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How Active is Active Surveillance? Intensity of Follow-Up During Active Surveillance for Prostate Cancer in the United States
Loeb, Stacy; Walter, Dawn; Curnyn, Caitlin; Gold, Heather T; Lepor, Herbert; Makarov, Danil V
PURPOSE: While major prostate cancer active surveillance (AS) programs recommend repeat testing such as PSA and prostate biopsy, compliance with such testing is unknown. Our objective was to determine whether men in the community receive the same intensity of AS testing as in prospective AS protocols. MATERIALS AND METHODS: We performed a retrospective cohort study of men aged >/=66 in the SEER-Medicare database diagnosed with prostate cancer from 2001-2009 who did not receive curative therapy in the year after diagnosis with >/=1 post-diagnosis prostate biopsy. We used multivariable-adjusted Poisson regression to determine the association between frequency of AS testing with patient demographics and clinical features. Among 1349 men with =5 years follow-up, we determined the proportion undergoing testing of the intensity recommended by the Sunnybrook and PRIAS programs (>/=14 PSA and >/=2 biopsy), and at Johns Hopkins (>/=10 PSA and >/=4 biopsy). RESULTS: Among 5192 patients undergoing AS, >80% had >/=1 PSA test per year but <13% received biopsy beyond the first 2 years. MRI was rarely used during the study period. On multivariable analysis, recent diagnosis and higher income were associated with higher frequency of surveillance biopsy, while older age and greater comorbidity were associated with fewer biopsies. African American men underwent fewer PSAs but similar numbers of biopsies. During 5 years of AS, only 11.1% and 5.0% met the testing standards of the Sunnybrook/PRIAS and Johns Hopkins programs. CONCLUSIONS: In the community, very few elderly men receive the intensity of AS testing recommended by major prospective AS programs.; Key of Definition for Abbreviations: AS=active surveillance, PCa=prostate cancer, PSA=prostate specific antigen, MRI=magnetic resonance imaging, NCCN=National Comprehensive Cancer Network, PRIAS=Prostate Cancer Research International Active Surveillance, WW=watchful waiting.
PMCID:5010531
PMID: 26946161
ISSN: 1527-3792
CID: 2046422
UNDERSTANDING THE LIMITATIONS OF PROSTATE-SPECIFIC ANTIGEN TESTING DOES NOT DETER MEN FROM UNDERGOING PROSTATE CANCER SCREENING [Meeting Abstract]
Fenstermaker, Michael; Loeb, Stacy; Gold, Heather T; Ravenell, Joseph; Makarov, Danil
ISI:000362552200116
ISSN: 1527-3792
CID: 2225652
Health Policy for Prostate Cancer: PSA Screening as Case Study
Chapter by: Venkatachalam, S; Makarov, DV
in: Prostate Cancer: Science and Clinical Practice by
pp. 605-612
ISBN: 9780128000779
CID: 2169132
Regional variations in US cancer imaging data: a warning for imaging overuse
Makarov, Danil V
Danil V Makarov speaks to Gemma Westcott, Commissioning Editor: Danil V Makarov is an Assistant Professor and Director of Surgical Research in the Department of Urology at NYU Langone Medical Center (NY, USA). In addition, he is an Assistant Professor in the Department of Population Health. His clinical areas of expertise include prostate cancer, benign prostatic hyperplasia, erectile dysfunction, kidney cancer, urinary tract infections, genitourinary neoplasm, elevated prostate-specific antigen and testicular cancer. In addition, his research interests are in the areas of prostate cancer, health policy and quality of care. An alumnus of the Johns Hopkins University School of Medicine (MD, USA), he completed his residency in urology at Johns Hopkins Hospital and a research fellowship at Yale University School of Medicine (CT, USA).
PMID: 26436665
ISSN: 1744-8301
CID: 1794502
Regional-Level Correlations in Inappropriate Imaging Rates for Prostate and Breast Cancers: Potential Implications for the Choosing Wisely Campaign
Makarov, Danil V; Soulos, Pamela R; Gold, Heather T; Yu, James B; Sen, Sounok; Ross, Joseph S; Gross, Cary P
IMPORTANCE: The association between regional norms of clinical practice and appropriateness of care is incompletely understood. Understanding regional patterns of care across diseases might optimize implementation of programs like Choosing Wisely, an ongoing campaign to decrease wasteful medical expenditures. OBJECTIVE: To determine whether regional rates of inappropriate prostate and breast cancer imaging were associated. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study using the the Surveillance, Epidemiology, and End Results-Medicare linked database. We identified patients diagnosed from 2004 to 2007 with low-risk prostate (clinical stage T1c/T2a; Gleason score, =6; and prostate-specific antigen level, <10 ng/mL) or breast cancer (in situ, stage I, or stage II disease), based on Choosing Wisely definitions. MAIN OUTCOMES AND MEASURES: In a hospital referral region (HRR)-level analysis, our dependent variable was HRR-level imaging rate among patients with low-risk prostate cancer. Our independent variable was HRR-level imaging rate among patients with low-risk breast cancer. In a subsequent patient-level analysis we used multivariable logistic regression to model prostate cancer imaging as a function of regional breast cancer imaging and vice versa. RESULTS: We identified 9219 men with prostate cancer and 30398 women with breast cancer residing in 84 HRRs. We found high rates of inappropriate imaging for both prostate cancer (44.4%) and breast cancer (41.8%). In the first, second, third, and fourth quartiles of breast cancer imaging, inappropriate prostate cancer imaging was 34.2%, 44.6%, 41.1%, and 56.4%, respectively. In the first, second, third, and fourth quartiles of prostate cancer imaging, inappropriate breast cancer imaging was 38.1%, 38.4%, 43.8%, and 45.7%, respectively. At the HRR level, inappropriate prostate cancer imaging rates were associated with inappropriate breast cancer imaging rates (rho = 0.35; P < .01). At the patient level, a man with low-risk prostate cancer had odds ratios (95% CIs) of 1.72 (1.12-2.65), 1.19 (0.78-1.81), or 1.76 (1.15-2.70) for undergoing inappropriate prostate imaging if he lived in an HRR in the fourth, third, or second quartiles, respectively, of inappropriate breast cancer imaging, compared with the lowest quartile. CONCLUSIONS AND RELEVANCE: At a regional level, there is an association between inappropriate prostate and breast cancer imaging rates. This finding suggests the existence of a regional-level propensity for inappropriate imaging utilization, which may be considered by policymakers seeking to improve quality of care and reduce health care spending in high-utilization areas.
PMCID:4707944
PMID: 26181021
ISSN: 2374-2445
CID: 1668982
Undertreatment of Men in Their Seventies with High-risk Nonmetastatic Prostate Cancer
Bratt, Ola; Folkvaljon, Yasin; Hjalm Eriksson, Marie; Akre, Olof; Carlsson, Stefan; Drevin, Linda; Franck Lissbrant, Ingela; Makarov, Danil; Loeb, Stacy; Stattin, Par
BACKGROUND: Many elderly men with high-risk nonmetastatic prostate cancer (HRnMPCa) do not receive radical treatment, despite the high mortality associated with conservative management. OBJECTIVE: To investigate how age and comorbidity affect treatment of men with HRnMPCa. DESIGN, SETTING, AND PARTICIPANTS: This was an observational nationwide register study during 2001-2012. We identified 19 190 men of <80 yr of age diagnosed with HRnMPCa in the National Prostate Cancer Register of Sweden and 95 948 age-matched men without prostate cancer in the register of the total population. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcome was the proportion of men with HRnMPCa receiving radical treatment (radical prostatectomy or radiotherapy). Vital status and the Charlson comorbidity index (CCI) were obtained from nationwide registers. The 10-yr survival of men without prostate cancer, stratified by age and CCI, was used as a measure of the life expectancy of the men with prostate cancer. RESULTS AND LIMITATIONS: The proportions receiving radical treatment varied with life expectancy among men younger than 70 yr, whereas use of these treatments did not match the long life expectancy of men in their seventies with CCI 0-1. Only 10% of men aged 75-80 yr with CCI 0 received radical treatment despite 52% probability of 10-yr life expectancy, compared with approximately half of the men younger than 70 yr with a similar life expectancy. The use of radical treatment for HRnMPCa increased with time in all Swedish counties, but a threefold difference between counties remained in 2009-2012 for patients aged 70-80 yr with CCI 0-1. Uncertain external validity is a study limitation, and the impact of physician versus patient preferences on treatment selection could not be assessed. CONCLUSIONS: Otherwise healthy men in their seventies with HRnMPCa were less likely to receive radical treatment than younger men with a similar life expectancy, although increasing use of radical treatment was observed during the study period. Our findings highlight the need for improved methods for clinical decision-making, including improved assessment of life expectancy. PATIENT SUMMARY: We performed a nationwide register study that showed that many healthy men in their seventies live for at least another 10 yr. Despite this long life expectancy, men in their seventies with high-risk nonmetastatic prostate cancer were often not treated with radical prostatectomy or radiotherapy, possibly because their life expectancy was underestimated. Our study highlights the need for improved clinical decision-making, which should incorporate an assessment of the patient's life expectancy.
PMID: 25813688
ISSN: 1873-7560
CID: 1640152
Under-treatment of men in their seventies with high risk, non-metastatic prostate cancer [Meeting Abstract]
Stattin, P; Folkvaljon, Y; Hjalm, Eriksson M; Akre, O; Carlsson, S; Drevin, L; Franck, Lissbrant I; Makarov, D; Loeb, S; Bratt, O
INTRODUCTION & OBJECTIVES: Many elderly men do not receive curative treatment for high risk, non-metastatic prostate cancer (HRnMPCa) despite high mortality with conservative management. We aimed to assess how age and comorbidity affect treatment of men with HRnMPCa. MATERIAL & METHODS: The proportion of men with HRnMPCa treated curatively in Sweden in 2001 to 2012 was assessed in this nationwide, population-based study. 19,190 men with HRnMPCa below age 80 at date of diagnosis were identified in the National Prostate Cancer Register (NPCR) and 95,948 age-matched control men were without prostate cancer retrieved from the Register of the Total Population. 10-year survival in control men, stratified by age and Charlson Comorbidity Index (CCI) was used as a measure of the life expectancy of the men with prostate cancer. RESULTS: The proportion receiving curative treatment co-varied with life expectancy in men below age 70, but not in men in their seventies with CCI 0-1. For example, only 10% of men aged 75-80 years with CCI 0 received curative treatment despite a 52% 10-year survival probability, whereas half of men younger than 70 years with similar life expectancy received curative treatment. The use of curative treatment for HRnMPCa increased during the study period in all counties, but a threefold difference between counties for men aged 70-80 years with CCI 0-1 remained in 2009-2012. CONCLUSIONS: Otherwise healthy men in their seventies with HRnMPCa were less likely to receive treatment than younger men with a similar life expectancy. The disparities in use of curative treatment highlight the need for improved assessment of life expectancy
EMBASE:71831886
ISSN: 1569-9056
CID: 1561152
Institutional characteristics associated with receipt of emergency care for obstructive pyelonephritis at community hospitals
Borofsky, Michael S; Walter, Dawn; Li, Huilin; Shah, Ojas; Goldfarb, David S; Sosa, R Ernest; Makarov, Danil V
PURPOSE: Delivering the recommended care is an important quality measure that has been insufficiently studied in urology. Obstructive pyelonephritis is a suitable case study for this focus because many patients do not receive such care, although guidelines advocate decompression. We determined the influence of hospital factors, particularly familiarity with urolithiasis, on the likelihood of decompression in such patients. MATERIALS AND METHODS: We used the NIS from 2002 to 2011 to retrospectively identify patients admitted to community hospitals with severe infection and ureteral calculi. Hospital familiarity with nephrolithiasis was estimated by calculating hospital stone volume (divided into quartiles) and hospital treatment intensity (the decompression rate in patients with ureteral calculi and no infection). After calculating national estimates we performed logistic regression to determine the association between the receipt of decompression and hospital stone volume, controlling for treatment intensity and other covariates thought to be associated with receiving recommended care. RESULTS: Of an estimated 107,848 patients with obstructive pyelonephritis 27.4% failed to undergo decompression. Discrepancies were greatest between hospitals with the highest and lowest stone volumes (76% vs 25%, OR 2.77, 95% CI 1.94-3.96, p <0.01) as well as high and low treatment intensity (78% vs 37%, p <0.01). CONCLUSIONS: High hospital stone volume and treatment intensity were associated with an increased likelihood of receiving decompression. Such findings might be useful to identify hospitals and regions where access to quality urological care should be augmented.
PMID: 25234299
ISSN: 0022-5347
CID: 1506662
Five-year Nationwide Follow-up Study of Active Surveillance for Prostate Cancer
Loeb, Stacy; Folkvaljon, Yasin; Makarov, Danil V; Bratt, Ola; Bill-Axelson, Anna; Stattin, Par
BACKGROUND: Active surveillance (AS) is an important yet underutilized strategy to reduce prostate cancer (PCa) overtreatment. OBJECTIVE: To examine the 5-yr outcomes of AS in a population-based setting. DESIGN, SETTING, AND PARTICIPANTS: From the National Prostate Cancer Register of Sweden, we identified 11 726 men =70 yr diagnosed with very low-risk to intermediate-risk PCa from 2003 to 2007 who completed 5 yr of follow-up. Of these men, 1729 (15%) chose AS for the primary management strategy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We calculated the probability of discontinuation of AS over time, and Cox proportional hazards models were used to determine factors associated with discontinuation. Reasons for discontinuation were assessed by data extraction from medical charts. RESULTS AND LIMITATIONS: By 5 yr, 64% of the men remained on AS. Predictors of discontinuation were younger age, fewer comorbidities, more education, higher prostate-specific antigen (PSA), and clinical stage T2 disease; marital status did not predict discontinuation. In a subset with data on the reason for discontinuation (86%), 20% of men discontinued because of patient preference, 52% because of PSA progression, 24% because of biopsy progression, and 3% for other reasons. CONCLUSIONS: In a population-based setting, the majority of men remained on AS at 5 yr. However, one-fifth of the men who discontinued AS did so for nonbiologic reasons. Thus, there is a need for support and counseling for men to continue AS in the absence of signs of progression to improve adherence to AS and decrease overtreatment. PATIENT SUMMARY: Active surveillance (AS) is an important option to delay or avoid treatment for men with favorable prostate cancer features. This study shows that at 5 yr, 64% of men across an entire population remained on AS. We concluded that AS is a durable option and that counseling may be useful to promote adherence for men without progression.
PMCID:4280355
PMID: 24993868
ISSN: 0302-2838
CID: 1495292
Guideline of Guidelines: Prostate Cancer Imaging
Wollin, Daniel A; Makarov, Danil V
In the era before the widespread adoption of PSA screening for prostate cancer, most incident cases were already advanced stage. Because treatment options such as surgery or radiation are thought mainly to benefit patients with localized disease, prostate cancer imaging was necessary prior to treatment of almost all patients. In the PSA era, however, over 90% of incident cases are localized, making the need for routine imaging with CT, MRI, or bone scan obsolete [1]. Numerous studies show a relatively low rate of positive staging imaging in low- and intermediate- risk patients. Recognizing these trends, several professional societies issued prostate cancer imaging guidelines in the mid-1990s in an effort to curb the overuse of imaging
PMCID:4768736
PMID: 25715887
ISSN: 1464-4096
CID: 1473942