1. EMBARGOED FOR RELEASE UNTIL May 15, 2011 AT 2:00 P.M.
Contact: Wendy Waldachs Isett, AUA
410-977-4770, wisett@AUAnet.org
RESEARCHERS STUDY OPTIONS IN TREATING KIDNEY CANCER
Panel to address active surveillance, nephron-sparing vs. radical nephrectomy
Washington, DC -- May 15, 2010– Several new studies that examine clinical benefits in the rates of
partial vs. radical nephrectomies and the usefulness of active surveillance for patients with small renal
masses (SRMs) will be presented to reporters during a special press conference at the Walter E.
Washington Convention Center on Sunday, May 15, 2011 at 2 p.m. EDT during the 106th Annual
Scientific Meeting of the American Urological Association (AUA). The media session will be moderated
by Jeffrey Holzbeierlein, MD.
Characteristics of Small Renal Masses Progressing To Metastases While Under Observation: A
Pooled Analysis (#1663): Active surveillance (AS) for SRMs has emerged as an alternative to surgical
therapy for some patients with kidney cancer. In this study, researchers from the Fox Chase Cancer
Center in Philadelphia reviewed a pooled analysis of studies that investigated the natural history of
SRMs with an emphasis on measuring tumor growth rates and the clinical characteristics of the lesions
that progressed to metastatic cancer. They found that in a majority of cases, the SRMs exhibited slow
growth rates with a low short-term risk of becoming metastatic cancer. A small proportion of SRMs
did advance.
The cases of 880 patients/936 SRMs were reviewed. Mean tumor size ranged from 1.7 – 7.2 cm. 32.5
percent of all lesions exhibited zero net growth over time and did not metastasize. However, 18 cases
– 2.1 percent – did grow to metastatic cancer. However, while they were considered late events,
advancing disease may have been related to increased age, initial tumor size and volume, linear
growth rate and volumetric growth, which may need to be considered in addition to radiographic data
in order to optimally predict progression.
Partial Nephrectomy vs. Radical Nephrectomy For Non-Metastatic Renal Cell Carcinoma: Utilization
Trends In The United States (#540): Removing only the cancerous portion of the kidney – partial
nephrectomy, or PN – has benefits over total organ removal – radical nephrectomy, or RN – not the
least of which is maintenance of kidney function. However, in this study conducted in the University of
Montreal Health Center in Montreal, QC, researchers tested the theory that PN remains underutilized
in North America.
The researchers examined the Nationwide Inpatient Sample and performed a retrospective cohort
analysis of 48,321 patients with non-metastatic renal cell carcinoma (RCC) during the time period.
Overall, PN was performed in 18 percent of the patients, and increased over time from 7 percent in
1998 to 26 percent in 2007. Over the course of the study decade (1998-2007), the rate of PN increased
nearly four-fold. However significant variability was found, with higher rates of PN associated with
intermediate- and high-volume institutions and contemporary year of surgery. Likewise, certain
patients, a decreased rate of PN was found in octogenarians as well as in female and patients of
Hispanic race. Non-academic institutions were also associated with a decreased use of PN.
2. The Overuse Of Nephron-Wasting Radical Nephrectomy In The Elderly: An Analysis of Trends In The
United States Population from 1998 – 2007 (#1668): In a similarly themed study conducted by the
Columbia University College of Physicians and Surgeons, researchers compared the rates of PN to RN
in elderly patients. They found that RN is performed more often than PN in patients 75 and older,
despite the fact that this patient group often has multiple comorbid conditions and are likely to
benefit from nephron-sparing surgery. Using data from the Surveillance, Epidemiology and End Results
(SEER) registry, the researchers identified 18,045 cases of localized Renal Cell Carcinoma of four
centimeters between 1998 and 2007. The compared two groups: those over age 75 and those below
age 75. Overall, 66 percent of patients over 75 underwent RN, compared to 59 percent of patients
below age 75. Of those with smaller tumors, the disparity was even more pronounced.
Has A Minimally Invasive Approach Become More Important Than Nephron Preservation In The
Management Of The Clinically Localized Renal Mass? (#66): Researchers from the Fox Chase Cancer
Center in Philadelphia, PA examined the impact of laparoscopy on rates of nephron-sparing
techniques from 1995-2005. They found that growth rates in the laparoscopic radical nephrectomy
(LRN) were rising faster than partial nephrectomy, which they deemed a cause for concern. Even
though it is conducted through a less invasive procedure than open partial nephrectomy (OPN), LRN
still results in removal of the entire kidney. Meanwhile, recent evidence suggests that nephron-sparing
surgery reduces the risk of chronic kidney disease and may improve survival rates in patients with
kidney cancer. Using SEER-Medicare data, authors examined national trends in rates of open radical
nephrectomy, LRN and OPN as well as laparoscopic partial nephrectomy (LPN) in patients with
localized, stage one and stage two renal masses from 1995-2005 (6,716 patients).
They found that during that time period, the number of patients receiving ORN, decreased from 86.7
percent to 36.4 percent. While there were increases in the utilization rates of OPN (6.7 percent to 13.5
percent) and LPN (.6 percent to 9.3 percent), this was offset by an even bigger growth of LRN over the
same time period (6.1 percent to 40.8 percent). As a result, utilization of nephron-sparing techniques
increased by only 15.5 percent during the 10-year study period, while 77 percent of patients with
localized tumors still underwent radical nephrectomy as recently as 2005.
“In recent years, we’ve moved further away from radical nephrectomy to treat small renal masses and
have adopted a nephron-sparing approach in order to preserve kidney function and potentially
prevent future kidney-related comorbidities such as diabetes and high blood pressure,“ said AUA
spokesperson Jeffrey M. Holzbeierlein, MD. “Though progress is being made in terms of educating
physicians about what can be done to preserve kidney function, many still have not adopted a
nephron-sparing approach.”
NOTE TO REPORTERS: Experts are available to discuss this study outside normal briefing times. To
arrange an interview with an expert, please contact the AUA Communications Office at the number
above or e-mail Communications@AUAnet.org.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the
American Urological Association is the pre-eminent professional organization for urologists, with more than
17,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of
fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their
patients.
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3. 1663
CHARACTERISTICS OF SMALL RENAL MASSES PROGRESSING TO METASTASES WHILE UNDER
OBSERVATION: A POOLED ANALYSIS
Marc Smaldone, Alexander Kutikov, Brian Egleston, Daniel Canter, Rosalia Viterbo, David Chen,
Richard Greenberg, Robert Uzzo, Philadelphia, PA
INTRODUCTION AND OBJECTIVES: Active surveillance (AS) for small renal masses (SRMs) has emerged
as an alternative to surgical therapy in select patients. We conducted a systematic review and pooled
analysis of studies investigating the natural history of SRMs under observation with an emphasis on
tumor growth kinetics and clinical characteristics of lesions progressing to metastases.
METHODS: A MEDLINE search was performed to identify all clinical series reporting observation of
suspected renal malignancies. We extracted demographic, clinical, and pathologic variables for SRMs
progressing to metastases and those who did not. For studies reporting individual level data,
comparisons were performed using Wilcoxon rank-sum tests.
RESULTS: A total of 18 series met screening criteria (all ?level III evidence), of which individual level
data was available for pooled analysis in 6 studies. Systematic review revealed 880 patients (936
SRMs) with mean initial tumor sizes ranging from 1.7-7.2 cm. These lesions demonstrated mean linear
growth rates ranging from 0.1-0.7cm/year over observation periods ranging from 15-47.6 months.
32.5% of all lesions exhibited zero net growth over time; of this sub-cohort, no SRM progressed to
metastasis. Eighteen cases (2.1%) progressing to metastasis were identified. Pooled analysis
comparing progressors and non-progressors (N=282) revealed significant trends including increased
age (75.1 vs. 66.6 years, p=0.026), initial tumor size (4.3 vs. 2.3 cm, p<0.0001) and volume (70.0 vs.
18.1cm3, p=0.0001), linear growth rate (0.8 vs. 0.3cm/yr, p=0.0004), and volumetric growth rate (27.4
vs. 6.5 cm3/yr, p<0.0001) in the progression cohort.
CONCLUSIONS: Our systematic review and pooled analysis support that the majority of SRMs under
radiographic surveillance exhibit slow growth kinetics with a low short term risk of metastatic
progression. However, while generally late events, a small proportion of SRMs under surveillance
demonstrate evidence of progression, and the prediction of their natural growth history cannot be
reliably determined by serial radiographic data alone. Utilizing available parameters, lesions that
exhibit zero growth over time may represent a population appropriate for prolonged AS while positive
growth rates self select for delayed intervention. In the absence of level I evidence, while it appears
that observation of SRMs may be delayed without negative sequelae in patients with objectified
competing risks, AS should not be considered an equivalent alternative to definitive surgical therapy in
acceptable operative candidates.
Source of Funding: Kidney Cancer Keystone Program
4. 540
PARTIAL NEPHRECTOMY VERSUS RADICAL NEPHRECTOMY FOR NON-METASTATIC RENAL CELL
CARCINOMA: UTILIZATION TRENDS IN THE UNITED STATES
Maxine Sun, Claudio Jeldres, Firas Abdollah, Daniel Liberman, Jan Schmitges, Orchid Djahangirian,
Monica Morgan, Salima Ismail, Kevin Zorn, Shahrokh F. Shariat, Paul Perrotte, Pierre I Karakiewicz,
Montreal, Canada
INTRODUCTION AND OBJECTIVES: Partial nephrectomy (PN) has several important advantages over
radical nephrectomy (RN) in the management of renal cell carcinoma (RCC). The advantage hinges on
the preservation of renal function and its long-term effects. Several previous investigators suggested
that PN remains relatively underutilized in North America. We examined this hypothesis in a
population-based analysis.
METHODS: We examined the Nationwide Inpatient Sample and performed a retrospective cohort
analysis of 48321 patients with non-metastatic RCC treated with PN or RN between years 1998 and
2007. We examined the utilization rates of PN and RN throughout the study period, as well as the
patient characteristics, in-hospital mortality, and length of stay. Finally we assessed the determinants
of PN use using logistic regression models.
RESULTS: Overall, PN was performed in 8551 patients (18%). The rate of PN increased over time: from
7% in 1998 to 26% in 2007 (P<0.001). Patients treated with PN were on average younger relative to RN
patients (mean: 60 vs. 63, P<0.001) and had lower baseline Charlson Comorbidity Index [CCI] (CCI 0: 64
vs. 62%, P<0.001). A higher proportion of PN patients were treated at academic (69 vs. 52%, P<0.001)
and high-volume (46 vs. 31%, P<0.001) institutions. Laparoscopic procedure was performed less
frequently in PN patients (6 vs. 9%, P<0.001). The rate of in-hospital mortality (0.4 vs. 0.8%, P<0.001)
and the proportion of patients with a length of stay above the median (45 vs. 50%, P<0.001) was lower
in PN patients. After adjusting to all variables, octogenarians (odds ratio [OR]: 0.5, P<0.001), female
gender (OR: 0.9, P=0.008), Hispanic race (OR: 0.8, P=0.02), CCI?4 (OR: 0.7, P<0.001), and non-academic
institutions (OR: 0.6, P<0.001) were associated with a decreased use of PN. In contrast, intermediate-
(OR: 1.2, P<0.001) and high-volume institutions (OR: 1.6, P<0.001), as well as more contemporary year
of surgery (2005?2007 OR: 2.0, P<0.001) were associated with a higher odds of undergoing PN.
CONCLUSIONS: The rate of PN increased nearly 4-fold over the study decade, which represents a
favorable result. It is of concern that important variability in PN rates exists with respect to hospital
and patient characteristics. Some of these characteristics (e.g. high hospital volume, female gender,
Hispanic race) could undermine access to PN and warrant closer examination within institutions where
nephrectomies are performed.
Source of Funding: none
5. 1668
THE OVERUSE OF NEPHRON-WASTING RADICAL NEPHRECTOMY IN THE ELDERLY: AN ANALYSIS OF
TRENDS IN THE UNITED STATES POPULATION FROM 1998-2007
Max Kates, Gina Badalato, Max Pitman, Arindam RoyChoudhury, James McKiernan, New York, NY
INTRODUCTION AND OBJECTIVES: Over the past 10 years, partial nephrectomy has become the
standard of care for small renal masses. Elderly patients, often with multiple comorbid conditions, are
likely to benefit from nephron-sparing surgery, yet surgeons may be hesitant to perform a more
complex, lengthy procedure in this older cohort. We analyzed the utilization of radical nephrectomy
(RN) and partial nephrectomy (PN) over a 10 year period in patients ?75 years old compared to their
younger counterparts.
METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) registry, we identified 18,045
cases of localized Renal Cell Carcinoma (RCC) ?4cm diagnosed between 1998 and 2007. Baseline
differences in demographic and tumor characteristics were compared between the two age cohorts
(<75 vs. ?75), and rates of RN were determined, stratified by tumor size. A multivariate logistic
regression model was then fitted to predict the odds of receiving a radical nephrectomy for clinical
T1a disease.
RESULTS:
Overall 2,733 (15%) patients were
?75 years old. On univariate analysis,
elderly patients were more likely to
be Caucasian, female, and have
slightly larger tumors (2.9cm vs
2.7cm, p<0.001 for all). The use of
radical nephrectomy in all patients
decreased over the study period
(79% in 1998 to 49% in 2007).
Overall, 66% of patients ?75 yrs
underwent RN for their disease,
compared to 59% of patients <75 yrs
(p<0.001). The disparity in use of RN
between the two age groups was
most pronounced for patients with
the smallest tumors, such that 51%
of patients ?75 yrs with tumors ?2 cm underwent RN, compared to 41% in the younger cohort (see
figure). In a multivariate logistic model controlling for gender, race, tumor size, Fuhrman grade, and
year of diagnosis, age?75 independently predicted the use of radical nephrectomy (OR: 1.18; 95% CI:
1.08-1.29). A 1 year increase in age was associated with a 1% increase in risk of undergoing RN
(OR:1.01; 95% CI: 1.01-1.01).
CONCLUSIONS: Elderly patients with clinically localized small renal masses receive RN more often than
younger patients. Further studies should address the medical implications of the selective use of
radical surgery within the geriatric population
Source of Funding: The Doris Duke Charitable Foundation
6. 66
HAS A MINIMALLY INVASIVE APPROACH BECOME MORE IMPORTANT THAN NEPHRON
PRESERVATION IN THE MANAGEMENT OF THE CLINICALLY LOCALIZED RENAL MASS?
Marc Smaldone, Alexander Kutikov, Brian Egleston, Daniel Canter, Ervin Teper, Rosalia Viterbo, David
Chen, Richard Greenberg, Robert Uzzo, Philadelphia, PA
INTRODUCTION AND OBJECTIVES: The AUA guidelines for the management of localized renal masses
highlight the importance of oncologic efficacy, nephron preservation, and the use of minimally
invasive techniques when appropriate. Using SEER-Medicare data we examined the impact of
laparoscopy on utilization of nephron sparing techniques from 1995-2005.
METHODS: Using linked SEER-Medicare data, we examined national trends in utilization of open
radical nephrectomy (ORN), laparoscopic radical nephrectomy (LRN), open partial nephrectomy (OPN),
and laparoscopic partial nephrectomy (LPN) in patients with localized (stage I/II) renal masses from
1995-2005. Linked data was not available after 2005. Data were analyzed using ANOVAs, chi-squared
tests, and logistic regression analysis.
RESULTS: 6,716 patients (mean age 74.2±5.7 years, 53.4% male) who underwent surgery for clinically
localized tumors (mean tumor size of 4.8±3.2cm) were identified. Comparing patients undergoing
ORN, LRN, OPN, and LPN, significant differences were observed in age (p<0.001), gender (p=0.01),
tumor stage (p<0.001), and tumor size (p<0.001). When evaluated over time, the rates of ORN
decreased while for each year successive year, patients were more likely to be treated with OPN (OR
1.18, CI 1.14-1.21), LRN (OR 1.44, CI 1.40-1.48) and LPN (OR 1.68, CI 1.56-1.81). Comparing utilization
trends in 1995 and 2005, there was a marked reduction in number of patients undergoing ORN (86.7%
vs. 36.4%, p<0.001). However, while the increased utilization of OPN (6.7% vs. 13.5%, p=0.001) and
LPN (0.6% vs. 9.3%, p<0.001) reached statistical significance, this was offset by a marked increase in
LRN over the same time period (6.1% vs. 40.8%, p<0.001). As a result, utilization of nephron sparing
techniques increased by only 15.5% over the ten year period, with 77% of identified patients with
localized tumors still managed with radical nephrectomy in 2005.
CONCLUSIONS: Recent evidence suggests that nephron sparing surgery reduces the risk of chronic
kidney disease and may impact survival in patients with renal cell carcinoma. While rates of ORN for
clinically localized renal masses have decreased by 50% since 1995 there has been a two fold rise in
the utilization of LRN when compared to partial nephrectomy. The trade off of minimally invasive
surgery for nephron preservation may have adverse long term consequences.
Source of Funding: Kidney Cancer Keystone Program