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POD-3.01: Intermittent Androgen Suppression Delayed the Time to PSA Failure in Locally-Advanced and Metastatic Prostate Cancer Compared with Continuous Androgen Suppression in Japan
PODIUM SESSIONS
total and 8 partial) was required for 8 local failures and 2 necroses, for an actuarial penile preservation rate at 5 years of 88% and10 years of 67%. The soft tissue necrosis rate is 12% and the urethral stenosis rate 9%. Six of 11 regional failures were salvaged by lymph node dissection ⫹/- external radiation. The other 5 regional failures had concurrent distant failure and died of disease. Among MD or PD tumors, 48.5% have failed regionally or distantly as compared to 3% of WD. Grade is a significant determinant of disease-free survival (p⫽0.005). Conclusions: Brachytherapy is an effective treatment for T1, T2 and selected T3 SCC of the penis, providing penile preservation in 88% at 5 years. Close follow-up is mandatory as local failures and many regional failures can be salvaged by surgery.
Podium Session POD-3: Prostate Cancer, Advanced Disease Friday, November 21 1115-1230 POD-3.01 Intermittent Androgen Suppression Delayed the Time to PSA Failure in Locally-Advanced and Metastatic Prostate Cancer Compared with Continuous Androgen Suppression in Japan Sato N1, Nakatsu H2, Akakura K3, Suzuki H4, Ichikawa T4 1 National Hospital Organization, Chiba Medical Center, Chiba, Japan; 2Asahi General Hospital, Chiba, Japan; 3Tokyo Kosei-Nenkin Hospital, Tokyo, Japan; 4 Chiba University Hospital, Chiba, Japan
Table 1, POD-3.01. Characteristics of the IAS and CAS Group Group (n) Median Age Pre-treatment PSA (ng/ml) PSA at 24 weeks (ng/ml) Gleason score Observation period (months)
IAS (51) 74.0 35.7
CAS (45) 75.0 31.0
⬍0.2
0.2
7.0 60.1
7.0 76.3
treatment level. This cycle of on-and-off treatment was repeated until PSA failure (three consecutive PSA increases during on-treatment period). In the CAS group, patients were retrospectively selected by matching age, pre-treatment PSA, PSA at 24 weeks, and Gleason score. Results: The characteristics of patients are summarized in Table 1. PSA failure was observed in 16% of the IAS group after 38.0 months on average, compared with 42% of the CAS group after 35.9 months. With the Kaplan-Meier curve, log-rank test (figure 1) revealed that time to PSA failure was significantly elongated in the IAS group. Cancer-specific death was observed in 7% of the CAS group compared with 2% of the IAS group (p⫽n.s.). Conclusions: In this study, CAS patients were neither randomized nor prospectively assigned, although IAS patients were treated prospectively. However, it is reliable because CAS patients were strictly selected to match with the IAS patients. Therefore, it was suggested that our IAS regimen enables us to delay the time to PSA failure.
Introduction and Objectives: We examined whether intermittent androgen suppression (IAS) prolonged the time to PSA failure compared with continuous androgen suppression (CAS) in a multi-center study. Materials and Methods: Patients with locally advanced (T3N0M0) and metastatic (TxN1M0, TxNxM1) prostate cancer were treated with a combination of LH-RH agonist and oral anti-androgens. When PSA levels at 24 weeks were ⬍4.0 ng/ml, patients were enrolled in this study. In the IAS group, all treatments were intentionally ceased at 36 weeks and resumed when PSA levels reached 15 ng/ml or pre-
UROLOGY 72 (Supplement 5A), November 2008
POD-3.02 Outcome of Patients with Positive Surgical Margins Following Radical Prostatectomy Treated with Adjuvant Hormonal and Radiation vs. Salvage Therapy: Selection Criteria Identified Bulbul M, Bou Diab N, El Hout Y, Houjeij A, Darwish O, Tawil A, Geara F Division of Urology, Department of Pathology and Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon Introduction and Objectives: Adjuvant radiation therapy (EBRT) has been the standard treatment in selected patients (pts) with positive surgical margins (PSM). Hormonal therapy (HT) has not been routinely integrated into the protocols though its significance has been demonstrated in medium- to high-risk pts with the intact prostate. We evaluated the outcome of selected pts with PSM receiving immediate HT and EBRT vs. pts managed expectantly and salvaged upon recurrence. Selection criteria for adjuvant therapy presented. Materials and Methods: Sixty-five pts with PSM following RRP were identified. Prostatic bed biopsies at the time of surgery were obtained in all cases. Based on specific selection criteria, 31/65 pts were selected for immediate adjuvant treatment and started on HT (total six months) followed by EBRT three months post op. Selection criteria included: positive seminal vesicles, Gleason score ⬎8, multiple significant margins (⬎3mm in more than 2 sites), and positive prostatic bed biopsy. There were 34/65 pts who were followed up expectantly. Follow-up included periodic PSA and DRE. Biochemical recurrence was defined as PSA ⬎ 0.2ng/ml.
1.0
IAS
0.8 0.6 0.4
CAS
0.2 0.0
Log-rank test, p=0.0193 0
25
50
75
100
125
Months Figure 1, POD-3.01. Progression-free survival.
S37
total and 8 partial) was required for 8 local failures and 2 necroses, for an actuarial penile preservation rate at 5 years of 88% and10 years of 67%. The soft tissue necrosis rate is 12% and the urethral stenosis rate 9%. Six of 11 regional failures were salvaged by lymph node dissection ⫹/- external radiation. The other 5 regional failures had concurrent distant failure and died of disease. Among MD or PD tumors, 48.5% have failed regionally or distantly as compared to 3% of WD. Grade is a significant determinant of disease-free survival (p⫽0.005). Conclusions: Brachytherapy is an effective treatment for T1, T2 and selected T3 SCC of the penis, providing penile preservation in 88% at 5 years. Close follow-up is mandatory as local failures and many regional failures can be salvaged by surgery.
Podium Session POD-3: Prostate Cancer, Advanced Disease Friday, November 21 1115-1230 POD-3.01 Intermittent Androgen Suppression Delayed the Time to PSA Failure in Locally-Advanced and Metastatic Prostate Cancer Compared with Continuous Androgen Suppression in Japan Sato N1, Nakatsu H2, Akakura K3, Suzuki H4, Ichikawa T4 1 National Hospital Organization, Chiba Medical Center, Chiba, Japan; 2Asahi General Hospital, Chiba, Japan; 3Tokyo Kosei-Nenkin Hospital, Tokyo, Japan; 4 Chiba University Hospital, Chiba, Japan
Table 1, POD-3.01. Characteristics of the IAS and CAS Group Group (n) Median Age Pre-treatment PSA (ng/ml) PSA at 24 weeks (ng/ml) Gleason score Observation period (months)
IAS (51) 74.0 35.7
CAS (45) 75.0 31.0
⬍0.2
0.2
7.0 60.1
7.0 76.3
treatment level. This cycle of on-and-off treatment was repeated until PSA failure (three consecutive PSA increases during on-treatment period). In the CAS group, patients were retrospectively selected by matching age, pre-treatment PSA, PSA at 24 weeks, and Gleason score. Results: The characteristics of patients are summarized in Table 1. PSA failure was observed in 16% of the IAS group after 38.0 months on average, compared with 42% of the CAS group after 35.9 months. With the Kaplan-Meier curve, log-rank test (figure 1) revealed that time to PSA failure was significantly elongated in the IAS group. Cancer-specific death was observed in 7% of the CAS group compared with 2% of the IAS group (p⫽n.s.). Conclusions: In this study, CAS patients were neither randomized nor prospectively assigned, although IAS patients were treated prospectively. However, it is reliable because CAS patients were strictly selected to match with the IAS patients. Therefore, it was suggested that our IAS regimen enables us to delay the time to PSA failure.
Introduction and Objectives: We examined whether intermittent androgen suppression (IAS) prolonged the time to PSA failure compared with continuous androgen suppression (CAS) in a multi-center study. Materials and Methods: Patients with locally advanced (T3N0M0) and metastatic (TxN1M0, TxNxM1) prostate cancer were treated with a combination of LH-RH agonist and oral anti-androgens. When PSA levels at 24 weeks were ⬍4.0 ng/ml, patients were enrolled in this study. In the IAS group, all treatments were intentionally ceased at 36 weeks and resumed when PSA levels reached 15 ng/ml or pre-
UROLOGY 72 (Supplement 5A), November 2008
POD-3.02 Outcome of Patients with Positive Surgical Margins Following Radical Prostatectomy Treated with Adjuvant Hormonal and Radiation vs. Salvage Therapy: Selection Criteria Identified Bulbul M, Bou Diab N, El Hout Y, Houjeij A, Darwish O, Tawil A, Geara F Division of Urology, Department of Pathology and Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon Introduction and Objectives: Adjuvant radiation therapy (EBRT) has been the standard treatment in selected patients (pts) with positive surgical margins (PSM). Hormonal therapy (HT) has not been routinely integrated into the protocols though its significance has been demonstrated in medium- to high-risk pts with the intact prostate. We evaluated the outcome of selected pts with PSM receiving immediate HT and EBRT vs. pts managed expectantly and salvaged upon recurrence. Selection criteria for adjuvant therapy presented. Materials and Methods: Sixty-five pts with PSM following RRP were identified. Prostatic bed biopsies at the time of surgery were obtained in all cases. Based on specific selection criteria, 31/65 pts were selected for immediate adjuvant treatment and started on HT (total six months) followed by EBRT three months post op. Selection criteria included: positive seminal vesicles, Gleason score ⬎8, multiple significant margins (⬎3mm in more than 2 sites), and positive prostatic bed biopsy. There were 34/65 pts who were followed up expectantly. Follow-up included periodic PSA and DRE. Biochemical recurrence was defined as PSA ⬎ 0.2ng/ml.
1.0
IAS
0.8 0.6 0.4
CAS
0.2 0.0
Log-rank test, p=0.0193 0
25
50
75
100
125
Months Figure 1, POD-3.01. Progression-free survival.
S37