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MP54-05 MENTAL HEALTH NOT AFFECTED BY ACTIVE SURVEILLANCE FOR PATIENTS WITH SMALL RENAL MASSES: QUALITY OF LIFE RESULTS FROM THE DISSRM (DELAYED INTERVENTION AND SURVEILLANCE FOR SMALL RENAL MASSES) REGISTRY
THE JOURNAL OF UROLOGYâ
Vol. 191, No. 4S, Supplement, Monday, May 19, 2014
exaggerated on the first AS image based on the fact that small changes in growth over a short interval can produce rapid GR. Clinicians should use early growth kinetics cautiously and temper their recommendation for intervention in the initial phase of AS to prevent overtreatment. Number Images
Mean GR (cm/year)
Standard Deviation
% Progression
336
0.19
0.93
22.0
< 183 Days
71
0.52
1.81
37.1
183-365
78
0.13
0.66
18.2
365-730
94
0.07
0.40
>¼730
93
0.12
0.31
Entire Cohort
6.52 10.9
Source of Funding: National Comprehensive Cancer Network (NCCN)
MP54-04 PARTIAL NEPHRECTOMY IS EQUIVALENT TO ACTIVE SURVEILLANCE IN PRESERVING RENAL FUNCTION FOR PATIENTS WITH SMALL RENAL MASSES Matthew Danzig*, Rashed Ghandour, Srinath Kotamarti, Tina Schubert, Arindam RoyChoudhury, New York, NY; Phillip Pierorazio, Baltimore, MD; Ketan Badani, New York, NY; Mohamad Allaf, Baltimore, MD; James McKiernan, New York, NY INTRODUCTION AND OBJECTIVES: Active surveillance (AS) for patients with a small renal mass (SRM) is considered an acceptable alternative to surgery due to the slow growth of such tumors, low risk of metastasis, and presumed retention of renal function. We previously demonstrated a moderate decline in renal function for patients on AS in the Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry. We now sought to compare this with the decline following extirpative modalities. We also correlated tumor growth rate with renal functional decline in AS patients. METHODS: The multi-institutional DISSRM Registry opened January 1, 2009. Patients with SRMs 4cm were entered into AS or intervention arms. Those electing AS followed an imaging protocol. Growth rates of masses were calculated based on changes in diameter. GFR was calculated with the Modification of Diet in Renal Disease formula. GFR change was calculated from the first value for surveillance patients or the pre-operative value for intervention patients, to the most recent value. Linear regression was used to determine the effects of study arm and growth rate on GFR, while controlling for the impact of demographics, comorbidities, and tumor histology. RESULTS: The difference in average GFR decline between the 66 partial nephrectomy (PN) patients and the 67 AS patients was not significant (1.9 vs 0.5, p¼0.270). In contrast, there was a significantly greater decline in the 15 radical nephrectomy (RN) patients compared to the AS patients (9.2 vs 0.5, p¼0.001). Average follow up time for AS, PN, and RN patients was 20, 19, and 16 months, respectively. On regression analysis while controlling for comorbidities, GFR was again found to decline faster in RN (p¼0.016) but not PN (p¼0.778) patients compared to AS patients. Average growth rate of masses in the AS arm was 0.19 cm/year. There was no significant difference in GFR change between AS patients whose tumors increased in size over their enrollment and those whose tumors decreased in size, as shown in the table (p¼0.260). On regression analysis the tumor growth rate did not significantly affect the rate of GFR decline while controlling for comorbidities (p¼0.915). CONCLUSIONS: AS for the small renal mass yields equivalent preservation of GFR when compared to PN, while both modalities are superior to RN. Preservation of renal function during AS is unaffected by growth rate. These renal function outcomes should be considered when making treatment decisions.
e573
N
GFR Declined
No change in GFR
GFR Rose
Surveillance
67
31 (46%)
10 (15%)
26 (39%)
Partial Nephrectomy
66
38 (57%)
9 (13%)
20 (30%)
Radical Nephrectomy
15
13 (87%)
0 (0%)
2 (13%)
Within Surveillance: Tumor increased in size
42
7 (41%)
5 (29%)
5 (29%)
Tumor decreased in size
17
20 (48%)
5 (12%)
17 (40%)
Source of Funding: National Comprehensive Cancer Network (NCCN)
MP54-05 MENTAL HEALTH NOT AFFECTED BY ACTIVE SURVEILLANCE FOR PATIENTS WITH SMALL RENAL MASSES: QUALITY OF LIFE RESULTS FROM THE DISSRM (DELAYED INTERVENTION AND SURVEILLANCE FOR SMALL RENAL MASSES) REGISTRY Phillip Pierorazio, Michael Gorin*, Baltimore, MD; Matthew Danzig, Rashed Ghandour, New York, NY; Peter Chang, Robert Hartman, Andrew Wagner, Boston, MA; James McKiernan, New York, NY; Mohamad Allaf, Baltimore, MD INTRODUCTION AND OBJECTIVES: Quality-of-life (QOL) measures have not been evaluated in a rigorous fashion for patients undergoing active surveillance (AS) for small renal masses (SRM). The prospective, multi-institutional Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry was opened January 1, 2009, enrolling patients with SRM 4.0 cm who chose intervention or AS. METHODS: Patients were enrolled following consultation and choice of AS or intervention. Those electing AS followed an imaging protocol every 4-6 months for 2 years, then every 6-12 months for 3 years. SF12 QOL questionnaires were completed at enrollment, at 6 and 12 months, and annually thereafter. Mental Component Summary (MCS), Physical Component Summary (PCS) and overall score were evaluated among groups and over time with analysis of variance and linear regression modeling. RESULTS: At 57 months, among 4 institutions, 438 patients are enrolled: 177 elected AS, 261 primary intervention. 970 questionnaires have been completed at a mean of 12.5 months (0-48). QOL Scores are demonstrated in the Table. Among groups, intervention had significantly higher differences in total score at enrollment (p¼0.003) and 1-year (0.04). In PCS, intervention scores were higher at enrollment, 6 months and 1 and 2 years (p<0.045); there were no differences in MCS at any timepoint. A small increase in total score (coefficient 0.165, p¼0.04) and MCS (0.132, 0.005) were noted in the AS cohort over time; a very small increase in MCS was noted in the intervention cohort (0.067, 0.026). CONCLUSIONS: In a prospective registry of patients undergoing AS or immediate intervention for SRM, patients undergoing immediate intervention have higher QOL scores at baseline - specifically in domains that reflect their physical health. The perceived benefit in physical health persists for at least two years following intervention. Mental health, which includes domains of depression and anxiety, is not adversely affected while on AS. N Active Surveillance
SF12
MCS
PCS
Score
Range
Score
Range
Score
Range
50.8
11.4-66.5
40.7
20.1-62.2
Enrollment
89
92
47.9-114.7
6 months
60
95.9
62.7-116
56.1
34.2-65.5
40.9
12.9-57.9
1 year
43
94.7
59.7-114.7
55.1
22.6-64.8
42.0
21.7-57.2
2 year
31
95.4
66.5-114.7
55.2
24.1-26.9
42.2
22.5-57.9
3 year
20
98.9
66.1-116
57.45
34.7-68.4
41.1
16.5-57.5
4 year
13
99.7
75.7-114.6
59.5
41.5-63.3
42.4
23.7-55.3
Score
Range
Score
Range
Score
Range
Intervention Enrollment
225
100.7
47.9-117.4
52.5
22.8-69.7
50.7
20.3-64.8
6 months
151
105.4
50.7-117.4
55.5
13.5-69.3
50.2
18.6-63.5
1 year
137
106.1
51.5-117.4
55.9
17.5-66.4
51.2
21.4-64.2
2 year
101
104.5
54.8-117.4
56.7
20.8-66.9
49.0
20.8-61.7
3 year
69
99.4
55.8-117.4
56.0
24.2-63.8
44.2
18.7-58.9
4 year
31
97.8
47.1-117.4
52.9
17.6-61.2
50.7
5.38-59.3
Source of Funding: National Comprehensive Cancer Network (NCCN)
Vol. 191, No. 4S, Supplement, Monday, May 19, 2014
exaggerated on the first AS image based on the fact that small changes in growth over a short interval can produce rapid GR. Clinicians should use early growth kinetics cautiously and temper their recommendation for intervention in the initial phase of AS to prevent overtreatment. Number Images
Mean GR (cm/year)
Standard Deviation
% Progression
336
0.19
0.93
22.0
< 183 Days
71
0.52
1.81
37.1
183-365
78
0.13
0.66
18.2
365-730
94
0.07
0.40
>¼730
93
0.12
0.31
Entire Cohort
6.52 10.9
Source of Funding: National Comprehensive Cancer Network (NCCN)
MP54-04 PARTIAL NEPHRECTOMY IS EQUIVALENT TO ACTIVE SURVEILLANCE IN PRESERVING RENAL FUNCTION FOR PATIENTS WITH SMALL RENAL MASSES Matthew Danzig*, Rashed Ghandour, Srinath Kotamarti, Tina Schubert, Arindam RoyChoudhury, New York, NY; Phillip Pierorazio, Baltimore, MD; Ketan Badani, New York, NY; Mohamad Allaf, Baltimore, MD; James McKiernan, New York, NY INTRODUCTION AND OBJECTIVES: Active surveillance (AS) for patients with a small renal mass (SRM) is considered an acceptable alternative to surgery due to the slow growth of such tumors, low risk of metastasis, and presumed retention of renal function. We previously demonstrated a moderate decline in renal function for patients on AS in the Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry. We now sought to compare this with the decline following extirpative modalities. We also correlated tumor growth rate with renal functional decline in AS patients. METHODS: The multi-institutional DISSRM Registry opened January 1, 2009. Patients with SRMs 4cm were entered into AS or intervention arms. Those electing AS followed an imaging protocol. Growth rates of masses were calculated based on changes in diameter. GFR was calculated with the Modification of Diet in Renal Disease formula. GFR change was calculated from the first value for surveillance patients or the pre-operative value for intervention patients, to the most recent value. Linear regression was used to determine the effects of study arm and growth rate on GFR, while controlling for the impact of demographics, comorbidities, and tumor histology. RESULTS: The difference in average GFR decline between the 66 partial nephrectomy (PN) patients and the 67 AS patients was not significant (1.9 vs 0.5, p¼0.270). In contrast, there was a significantly greater decline in the 15 radical nephrectomy (RN) patients compared to the AS patients (9.2 vs 0.5, p¼0.001). Average follow up time for AS, PN, and RN patients was 20, 19, and 16 months, respectively. On regression analysis while controlling for comorbidities, GFR was again found to decline faster in RN (p¼0.016) but not PN (p¼0.778) patients compared to AS patients. Average growth rate of masses in the AS arm was 0.19 cm/year. There was no significant difference in GFR change between AS patients whose tumors increased in size over their enrollment and those whose tumors decreased in size, as shown in the table (p¼0.260). On regression analysis the tumor growth rate did not significantly affect the rate of GFR decline while controlling for comorbidities (p¼0.915). CONCLUSIONS: AS for the small renal mass yields equivalent preservation of GFR when compared to PN, while both modalities are superior to RN. Preservation of renal function during AS is unaffected by growth rate. These renal function outcomes should be considered when making treatment decisions.
e573
N
GFR Declined
No change in GFR
GFR Rose
Surveillance
67
31 (46%)
10 (15%)
26 (39%)
Partial Nephrectomy
66
38 (57%)
9 (13%)
20 (30%)
Radical Nephrectomy
15
13 (87%)
0 (0%)
2 (13%)
Within Surveillance: Tumor increased in size
42
7 (41%)
5 (29%)
5 (29%)
Tumor decreased in size
17
20 (48%)
5 (12%)
17 (40%)
Source of Funding: National Comprehensive Cancer Network (NCCN)
MP54-05 MENTAL HEALTH NOT AFFECTED BY ACTIVE SURVEILLANCE FOR PATIENTS WITH SMALL RENAL MASSES: QUALITY OF LIFE RESULTS FROM THE DISSRM (DELAYED INTERVENTION AND SURVEILLANCE FOR SMALL RENAL MASSES) REGISTRY Phillip Pierorazio, Michael Gorin*, Baltimore, MD; Matthew Danzig, Rashed Ghandour, New York, NY; Peter Chang, Robert Hartman, Andrew Wagner, Boston, MA; James McKiernan, New York, NY; Mohamad Allaf, Baltimore, MD INTRODUCTION AND OBJECTIVES: Quality-of-life (QOL) measures have not been evaluated in a rigorous fashion for patients undergoing active surveillance (AS) for small renal masses (SRM). The prospective, multi-institutional Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry was opened January 1, 2009, enrolling patients with SRM 4.0 cm who chose intervention or AS. METHODS: Patients were enrolled following consultation and choice of AS or intervention. Those electing AS followed an imaging protocol every 4-6 months for 2 years, then every 6-12 months for 3 years. SF12 QOL questionnaires were completed at enrollment, at 6 and 12 months, and annually thereafter. Mental Component Summary (MCS), Physical Component Summary (PCS) and overall score were evaluated among groups and over time with analysis of variance and linear regression modeling. RESULTS: At 57 months, among 4 institutions, 438 patients are enrolled: 177 elected AS, 261 primary intervention. 970 questionnaires have been completed at a mean of 12.5 months (0-48). QOL Scores are demonstrated in the Table. Among groups, intervention had significantly higher differences in total score at enrollment (p¼0.003) and 1-year (0.04). In PCS, intervention scores were higher at enrollment, 6 months and 1 and 2 years (p<0.045); there were no differences in MCS at any timepoint. A small increase in total score (coefficient 0.165, p¼0.04) and MCS (0.132, 0.005) were noted in the AS cohort over time; a very small increase in MCS was noted in the intervention cohort (0.067, 0.026). CONCLUSIONS: In a prospective registry of patients undergoing AS or immediate intervention for SRM, patients undergoing immediate intervention have higher QOL scores at baseline - specifically in domains that reflect their physical health. The perceived benefit in physical health persists for at least two years following intervention. Mental health, which includes domains of depression and anxiety, is not adversely affected while on AS. N Active Surveillance
SF12
MCS
PCS
Score
Range
Score
Range
Score
Range
50.8
11.4-66.5
40.7
20.1-62.2
Enrollment
89
92
47.9-114.7
6 months
60
95.9
62.7-116
56.1
34.2-65.5
40.9
12.9-57.9
1 year
43
94.7
59.7-114.7
55.1
22.6-64.8
42.0
21.7-57.2
2 year
31
95.4
66.5-114.7
55.2
24.1-26.9
42.2
22.5-57.9
3 year
20
98.9
66.1-116
57.45
34.7-68.4
41.1
16.5-57.5
4 year
13
99.7
75.7-114.6
59.5
41.5-63.3
42.4
23.7-55.3
Score
Range
Score
Range
Score
Range
Intervention Enrollment
225
100.7
47.9-117.4
52.5
22.8-69.7
50.7
20.3-64.8
6 months
151
105.4
50.7-117.4
55.5
13.5-69.3
50.2
18.6-63.5
1 year
137
106.1
51.5-117.4
55.9
17.5-66.4
51.2
21.4-64.2
2 year
101
104.5
54.8-117.4
56.7
20.8-66.9
49.0
20.8-61.7
3 year
69
99.4
55.8-117.4
56.0
24.2-63.8
44.2
18.7-58.9
4 year
31
97.8
47.1-117.4
52.9
17.6-61.2
50.7
5.38-59.3
Source of Funding: National Comprehensive Cancer Network (NCCN)