU, US and the rest of the world.
Primary Hyperoxaluria is a rare genetic disease in which excessive oxalate is produced by the liver and excreted in the urine by the kidneys. High levels of urinary oxalate cause kidney stones and/or calcification of the kidney which could lead to kidney failure and in many cases premature death. OxThera estimates that there are about 2000 patients with Primary Hyperoxaluria in EU and US combined.
Oxabact™ consists of a unique intestinal bacterium, Oxalobacter formigenes, naturally colonizing the intestinal tract of most humans with the purpose to degrade oxalate. Previous studies with Oxabact™ have already shown a significant effect in lowering urinary oxalate which in turn leads to a decreased risk of kidney damage. Oxabact™ has been designated orphan drug status in both EU and the US.
The 28 week pivotal study is a randomized, double-blind, placebo-controlled, multi-center study being conducted at eight Primary Hyperoxaluria referral sites in the Netherlands, France, UK, Germany and US.
“Primary Hyperoxaluria is a very serious disease often leading to early kidney failure and in particular systemic oxalate deposition with all its complications including death with no effective medical therapy currently available. For majority of patients the only real option today is a combined liver-kidney transplantation which is available to a very limited number of patients worldwide. Therefore, the Primary Hyperoxaluria community has great hopes that Oxabact™ will offer a new treatment opportunity. A confirmation of earlier study results with Oxabact™ will reflect scientific breakthrough and a new chapter in the treatment of this rare and severe disease”, says Prof. Bernd Hoppe, University Hospital in Cologne, Germany.
Jon Heimer, CEO and President of OxThera comments: “After several years of intensive research on Oxalobacter formigenes and Oxabact™, a significant milestone is met with the inclusion of all patients in this pivotal study. A successful outcome will put us in a position to file for licensure and making the product available to treating physicians and patients during 2009 which is very exciting”.
Short facts about OxThera
OxThera is a biotechnology company active in the development of products for the treatment of metabolic disorders resulting from excess levels of oxalate from endogenous and exogenous sources. Currently, OxThera has two products in its pipeline, Oxabact™ for the treatment of primary hyperoxaluria, and Oxazyme™, for the prevention of recurring calcium-oxalate kidney stones due to secondary hyperoxaluria.
Oxalate is a metabolic end product in humans. It is endogenously produced by the liver and also derived by absorption from the diet. The majority of oxalate is eliminated from the body through the kidneys and a small percentage is eliminated through the GI-tract. Oxalate forms a calcium-oxalate salt which is insoluble at physiological pH and its accumulation can result in serious renal conditions. Consistent high levels of urinary oxalate are known as “hyperoxaluria”, which can result in recurrent kidney stones and renal complications. Hyperoxaluria is currently classified as:
- Primary hyperoxaluria types I and II are rare genetic diseases resulting from overproduction of oxalate in the liver (PH I) or in all body cells (PH II); urinary oxalate excretion is usually greater than 100 mg/day (normal level
- Secondary hyperoxaluria due to excessive absorption of dietary oxalate. This is common in patients with excessive absorption of dietary oxalate and in patients with fat malabsorption due to underlying enteric diseases such as IBD, or cystic fibrosis. Further, it is often seen in patients following jejunoileal bypass surgery or bariatric surgery, and in patients with absorptive hyperoxaluria.
Primary hyperoxaluria is a rare, serious disease with very limited treatment options available. The urinary oxalate excretion rate in affected patients is typically three to six times normal with severe clinical consequences. Kidney stones and/or calcification of the kidney occur in childhood or adolescence. Renal injury due to oxalate and consequences of the stones often leads to renal failure. Loss of renal function, if not addressed promptly by transplantation, leads to markedly increased plasma concentrations of oxalate with deposition of calcium-oxalate in body tissues. Renal failure occurs in 50% of the patients by the age of 15 years and has reached 80% by the age of 30 years. Renal replacement therapy is not able to eliminate sufficient amounts of oxalate, hence systemic oxalate deposition occurs.
OxThera
National Kidney Foundation Introduces Plan To Track Patients In National Screening Program
April 7, 2008
The National Kidney Foundation and Amgen (NASDAQ:AMGN) announced a new initiative of the Kidney Early Evaluation Program (KEEP) that will provide important data to help communities address the growing prevalence of chronic kidney disease (CKD). The initiative introduces a participant follow-up - or “longitudinal” - component to the National Kidney Foundation’s KEEP further strengthening the comprehensive, free kidney disease screening program. The new initiative is made possible by an educational grant from Amgen, KEEP’s primary sponsor.
Offered at community-based locations across the country, KEEP provides comprehensive health risk appraisals to assess individuals’ kidney function and key risk factors for the disease, including high blood pressure and diabetes. The appraisals are based on blood and urine testing as well as onsite physician consultations. The rapidly expanding program is expected to screen approximately 40,000 people in 2008 and recently screened its 100,000th participant since the program’s inception in 2000.
“Most of the 26 million people who are living with CKD in the United States are not even aware that they have it. In fact, our data shows that only two percent of KEEP participants who were diagnosed with CKD knew they were at risk for the disease,” said Joseph Vasalotti, M.D., chief medical officer, National Kidney Foundation. “Early-stage CKD can be difficult to diagnose because symptoms are not usually apparent until the disease progresses to near kidney failure. Yet research shows that treating kidney disease earlier may help improve outcomes. For this reason, the continued expansion and enhancement of KEEP is critical to addressing the public health concerns posed by CKD.”
The new patient follow-up initiative was successfully piloted in Miami, Minneapolis and East Brookfield, Mass. in 2007. It has two primary objectives: first, to assess past KEEP participants and determine improvements in outcomes and, second, to arm community healthcare providers with outcomes data based on participating patients’ ongoing KEEP results from the follow up. KEEP participants, including those who participated prior to the introduction of the follow-up initiative, will be invited back annually for repeat screenings.
The patient follow-up initiative joins an extensive list of recent enhancements to the KEEP program. Among them are:
-Expansion of the physician educational component through an annual data report published in the American Journal of Kidney Diseases and through publication and presentation of KEEP data at medical meetings and in publications targeted at nephrologists, cardiologists and endocrinologists.
-Expansion of KEEP into new geographic regions with a focus on areas with large populations of at-risk individuals, including minorities who have higher incidence of the disease.
-Enhancement of public awareness activities around individual KEEP screenings and for KEEP overall.
-Addition of new tests and protocols to increase KEEP’s impact on national health initiatives including obesity and diabetes.
“Early detection and increased awareness of chronic kidney disease and its causes are essential to helping stem the growing prevalence of the disease that we’ve seen in recent years,” offered U.S. Representative Mark Kirk of Illinois, co-chair of the Congressional Kidney Caucus. “KEEP plays a key role in helping us reach that goal.”
CKD is a condition defined by kidney damage and impaired kidney function that progresses over time. Twenty six million Americans have some form of CKD with minority populations, particularly Hispanics and African Americans, at increased risk for the disease. The most common causes of CKD are high blood pressure, diabetes and a family history of kidney disease. Early-stage CKD often is not diagnosed because symptoms are not usually apparent until the later stages of the disease. When the kidneys fail, dialysis or a kidney transplant is required to sustain life. Dialysis is the artificial process of cleaning wastes from the blood when the kidneys can no longer function adequately.
“KEEP not only represents the seminal screening program for CKD, but it also helps the medical community, state and federal governments and advocacy groups unite to address the growing prevalence of CKD, particularly among minority communities where the need is greatest,” said Robert M. Brenner, M.D., executive director, Nephrology Global Development. “As a pioneer of innovative therapies for patients with complications of chronic kidney disease, Amgen is proud to be the primary sponsor of KEEP.”
About the National Kidney Foundation
The National Kidney Foundation is dedicated to preventing kidney and urinary tract diseases, improving the health and well-being of individuals and families affected by these diseases and increasing the availability of all organs for transplantation. For more information on kidney disease visit http://www.kidney.org.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
Amgen
Affymax And Takeda Report Long-Term Safety And Effectiveness Data Of Hematide In Chronic Renal Failure Patients With Anemia
April 7, 2008
Affymax, Inc. (Nasdaq:AFFY) and Takeda Global Research & Development announced data from their ongoing Phase 2 trial to assess the long-term safety and tolerability of Hematide™, a potential treatment of anemia. These data showed that Hematide, dosed once every four weeks, successfully maintained mean hemoglobin levels between 11 and 12 g/dL for up to 18 months in hemodialysis patients who previously were treated with epoetin alfa. Hematide appeared generally well-tolerated.
Robert Geronemus, M.D., associate professor, Florida Atlantic University and medical director, South Florida Research Institute, is the lead author of the poster which was presented at the National Kidney Foundation 2008 Spring Clinical Meeting.
“These data are encouraging because they demonstrate the ability of Hematide to maintain mean stable hemoglobin levels in these chronic renal failure study participants, while only dosing once every four weeks,” said Dr. Geronemus.
About the Phase 2 Study
81 dialysis patients, originally enrolled in an open-label study to evaluate a switch from epoetin alfa to Hematide, were rolled over to the long-term Phase 2 trial, and then maintained on Hematide for the duration of the follow-up study. The patients received intravenous Hematide once every four weeks for approximately 18 months, totaling 18 doses. Dosing was designed to maintain Hb between 10-12.0 g/dL. In this analysis at 18 months, the mean hemoglobin value was 11.3 g/dL.
Generally, Hematide was well-tolerated in this study. Five patients or 6.2 percent experienced adverse events assessed as possibly related to Hematide, such as diarrhea, feeling hot, insomnia, oedema peripheral, and pain in extremities. Other adverse events were assessed as not related to study drug.
About Hematide
Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).
Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda. Affymax is conducting Phase 3 clinical trials for Hematide to treat anemia associated with chronic renal failure and Takeda is focused on the recently initiated Phase 1 clinical trial in the U.S. to evaluate Hematide to treat chemotherapy-induced anemia in prostate, breast and non-small cell lung cancer patients.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit http://www.affymax.com.
Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., and London, U.K., Takeda Global Research & Development Center, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. Takeda Global Research & Development was established in 2004 and is responsible for Takeda’s clinical research and development in the U.S. and Europe, supporting clinical and product development activity for Takeda commercial organizations in the U.S. - Takeda Pharmaceuticals North America, Inc, and in Europe: six sales and marketing companies, respectively. With a robust pipeline of compounds in development for diabetes, cardiovascular disease and other conditions, Takeda rapidly brings innovative products to market to improve patient health and enhance the practice of medicine. To learn more about the company, visit http://www.tgrd.com.
This release contains forward-looking statements, including statements regarding the success of the collaboration, timing, design and results of the Companies’ clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Companies’ actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in Affymax’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Companies undertake no obligation to update any forward-looking statement in this press release.
Affymax, Inc.
A Large Open Label, Non-Comparative, Phase III Study Of The Multi-Targeted Kinase Inhibitor Sorafenib In European Patients
April 6, 2008
UroToday.com - Dr. Verzoni presented a trial to collect safety and efficacy data on sorafenib from a large and broad study population reflecting clinical practice. This nonrandomized, open-label study included male and female patients, aged ≥18, with an ECOG PS 0 2 and a life expectancy >2 months. Patients had to be unsuitable for or have failed prior cytokine therapy. Controlled, asymptomatic brain metastases were allowed. Patients received continuous therapy with sorafenib 400 mg twice daily until disease progression, intolerable toxicity, or withdrawal of consent. Dose increases were not permitted. Recruitment was planned to continue until regulatory approval of sorafenib for advanced RCC. Study assessments were conducted at baseline and then monthly. Adverse events were graded according to NCI CTCAE v 3.0 criteria. Tumor assessment and radiological evaluation were conducted within 28 days prior to the start of sorafenib therapy, and then according to local standards of care, but at least every 3 months.
A total of 1155 patients were recruited in 11 European countries. Seventy-five percent of patients were male. Median age at enrollment was 62 years. At baseline, ECOG PS = 0 in 40% of patients, 1 in 45%, and 2 in 15%; 73% of patients had tumor lesions in the lungs, 41% in lymph nodes, 36% in bone, 28% in the liver and 23% in the kidneys. Eleven percent of patients had not had the primary tumor resected. Twenty-eight percent of patients had no prior therapy and were included because they were unsuitable for cytokine treatment. Tumor histology included pure clear cell (75%), papillary (10%) and chromophobe (3%) subtypes. Sarcomatoid features were noted in tumor samples from 5% of the patients. Most frequent Grade ≥3 drug-related adverse events were hand-foot-skin reaction [12%], fatigue [8%], diarrhea [5%], rash/desquamation [5%] and hypertension [4%]. The rates of Grade ≥3 drug-related adverse events were similar across sub-populations evaluated. The median progression-free survival was 6.8 months, and the median duration of treatment 6.9 months.
This EU-ARCCS study successfully provided treatment to a large number of patients with RCC across Europe prior to regulatory approval. EU-ARCCS confirmed the safety findings of the TARGET study in a real life setting and in clinically relevant patient sub-populations. The efficacy of sorafenib appears to be comparable with that observed in randomized controlled clinical trials.
Presented by: E. Verzoni, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
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Safety And Short-Term Efficacy Of Laparoscopic Cryoablation For Renal Tumors ≥ 3 Cm: A Multicenter European
April 6, 2008
UroToday.com - A multicenter European group reported on the short-term outcomes of laparoscopic cryoablation for renal lesions greater than 3cm in size. Laparoscopic cryoablation has previously been reported as safe and effective for renal tumors
Patients’ data at 7 European centers was prospectively recorded. Procedures were carried out laparoscopically using laparoscopic ultrasound guidance and 17g cryo-needles or Ice Rods. A total of 80 tumors at least 3cm in size (median 3.6) were treated over a 4 year period. Over 80% of the patients had significant comorbidity and were not considered good candidates for partial or radical nephrectomy. Twenty-five percent had a single functioning kidney.
A total of 20 peri-operative complications occurred in 18 of 80 patients (22.5%); 7 major and 13 minor. Major intra-operative complications included 1 nephrectomy and 2 partial nephrectomies for bleeding. Post-operatively, there was 1 hematoma requiring transfusion and 3 myocardial infarctions resulting in one death. Minor complications included chest infection (1), wound infection/hematoma (4), skin burn (1), fever (1), UTI (2) and ileus (4). Only 2 patients required transfusions. Overall, 4 major bleeding complications occurred in the 80 cases (5.0%) and the researchers stated that these could potentially be attributed to the large tumor size.
The conclusion was that peri-operative complications for laparoscopic renal cryoablation are higher in patients with tumors larger than 3 cm; however, major bleeding complications remain relatively uncommon with 17g needles. The emphasis was that more care must be taken not to traumatize the ice ball during treatment, especially in exophytic tumors. Technical tips included freezing to a target of -40 to - 60C and no lower, which may prevent cracking and resultant bleeding complications.
Presented by: F.X. Keeley, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
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Laparoscopic Renal Cryoablation (LRC) Of Small Renal Masses
April 6, 2008
UroToday.com - A group from Milan, Italy prospectively analyzed the outcome of patients with kidney masses treated with laparoscopic cryoablation over a 7-year period. Beginning in September 2000, 104 patients (mean age 61.6 years; 78 male and 26 female) underwent LRC for renal masses. The mean lesion diameter was 2.2cm. The procedure was performed transperitoneally in 60 cases and in 44 patients it was done retroperitoneoscopically, based upon the tumor position or potential difficulties due to previous abdominal surgery. Fifty-six patients (54%) had concomitant comorbidities.
The intra-operative mean diameter of the ice ball was 4.93cm. All the procedures were successfully completed laparoscopically, except 3 cases that were converted to open surgery, two of them due to bleeding from the site of the cryoprobe insertion (one of them requiring radical nephrectomy). Mean surgical time was 202.6min (range 90-320 min) and mean intra-operative blood loss was 211.6 cc (range 10-3.200 cc). Pathological evaluation of the intra-operative needle biopsies documented renal cell carcinoma in 64 cases, 23 oncocytomas, 6 angiomyolipomas, 1 case of Xantogranulomatous pyelonephritis and 10 cases “undefined” disease. Post-operative stay was 4.7 days (range 2-13). Postoperative complications were always treated conservatively and included 7 cases of transient fever, 2 cases of small peri-renal hematomas, 1 case of pulmonary edema, 9 patients with significant blood loss and 1 case of gross hematuria. Delayed complication included 1 case of UPJ obstruction requiring open pyeloplasty 8 months after surgery and open nephrectomy one year after surgery due to suspected recurrence of the disease. Six patients died during the follow-up, 5 due to previous illness and 1 patient due to worsening cirrhosis one month after surgery. No patients died secondary to renal cancer.
MRI scans on postoperative day one revealed a mean lesion of 4.91cm. Progressive reduction in size of the ablated lesion was visible in all patients with only a renal scar visible after 24 months of follow-up. This remained constant over time with 36 patients being followed up for 5 years and 11 patients for 7. In the question period, Dr. Jewett (Toronto) pointed out that 40% of the patients with benign lesions had unnecessary treatment and perhaps the biopsies should be performed a few weeks prior to the intended procedure.
Presented by: A. Cestari, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
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Management Of Superficial Bladder Tumors: Does Photo Dynamic TURB Improve Outcome Of Initial T1 High Grade Bladder Cancer?
April 6, 2008
UroToday.com - Long-term Follow-up of a Randomized Study
Studies have shown that 5-aminolevulinic acid (5-ALA) induced fluorescence cystoscopy improves the detection of superficial bladder cancer. The results suggest a reduced rate of recurrent tumors with the use of 5-ALA fluorescence technique prior to bladder tumor resection. On behalf of a group of German investigators, Dr. Burger presented a prospective, randomized trial to investigate whether the long-term tumor recurrence and residual tumor rate can be decreased by fluorescence diagnosis.
A total of 301 patients with suspected superficial bladder carcinoma were randomized to transurethral resection (TUR) under conventional white light (WL) or fluorescence diagnosis (FD). Transurethral resection was repeated to evaluate the residual tumor rate. In addition, patients were followed for a median of 83 (WL) and 86 (FD) months to evaluate recurrence-free survival (RFS).
At analysis, 191 patients were available for efficacy analysis. The residual tumor rate was 25.2% in the WL arm versus 4.5% in the FD arm (p
Dr. Burger concluded that ALA-induced FD is statistically significantly superior to conventional WL TUR with respect to both residual tumor rate and recurrence free survival. He stated that this advantage of decreased bladder tumor recurrence risk is maintained with high statistical significance for at least 8 years. The differences in RFS imply that FD offers a clinically relevant procedure to reduce the number of tumor recurrences. Burger M., Stief C., Zaak D., R??ler W., Wieland W-F., Filbeck T., Knüchel R., Denzinger S.
Presented by: M. Burger, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
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