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2032 OUTCOMES OF ACTIVE SURVEILLANCE FOR EARLY STAGE PROSTATE CANCER
Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010
2032 OUTCOMES OF ACTIVE SURVEILLANCE FOR EARLY STAGE PROSTATE CANCER Jared Whitson*, Sima Porten, Janet Cowan, Peter Carroll, San Francisco, CA INTRODUCTION AND OBJECTIVES: Given concern about prostate cancer over diagnosis due to the use of PSA-based screening practices, there has been a renewed interest in active surveillance in lieu of immediate treatment. However, the safety and efficacy of such an approach requires validation. We describe the results of an ongoing, prospective study of such an approach. METHODS: This is a prospective cohort study at a single academic institution of men with prostate cancer who chose active surveillance as their initial management strategy. Men were excluded if they had not yet reached 6 months follow-up after diagnostic biopsy. Data from the entire cohort are presented and additionally from just those men who underwent radical prostatectomy. The primary outcome in this subset was biochemical recurrence free survival which was defined as PSA ⬍ 0.2ng/ml and no second treatment. RESULTS: Four hundred seventy-seven subjects form the cohort. The median age at diagnosis was 62 years (range 40-86 years). As expected this was a very low risk cohort at diagnosis – 86% had a PSA ⬍ 10, 64% were clinical T1c, and the Gleason grade was ⱕ6 in 93%. Overall, 74% were low risk by d’Amico classification. 296 subjects had at least one repeat biopsy of which 125 (42%) experienced an upgrade. Of the entire study group, 324 (68%) are still being managed with active surveillance. Treatment-free survival was strongly associated with an upgrade on biopsy – 72% at five years without an upgrade versus 44% at five years with an upgrade. Of those men undergoing treatment, 75 out of 153 (49%) have undergone radical prostatectomy. The Gleason grade was ⱕ6 in 33%. 68% had ⱕT2 disease. However, 25% of subjects had extracapsular extension and 7% had seminal vesicle invasion. Surgical margins were negative in 85%. The three year biochemical recurrence free survival is 100% to date. CONCLUSIONS: The majority of men on active surveillance will be free of treatment at five years. Grade progression is relatively common. Of those who undergo radical prostatectomy, a minority will have adverse pathology. However, early biochemical recurrence free survival appears excellent. Source of Funding: None
2033 RESULT OF SECOND BIOPSY IS IMPORTANT FOR DECISION MAKING BEFORE ENTERING ACTIVE SURVEILLANCE PROTOCOL FOR LOW RISK PROSTATE CANCER Ari Adamy*, David S. Yee, Kazuhito Matsushita, Angel M. Cronin, Alexandra C. Maschino, Bertrand Guillonneau, Peter T. Scardino, James Eastham, New York, NY INTRODUCTION AND OBJECTIVES: For patients with low risk prostate cancer, active surveillance (AS) with deferred definitive therapy seems to be a safe alternative to radical treatment. The aim of this study was to evaluate the predictors of still meeting the initial eligibility criteria during follow-up after entering an AS protocol. METHODS: We identified patients diagnosed with prostate cancer who met a previously defined criteria (PSA ⱕ 10 ng/ml, Gleason ⱕ 6, cT2a or less, ⱕ 3 or less positive cores and no more than 50% of a core involved with tumor) and elected to undergo AS between March 1993 and April 2009. The analyses included 240 patients who were confirmed to meet these criteria with a subsequent biopsy. Kaplan-Meier methods were used to estimate the probability of remaining eligible for AS based on the initial criteria over time. Univariate and multivariable Cox proportional hazards regression were used to evaluate predictors of failure to meet the original criteria after entering AS protocol. RESULTS: Of the 240 patients included in the analysis, 179 still met the eligibility criteria during follow-up. Of the 61 patients who failed,
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most did it because of rising PSA (n⫽33, 54%) or Gleason grade (n⫽23, 38%). Of note, the majority of patients (n⫽19) who failed only due to PSA higher than 10 still had favorable prostate biopsies and remained on AS at last followup. The median follow-up for those who still met the inclusion criteria was 1.8 years. The 2 and 5-year probabilities of remaining eligible for AS were 79% (95% CI 72%-84%) and 61% (95% CI 51%-70%), respectively. On multivariable analysis, PSA at second biopsy (HR 1.28; 95%CI 1.13, 1.45; p⬍0.0005) and negative second biopsy (HR 0.56; 95%CI 0.32, 0.99; p⫽0.046) were independent predictors of failure to meet the inclusion criteria during follow-up. At five years the probability of remaining eligible for AS was 71% (95%CI 57%, 79%) for patients with a negative second biopsy and 45% (95%CI 28%, 61%) for those with a positive second biopsy. (Figure) CONCLUSIONS: Among patients placed on active surveillance, those with no cancer detected in the second biopsy are more likely to continue to meet the initial eligibility criteria during follow-up. Patients considering active surveillance should undergo a second biopsy to better access the risk of changes in AS eligibility.
Source of Funding: None
2034 HISTOPATHOLOGIC AND FUNCTIONAL OUTCOMES FOR ACTIVE SURVEILLANCE CANDIDATES WHO OPT FOR PROSTATECTOMY Jonathan Brajtbord*, Hugh Lavery, Fatima Nabizada-Pace, Prathibha Senaratne, David Samadi, New York, NY INTRODUCTION AND OBJECTIVES: Active surveillance (AS) is growing in popularity as a treatment option for men with low-risk localized prostate cancer. We evaluated the final histopathologic and functional outcomes of patients with preoperatively low-risk cancer and those who qualified for AS, but opted for robotic-assisted laparoscopic prostatectomy (RALP). METHODS: An institutional database was reviewed for 1,161 RALP performed by a single surgeon (DBS). Patients with ⬙low preoperative risk disease⬙ were defined as PSA ⬍ 10 ng/mL, clinical stage ⱕT2a and biopsy Gleason score ⱕ6 (n⫽596). Patients who qualified for active surveillance were identified as fulfilling the criteria for ⬙low-risk disease⬙ but additionally had ⬍3 positive cores and ⬍50% tumor volume in a single core (n⫽327). Continence was defined as ⱕ1 security pad daily. Potency was defined as a SHIM ⱖ16 in patients who were preoperatively potent. Biochemical recurrence (BCR) was defined as PSA ⬎ 0.2 ng/ml. RESULTS: On final histopathology, 284 (48%) of the 596 low-risk patients were upgraded from a Gleason 6 biopsy score to 3⫹4 ⫽ 7 and 46 (9.1%) patients were upgraded to 4⫹3 ⫽ 7. Two patients were upgraded to Gleason 8/9. 32 (5.4%) patients were upstaged to pT3/4. In the group of AS patients, 130 (40%) of the 327 patients were upgraded to Gleason 3⫹4⫽ 7 and 11 (3.3%) patients were upgraded to 4⫹3⫽7, but none to Gleason 8 or higher.11 (3.3%) patients were upstaged to T3/4 disease, 3 of whom were also upgraded. Bilateral nerve sparing was performed on 97% of patients in the AS cohort. At 12
2032 OUTCOMES OF ACTIVE SURVEILLANCE FOR EARLY STAGE PROSTATE CANCER Jared Whitson*, Sima Porten, Janet Cowan, Peter Carroll, San Francisco, CA INTRODUCTION AND OBJECTIVES: Given concern about prostate cancer over diagnosis due to the use of PSA-based screening practices, there has been a renewed interest in active surveillance in lieu of immediate treatment. However, the safety and efficacy of such an approach requires validation. We describe the results of an ongoing, prospective study of such an approach. METHODS: This is a prospective cohort study at a single academic institution of men with prostate cancer who chose active surveillance as their initial management strategy. Men were excluded if they had not yet reached 6 months follow-up after diagnostic biopsy. Data from the entire cohort are presented and additionally from just those men who underwent radical prostatectomy. The primary outcome in this subset was biochemical recurrence free survival which was defined as PSA ⬍ 0.2ng/ml and no second treatment. RESULTS: Four hundred seventy-seven subjects form the cohort. The median age at diagnosis was 62 years (range 40-86 years). As expected this was a very low risk cohort at diagnosis – 86% had a PSA ⬍ 10, 64% were clinical T1c, and the Gleason grade was ⱕ6 in 93%. Overall, 74% were low risk by d’Amico classification. 296 subjects had at least one repeat biopsy of which 125 (42%) experienced an upgrade. Of the entire study group, 324 (68%) are still being managed with active surveillance. Treatment-free survival was strongly associated with an upgrade on biopsy – 72% at five years without an upgrade versus 44% at five years with an upgrade. Of those men undergoing treatment, 75 out of 153 (49%) have undergone radical prostatectomy. The Gleason grade was ⱕ6 in 33%. 68% had ⱕT2 disease. However, 25% of subjects had extracapsular extension and 7% had seminal vesicle invasion. Surgical margins were negative in 85%. The three year biochemical recurrence free survival is 100% to date. CONCLUSIONS: The majority of men on active surveillance will be free of treatment at five years. Grade progression is relatively common. Of those who undergo radical prostatectomy, a minority will have adverse pathology. However, early biochemical recurrence free survival appears excellent. Source of Funding: None
2033 RESULT OF SECOND BIOPSY IS IMPORTANT FOR DECISION MAKING BEFORE ENTERING ACTIVE SURVEILLANCE PROTOCOL FOR LOW RISK PROSTATE CANCER Ari Adamy*, David S. Yee, Kazuhito Matsushita, Angel M. Cronin, Alexandra C. Maschino, Bertrand Guillonneau, Peter T. Scardino, James Eastham, New York, NY INTRODUCTION AND OBJECTIVES: For patients with low risk prostate cancer, active surveillance (AS) with deferred definitive therapy seems to be a safe alternative to radical treatment. The aim of this study was to evaluate the predictors of still meeting the initial eligibility criteria during follow-up after entering an AS protocol. METHODS: We identified patients diagnosed with prostate cancer who met a previously defined criteria (PSA ⱕ 10 ng/ml, Gleason ⱕ 6, cT2a or less, ⱕ 3 or less positive cores and no more than 50% of a core involved with tumor) and elected to undergo AS between March 1993 and April 2009. The analyses included 240 patients who were confirmed to meet these criteria with a subsequent biopsy. Kaplan-Meier methods were used to estimate the probability of remaining eligible for AS based on the initial criteria over time. Univariate and multivariable Cox proportional hazards regression were used to evaluate predictors of failure to meet the original criteria after entering AS protocol. RESULTS: Of the 240 patients included in the analysis, 179 still met the eligibility criteria during follow-up. Of the 61 patients who failed,
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most did it because of rising PSA (n⫽33, 54%) or Gleason grade (n⫽23, 38%). Of note, the majority of patients (n⫽19) who failed only due to PSA higher than 10 still had favorable prostate biopsies and remained on AS at last followup. The median follow-up for those who still met the inclusion criteria was 1.8 years. The 2 and 5-year probabilities of remaining eligible for AS were 79% (95% CI 72%-84%) and 61% (95% CI 51%-70%), respectively. On multivariable analysis, PSA at second biopsy (HR 1.28; 95%CI 1.13, 1.45; p⬍0.0005) and negative second biopsy (HR 0.56; 95%CI 0.32, 0.99; p⫽0.046) were independent predictors of failure to meet the inclusion criteria during follow-up. At five years the probability of remaining eligible for AS was 71% (95%CI 57%, 79%) for patients with a negative second biopsy and 45% (95%CI 28%, 61%) for those with a positive second biopsy. (Figure) CONCLUSIONS: Among patients placed on active surveillance, those with no cancer detected in the second biopsy are more likely to continue to meet the initial eligibility criteria during follow-up. Patients considering active surveillance should undergo a second biopsy to better access the risk of changes in AS eligibility.
Source of Funding: None
2034 HISTOPATHOLOGIC AND FUNCTIONAL OUTCOMES FOR ACTIVE SURVEILLANCE CANDIDATES WHO OPT FOR PROSTATECTOMY Jonathan Brajtbord*, Hugh Lavery, Fatima Nabizada-Pace, Prathibha Senaratne, David Samadi, New York, NY INTRODUCTION AND OBJECTIVES: Active surveillance (AS) is growing in popularity as a treatment option for men with low-risk localized prostate cancer. We evaluated the final histopathologic and functional outcomes of patients with preoperatively low-risk cancer and those who qualified for AS, but opted for robotic-assisted laparoscopic prostatectomy (RALP). METHODS: An institutional database was reviewed for 1,161 RALP performed by a single surgeon (DBS). Patients with ⬙low preoperative risk disease⬙ were defined as PSA ⬍ 10 ng/mL, clinical stage ⱕT2a and biopsy Gleason score ⱕ6 (n⫽596). Patients who qualified for active surveillance were identified as fulfilling the criteria for ⬙low-risk disease⬙ but additionally had ⬍3 positive cores and ⬍50% tumor volume in a single core (n⫽327). Continence was defined as ⱕ1 security pad daily. Potency was defined as a SHIM ⱖ16 in patients who were preoperatively potent. Biochemical recurrence (BCR) was defined as PSA ⬎ 0.2 ng/ml. RESULTS: On final histopathology, 284 (48%) of the 596 low-risk patients were upgraded from a Gleason 6 biopsy score to 3⫹4 ⫽ 7 and 46 (9.1%) patients were upgraded to 4⫹3 ⫽ 7. Two patients were upgraded to Gleason 8/9. 32 (5.4%) patients were upstaged to pT3/4. In the group of AS patients, 130 (40%) of the 327 patients were upgraded to Gleason 3⫹4⫽ 7 and 11 (3.3%) patients were upgraded to 4⫹3⫽7, but none to Gleason 8 or higher.11 (3.3%) patients were upstaged to T3/4 disease, 3 of whom were also upgraded. Bilateral nerve sparing was performed on 97% of patients in the AS cohort. At 12