ACTIVE SURVEILLANCE FOR RENAL MASSES: Where are we in 2016?

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1 ACTIVE SURVEILLANCE FOR RENAL MASSES: Where are we in 2016? Phillip M. Pierorazio, MD Assistant Professor of Urology and Oncology Brady Urological Institute Sidney Kimmel Cancer Center Johns Hopkins Hospital Baltimore, Maryland Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA

2 disclosures American Urological Association Kidney Cancer Guideline Committee National Comprehensive Cancer Network (NCCN) Young Investigator s Award: Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry Kidney Cancer Guidelines Committee Agency for Healthcare Research and Quality (AHRQ) Funded Investigator Management of Renal Masses and Localized Renal Cancer Myriad Genetics Kidney Cancer Advisory Board (unpaid) No relevant financial relationships to disclose. No non-fda approved use of drugs or products discussed in this presentation.

3 outline/objectives To review oncologic data from active surveillance (AS) programs. Practical considerations from an AS program. Imaging, growth rates and progression. To discuss the utility of renal mass biopsy in active surveillance. Quality of life

4 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA oncologic data ACTIVE SURVEILLANCE FOR RENAL MASSES

5 ACTIVE SURVEILLANCE LITERATURE Systematic Review Medline, Embase, Cochrane Reviews: 73 peer-reviewed articles 24 original series 2 prospective cohorts Patients: 1,795 ( per study) At median follow-up (21-92 months), median: Cancer-specific survival: 100% ( %) Metastasis-free survival: 98.9% (86.2%-100%) Overall survival: 88.8% (42.8%-100%) Johnson and Pierorazio. ACAM, in submission.

6 underutilization of active surveillance Yang et al. BJU International, Volume 110, Issue 8, pages , 28 FEB 2012 DOI: /j X x Smaldone et al. Urology, 2013.

7 active surveillance guideline statements AUA Guidelines [AS] is a reasonable option for patients with limited life expectancy or for those who are unfit for or do not desire surgery. Patients should be willing to assume an unknown, but low, oncologic risk associated with AS. EAU Guidelines that elderly and comorbid patients with incidentally discovered [SRM] are suitable for AS based on low cancer-specific mortality and significant competing-risk mortality. NCCN AS is suitable for select patients with T1a tumors.

8 PROSPECTIVE TRIALS OF ACTIVE SURVEILLANCE Renal Cell Consortium of Canada (RCCC) Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Region Canada United States Number of centers 8 3 Start of enrollment Year of last published results Eligibility criteria ct1an0m0 mass on imaging Deemed not fit for surgery 18 years or older, ct1an0m0 mass on imaging no personal history of RCC or a known familial RCC syndrome Study arms Active Surveillance only Active Surveillance, Primary and Delayed Intervention Renal Mass Biopsy (%) Recommended (55.6%) Tumors that are benign on biopsy are followed yearly. Offered (6.4%) Biopsy results do not change surveillance protocol. Surveillance protocol CT, MRI, or ultrasound at 3 and 6 months, then every 6 months until year 3, and then yearly. Ultrasound (recommended; or CT, or MRI) every 6 months for the first 2 years and every 1 year thereafter. Definition of local progression Tumor diameter of 4 cm or greater, or Doubling of tumor volume in 12 or fewer months Maximum diameter larger than 4.0 cm, Growth rate that exceeds 0.5 cm/year, Hematuria (or symptoms) suspected to be from the SRM Number of patients in last published results 178 (AS only) PI: 274 AS: 223 (of which 21 undergo DI) Follow-up period in last 28 (mean) 25 (median) published results (months) Tumor growth rate in last 0.13 (mean) 0.11 (median) published results (cm/year) Rate of local progression of 12% 16% AS arm in last published results (%) Rate of metastatic disease Active Surveillance: 1.1% AS arm: 0% PI arm: 0.7% DI arm: 0% in last published results (%) Survival outcomes Not reported 5-year OS for PI=92%; AS=75% 5-year CSS for PI=99%; AS=100%

9 Opened: January 1, 2009 Prospective Registry Solid, ct1a (4cm) tumors Multi-institutional: Johns Hopkins Columbia Univ. (McKiernan) Beth Israel Deaconess (Wagner) Primary Objective: Non-inferiority of AS based on historical 5 year CSS rates (95%).

10 DISSRM: vital statistics, October 1, patients 3.01 years [IQR: ] median follow-up Primary Intervention: n=255 Active Surveillance: n=288 Crossover: n=45 Surveillance patients are: Older: 70.8 v (P<0.001) Worse Health: ECOG 2-4: 5.8% v. 2.5% (P=0.045) Charlson 0: 43.5% v. 60.1% (P<0.001) Smaller tumors: 1.8 [ ] vs. 2.5 [ ] (P<0.001) More complex tumors: 40.9% vs. 32.8% (P=0.1) intermediate- to high-renal score

11

12

13 Progression: Growth Rate >0.5cm/year (n=64) Tumor > 4cm (n=6) Metastatic Disease (n=0) Crossover (n=45)

14 active surveillance oncologic outcomes Active surveillance remains underutilized. Intermediate-term, oncologic outcomes indicate active surveillance is non-inferior to primary intervention. Cancer-specific survival is excellent. Metastases-free survival is excellent.

15 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA practical considerations ACTIVE SURVEILLANCE FOR RENAL MASSES

16

17 imaging modality in DISSRM 197 (62.5%) 84 (26.7%) 34 (10.8%) 387 (42.3%) 197 (24.5%) 331 (36.2%) Surveillance protocol: Renal mass imaging every 6 months for 2 years, annually thereafter. Axial imaging required within 6 months. Annual chest imaging, complete metabolic panel. Ultrasound is the preferred surveillance modality. Active surveillance can/should be highly individualized. Variable time intervals are reasonable based on patient/tumor risk stratification. Alternating axial imaging for surgical candidates.

18 Tumor Size (cm) growth rates in active surveillance Overall Growth Rate (n=251) Median: 0.09 cm/year (IQR, to 0.31) Time (Years)

19 Grwoth Rate (cm/year) growth rates in active surveillance Waterfall Plot of Overall Tumor Growth Rates 30.8% <0 cm/year in % 0 cm/year in % cm/year 20.8% >0.5 cm/year in 33

20 growth rates in active surveillance Growth of SRMs in AS Patients Time Mean GR (cm/year) SD 6 months 0.22 ± months 0.12 ± months 0.13 ± months 0.09 ±0.25 Growth Time (Years) Variability in growth rate is high within the first year of imaging and decreases with longer follow-up. Avoid intervention. Consider renal mass biopsy.

21 Tumor Size (cm) growth rates in active surveillance Overall Growth Rate (n=251) Median: 0.09 cm/year (IQR, to 0.31) Most growing tumors demonstrate non-linear growth Time (Years)

22 positive growth periods by pathology Benign, chromophobe & low grade, pt1-2 High grade or pt3 (and above) Favorable 86 (69.4%) Unfavorable 38 (30.6%) # % # % % % % % % % % 3 7.9% 4 0 0% 2 5.3% Number of positive growth periods was positively correlated with unfavorable pathology. Overall growth rate (mean[sd] cm/year) 0.7[1.7] vs 1.6[2.8], p=0.07 Cochran-Armitage trend test (p=0.02) Somers D (0.15, 95%CI[0.02, 0.29])

23 rethinking progression 30% of patients progress by 7 years. Growth rate >0.5cm/year (n=64) Delayed intervention (n=45) Most (75%) are elective crossovers Tumor size >4cm (n=6) Metastatic disease (n=0) no deaths Oncologic outcomes are driven by tumor stage, size. Growth rate is a poor predictor of malignant potential. Grade and stage reclassification? Persistent growth?

24 practical considerations Surveillance can/should be highly individualized. Ultrasound is preferred imaging modality. Most SRM will grow slowly (or not at all). Traditional thoughts about progression while on active surveillance are challenged by contemporary data. Growth rate within the first year (especially 6 months) is a highly variable. Unreliable predictor of overall growth rate. Tumor size and stage drive cancer-specific survival. Growth rate is a likely adjunct to tumor size. Persistent growth versus linear growth rate

25 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA role of renal mass biopsy ACTIVE SURVEILLANCE FOR RENAL MASSES

26 systematic review: percutaneous renal biopsy 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Performance Characteristics 97.5% 96.2% 99.8% Sensitvity Specificity Positive Predictive Value 68.5% Negative Predictive Value 14% Non-Diagnostic Rate Lower limit of Negative Predictive Value as all patients in this series underwent extirpation. Moderate level of evidence. Histology: 90% concordance Grade (14 studies, 688 tumors) 87.8% low-grade tumors 16.0% upgraded 50% for high-grade tumors

27 Only 40% of high-grade tumors are grade 3-4. Tumor Heterogeneity

28 renal mass biopsy in DISSRM Year Active Surveillance Intervention Crossover / 543 (16.8%) 45 / 288 (15.6%) 34 / 255 (13.3%) 12 / 45 (26.7%) 5%

29 renal mass biopsy in AS Renal mass biopsy is not a requisite for safe active surveillance. A well-informed consultation regarding the risk-stratification of a given patient s renal mass can help decide if/when RMB is useful. Specific roles for RMB: Young women with masses <2cm who desire surgery Growing mass on AS SRM considering radical nephrectomy Patients who want more information Gray zone patients

30 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA quality of life ACTIVE SURVEILLANCE FOR RENAL MASSES

31 Quality of Life favors primary intervention patients Driven by perceived differences in physical health, not mental health domains Patel, et al

32 Mental (emotional) quality of life improves for all patients Patel, et al Patel, et al. JUROL, 2016.

33 active surveillance for renal masses where are we in 2016? Prospective data supports active surveillance as a safe, non-inferior management strategy for patients with ct1a (<4cm) tumors. Imaging intervals/modalities should be individualized. Ultrasound is the preferred AS modality. Alternating axial imaging for surgical candidates. Short-term growth rates are unreliable predictors of malignant potential. Overall tumor size is our best predictor of outcome. Intervention should not be based on GR in 1 st year. Consistent growth may indicate malignant potential. Renal mass biopsy has a role, but is not essential for AS. Quality of life is preserved (perhaps improved) in a structured AS program.

34 Mohamad Allaf, MD Michael Gorin, MD Michael Johnson, MD Mark Riffon, MPH Heather Gausepohl, NP Tina Driscoll Hiten Patel, MD Alice Semerjian, MD Alex Jang Ridwan Alam JHH kidney cancer team

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