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MP43-10 THE ROLE OF SURVEILLANCE BIOPSY WITH NO CANCER AS A PROGNOSTIC MARKER FOR RECLASSIFICATION: RESULTS FROM THE CANARY PROSTATE ACTIVE SURVEILLANCE STUDY (PASS)
THE JOURNAL OF UROLOGYâ
Vol. 197, No. 4S, Supplement, Saturday, May 13, 2017
e557
largely respected. The percentage of therapy switches of this health services research study (42.5% in 66.7 months) is comparable to the results from clinical AS-trials. With an increase of the observation period, a higher proportion of patients changed to WW when AS was terminated, and remained on a non-invasive strategy. Source of Funding: The HAROW study was initiated and conducted by the Foundation of Men’s Health and financially supported by Gazprom Germania.
MP43-10 THE ROLE OF SURVEILLANCE BIOPSY WITH NO CANCER AS A PROGNOSTIC MARKER FOR RECLASSIFICATION: RESULTS FROM THE CANARY PROSTATE ACTIVE SURVEILLANCE STUDY (PASS)
Source of Funding: none
MP43-09 “ACTIVE SURVEILLANCE” IN THE EVERYDAY CARE: RESULTS FROM HAROW-A PROSPECTIVE, NONINTERVENTIONAL STUDY WITH A MEAN FOLLOW-UP OF 66.7 MONTHS. Jan Herden*, Cologne, Germany; Dietrich Schnell, Berlin, Germany; Axel Heidenreich, Cologne, Germany; Lothar Weissbach, Berlin, Germany INTRODUCTION AND OBJECTIVES: Active Surveillance (AS) is a treatment option for selected patients with localized prostate cancer (PCa) and low risk for progression. Most data on AS result from clinical trials, conducted at academic- or tertiary care centers. In contrast, in clinical practice AS is mostly applied by office based urologists. In this prospective, non-interventional, health services research study the use of five treatment options for localized PCa were compared under everyday conditions: Hormone therapy (HT), AS, Radiation therapy (RT), Operation (RP) and Watchful waiting (WW). Data of the ASsubgroup are presented in terms of inclusion criteria and changes in treatment strategy. METHODS: The study was conducted from July 2008 to July 2013 at 259 study centers in Germany, in 86% office based urologists. Clinical data (tumor category, digital rectal examination, PSA level, Gleason score, comorbidities) and information about therapy and disease progression were collected at the time of study inclusion and subsequently at six-month intervals. According to the non-interventional study design, only recommendations were made for enrollment, course and discontinuation of AS. The final therapeutic decision rested with treating physicians. RESULTS: Overall, 2957 patients were enrolled, of whom 468 (15.8%) received AS. The AS-group was characterized by the lowest mean baseline level of PSA (5.8 ng/mL), the highest proportion of patients with a Gleason score <7 (92.5%) and with low-risk tumors (82.5%). The mean follow up was 28.5 months. Up to this time 112 patients had changed treatment strategy (RP:65, RT:30, HT:10, WW:7). On the basis of a separate survey until July 2016, the mean follow up was extended to 66.7 months. By that time treatment strategy had changed in another 87 patients (RP:31, RT:18, HT:8, WW:30). In these two periods the rates of therapy switches per month were RP:2.3, RT:1.1, HT:0,4, WW:0,2 and RP:0.8, RT:0.5, HT:0.2, WW:0.8, respectively. Fifteen AS-patients died, but no tumor related deaths were seen. CONCLUSIONS: The results of HAROW indicate that AS is highly applicable in everyday care since the inclusion criteria were
James Kearns*, Anna Faino, Lisa Newcomb, Seattle, WA; James Brooks, Palo Alto, CA; Peter Carroll, San Francisco, CA; Atreya Dash, William Ellis, Seattle, WA; Michael Fabrizio, Norfolk, VA; Martin Gleave, Vancouver, Canada; Todd Morgan, Ann Arbor, MI; Peter Nelson, Seattle, WA; Ian Thompson, San Antonio, TX; Andrew Wagner, Boston, MA; Yingye Zheng, Daniel Lin, Seattle, WA INTRODUCTION AND OBJECTIVES: Many patients who are on active surveillance (AS) for prostate cancer (PCa) will have surveillance prostate needle biopsies (PNB) without any cancer evident. The prognostic meaning of these biopsies without cancer is unknown. We sought to define the association between negative surveillance PNB and risk of reclassification on AS. METHODS: All men were enrolled in the Canary Prostate Active Surveillance Study (PASS). Men were included if they had Gleason 3+4 PCa and ¼ 34% core involvement ratio at diagnosis and an on-study first surveillance PNB within 2 year of diagnosis. Reclassification was defined as an increase in primary or secondary Gleason grade and/or an increase in the ratio of biopsy cores with cancer to 34%. PNB outcomes were defined as: a) no evidence of cancer on biopsy, b) evidence of cancer on biopsy without reclassification, or c) reclassification. RESULTS: 657 men met inclusion criteria. On first surveillance PNB, 214 (33%) had no cancer, 282 (43%) had cancer but no reclassification, and 161 (25%) reclassified. Of the 496 men who did not reclassify, 313 had a 2nd PNB. On 2nd PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no reclassification, and 54 (17%) reclassified. In a multivariate analysis, significant predictors of future reclassification after 1st PNB were no cancer on PNB (HR ¼ 0.50, p ¼ 0.008), serum PSA, prostate size, and BMI (Table). Diagnostic Gleason score, maximum percentage of involved cores, race, T stage, and study site were considered and found to be non-significant. A finding of no cancer on the 2nd PNB was also associated with significantly decreased future reclassification on multivariate analysis (HR ¼ 0.15, p ¼ 0.003), regardless of first PNB result. CONCLUSIONS: Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These finding have implications for tailoring AS protocols.
Source of Funding: Canary Foundation, Department of Defense (PC130355), and Institute for Prostate Cancer Research
Vol. 197, No. 4S, Supplement, Saturday, May 13, 2017
e557
largely respected. The percentage of therapy switches of this health services research study (42.5% in 66.7 months) is comparable to the results from clinical AS-trials. With an increase of the observation period, a higher proportion of patients changed to WW when AS was terminated, and remained on a non-invasive strategy. Source of Funding: The HAROW study was initiated and conducted by the Foundation of Men’s Health and financially supported by Gazprom Germania.
MP43-10 THE ROLE OF SURVEILLANCE BIOPSY WITH NO CANCER AS A PROGNOSTIC MARKER FOR RECLASSIFICATION: RESULTS FROM THE CANARY PROSTATE ACTIVE SURVEILLANCE STUDY (PASS)
Source of Funding: none
MP43-09 “ACTIVE SURVEILLANCE” IN THE EVERYDAY CARE: RESULTS FROM HAROW-A PROSPECTIVE, NONINTERVENTIONAL STUDY WITH A MEAN FOLLOW-UP OF 66.7 MONTHS. Jan Herden*, Cologne, Germany; Dietrich Schnell, Berlin, Germany; Axel Heidenreich, Cologne, Germany; Lothar Weissbach, Berlin, Germany INTRODUCTION AND OBJECTIVES: Active Surveillance (AS) is a treatment option for selected patients with localized prostate cancer (PCa) and low risk for progression. Most data on AS result from clinical trials, conducted at academic- or tertiary care centers. In contrast, in clinical practice AS is mostly applied by office based urologists. In this prospective, non-interventional, health services research study the use of five treatment options for localized PCa were compared under everyday conditions: Hormone therapy (HT), AS, Radiation therapy (RT), Operation (RP) and Watchful waiting (WW). Data of the ASsubgroup are presented in terms of inclusion criteria and changes in treatment strategy. METHODS: The study was conducted from July 2008 to July 2013 at 259 study centers in Germany, in 86% office based urologists. Clinical data (tumor category, digital rectal examination, PSA level, Gleason score, comorbidities) and information about therapy and disease progression were collected at the time of study inclusion and subsequently at six-month intervals. According to the non-interventional study design, only recommendations were made for enrollment, course and discontinuation of AS. The final therapeutic decision rested with treating physicians. RESULTS: Overall, 2957 patients were enrolled, of whom 468 (15.8%) received AS. The AS-group was characterized by the lowest mean baseline level of PSA (5.8 ng/mL), the highest proportion of patients with a Gleason score <7 (92.5%) and with low-risk tumors (82.5%). The mean follow up was 28.5 months. Up to this time 112 patients had changed treatment strategy (RP:65, RT:30, HT:10, WW:7). On the basis of a separate survey until July 2016, the mean follow up was extended to 66.7 months. By that time treatment strategy had changed in another 87 patients (RP:31, RT:18, HT:8, WW:30). In these two periods the rates of therapy switches per month were RP:2.3, RT:1.1, HT:0,4, WW:0,2 and RP:0.8, RT:0.5, HT:0.2, WW:0.8, respectively. Fifteen AS-patients died, but no tumor related deaths were seen. CONCLUSIONS: The results of HAROW indicate that AS is highly applicable in everyday care since the inclusion criteria were
James Kearns*, Anna Faino, Lisa Newcomb, Seattle, WA; James Brooks, Palo Alto, CA; Peter Carroll, San Francisco, CA; Atreya Dash, William Ellis, Seattle, WA; Michael Fabrizio, Norfolk, VA; Martin Gleave, Vancouver, Canada; Todd Morgan, Ann Arbor, MI; Peter Nelson, Seattle, WA; Ian Thompson, San Antonio, TX; Andrew Wagner, Boston, MA; Yingye Zheng, Daniel Lin, Seattle, WA INTRODUCTION AND OBJECTIVES: Many patients who are on active surveillance (AS) for prostate cancer (PCa) will have surveillance prostate needle biopsies (PNB) without any cancer evident. The prognostic meaning of these biopsies without cancer is unknown. We sought to define the association between negative surveillance PNB and risk of reclassification on AS. METHODS: All men were enrolled in the Canary Prostate Active Surveillance Study (PASS). Men were included if they had Gleason 3+4 PCa and ¼ 34% core involvement ratio at diagnosis and an on-study first surveillance PNB within 2 year of diagnosis. Reclassification was defined as an increase in primary or secondary Gleason grade and/or an increase in the ratio of biopsy cores with cancer to 34%. PNB outcomes were defined as: a) no evidence of cancer on biopsy, b) evidence of cancer on biopsy without reclassification, or c) reclassification. RESULTS: 657 men met inclusion criteria. On first surveillance PNB, 214 (33%) had no cancer, 282 (43%) had cancer but no reclassification, and 161 (25%) reclassified. Of the 496 men who did not reclassify, 313 had a 2nd PNB. On 2nd PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no reclassification, and 54 (17%) reclassified. In a multivariate analysis, significant predictors of future reclassification after 1st PNB were no cancer on PNB (HR ¼ 0.50, p ¼ 0.008), serum PSA, prostate size, and BMI (Table). Diagnostic Gleason score, maximum percentage of involved cores, race, T stage, and study site were considered and found to be non-significant. A finding of no cancer on the 2nd PNB was also associated with significantly decreased future reclassification on multivariate analysis (HR ¼ 0.15, p ¼ 0.003), regardless of first PNB result. CONCLUSIONS: Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These finding have implications for tailoring AS protocols.
Source of Funding: Canary Foundation, Department of Defense (PC130355), and Institute for Prostate Cancer Research