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Outcome analysis of prostate cancer patients treated with observation
Proceedings of the 44th Annual ASTRO Meeting
2104
Neoadjuvant Androgen Deprivation Increases the Risk of Acute Urinary Retention Following Low Dose Rate Prostate Brachytherapy
S.K. Tomlinson, W.R. Lee, D.L. McCullough, A.F. deGuzman Department of Radiation Oncology, Wake Forest University, Winston-Salem, NC Purpose/Objective: Low dose rate (LDRPB) has become an increasingly popular treatment choice for men with early-stage adenocarcinoma of the prostate. The purpose of this work is to identify factors predictive of acute urinary retention (AUR) following LDRPB. Materials/Methods: Between February 1997 and December 2001, 191 patients with stage T1c-T3a prostate cancer were treated with LDRPB at a single institution. A retrospective chart review was performed to determine the number of men that experienced AUR requiring catheterization. Logistic regression analysis was performed to determine variables that may predict for the development of AUR. Putative predictive variables included: patient age, pre-treatment PSA, Gleason score, American Urological Association (AUA) score, history of transurethral resection of the prostate (TURP), transrectal ultrasound prostate volume, the number of seeds, the use of external beam radiotherapy, and the use of neoadjuvant androgen deprivation therapy (NADT). Univariate and multivariate analyses were performed. Results: Forty-one patients (21.5%) developed acute urinary retention requiring catheterization following LDRPB. On univariate analysis the only variables that significantly predicted for AUR were AUA symptom score (p ⫽ 0.0068) and the use of NADT (p ⫽ 0.0356). The rate of AUR in men treated with NADT was 34.2% versus 18.2% in men treated with LDRPB alone. On multivariate analysis AUA symptom score (p ⫽ 0.0137) and NADT (p ⫽ 0.0347) were independent predictors of AUR. Conclusions: Higher AUA scores and the use of NADT are independent risk factors for AUR following LDRPB. Men with higher AUA scores and those treated with NADT should be counseled that they are a higher risk for the development of AUR.
2105
Outcome Analysis of Prostate Cancer Patients Treated with Observation
N.M. Kramer1, E.M. Horwitz1, A.L. Hanlon1, R.G. Uzzo2, G.E. Hanks1, A. Pollack1 1 Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, 2Department of Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA
Purpose/Objective: For many years observation has been an option for men with non-metastatic prostate cancer. However, appropriate selection of patients for observation and the natural history of PSA era prostate cancer patients are not well documented. In this study the outcome of PSA era patients with non-metastatic prostate cancer who underwent observation was examined and compared to a similar group of patients treated with 3D-conformal radiation therapy (3DCRT) alone. Materials/Methods: Between 1/1/92 and 11/30/99, 69 patients with non-metastatic prostate cancer underwent observation in our department. Patients had one or more indications for observation including indolent disease (51 patients), significant medical comorbidities (25 patients), and refusal of treatment (14 patients). Sixty-two patients had palpable T1-T2a disease (1992 AJCC staging) and 7 patients had T2b-T3a disease. The median Gleason score was 6 (range: 2-7). The mean and median PSA’s at initial consultation (iPSA) were 6.0 and 5.3 ng/mL, respectively (range:0.5-16). For 55 patients iPSA was ⬍10 and for 14 patients it was 10-16. Median age was 74 years. A matched pair analysis was also performed to compare clinical outcome between the observation patients and those treated with 3DCRT. Patients were matched based on palpation T category, Gleason score and iPSA. The median radiation dose for those treated with 3DCRT was 72 Gy (range: 63-76 Gy). Median age of the treated patients was 69 years. Clinical outcome and biochemical (bNED) control were estimated using Kaplan-Meier methodology. Results: Median follow-up for the observation patients was 49 months (range 5-98 months). The 5 and 8 year actuarial rates of freedom from distant metastases were 100% and 93%, respectively, with one patient developing bone metastases. Time to distant metastasis was 69 months. The 5 and 8 year actuarial overall survival rates were 94% and 73%, respectively. The mean and median PSA’s at last follow-up were 9.1 and 8.4 ng/mL, respectively (range:0.2-30.9). Six patients managed with observation experienced local progression of disease as determined by physical examination. Three patients initially treated with observation received radiation therapy later in their course of follow-up. The discontinuation of observation was recommended because of PSA status in 2 patients and the development of a palpable prostate nodule in one patient. Time from diagnosis of prostate cancer to start of radiation treatment in these 3 patients was 29 months, 23 months, and 16 months respectively. All 3 are currently biochemically and clinically free of disease at 15 months, 17 months, and 24 months status post completion of 3DCRT, respectively. For the 69 matched 3DCRT patients, the overall 5 year bNED rate was 74%. There were no significant differences in distant metastasis and overall survival rates between observation patients and 3DCRT patients in the matched pair analysis, and there were no deaths due to prostate cancer in either group. However, the median PSA doubling time was 60 months in the observation patients and 39 months in the 3DCRT patients (p⫽0.07). Another difference in the groups was median age, which was 74 years in the observation group and 69 years in the 3DCRT group (p⬍0.0001). Conclusions: The natural history of prostate cancer is typically extended, making observation a reasonable alternative to treatment in selected patients. At least during the 5 year follow-up period examined, progression rates were relatively low. Only one patient exhibited local progression warranting initiation of radiation therapy and only one patient experienced distant metastasis. Moreover, there was no difference in distant metastasis or overall survival in men treated with observation compared with those who received 3DCRT. While the two groups were evenly matched by the main prognostic factors, clear differences were evident in PSA doubling time and age. Another limitation of the study is that the duration of follow-up may not have been sufficient to fully appreciate the impact of observation on distant metastasis and overall survival.
273
2104
Neoadjuvant Androgen Deprivation Increases the Risk of Acute Urinary Retention Following Low Dose Rate Prostate Brachytherapy
S.K. Tomlinson, W.R. Lee, D.L. McCullough, A.F. deGuzman Department of Radiation Oncology, Wake Forest University, Winston-Salem, NC Purpose/Objective: Low dose rate (LDRPB) has become an increasingly popular treatment choice for men with early-stage adenocarcinoma of the prostate. The purpose of this work is to identify factors predictive of acute urinary retention (AUR) following LDRPB. Materials/Methods: Between February 1997 and December 2001, 191 patients with stage T1c-T3a prostate cancer were treated with LDRPB at a single institution. A retrospective chart review was performed to determine the number of men that experienced AUR requiring catheterization. Logistic regression analysis was performed to determine variables that may predict for the development of AUR. Putative predictive variables included: patient age, pre-treatment PSA, Gleason score, American Urological Association (AUA) score, history of transurethral resection of the prostate (TURP), transrectal ultrasound prostate volume, the number of seeds, the use of external beam radiotherapy, and the use of neoadjuvant androgen deprivation therapy (NADT). Univariate and multivariate analyses were performed. Results: Forty-one patients (21.5%) developed acute urinary retention requiring catheterization following LDRPB. On univariate analysis the only variables that significantly predicted for AUR were AUA symptom score (p ⫽ 0.0068) and the use of NADT (p ⫽ 0.0356). The rate of AUR in men treated with NADT was 34.2% versus 18.2% in men treated with LDRPB alone. On multivariate analysis AUA symptom score (p ⫽ 0.0137) and NADT (p ⫽ 0.0347) were independent predictors of AUR. Conclusions: Higher AUA scores and the use of NADT are independent risk factors for AUR following LDRPB. Men with higher AUA scores and those treated with NADT should be counseled that they are a higher risk for the development of AUR.
2105
Outcome Analysis of Prostate Cancer Patients Treated with Observation
N.M. Kramer1, E.M. Horwitz1, A.L. Hanlon1, R.G. Uzzo2, G.E. Hanks1, A. Pollack1 1 Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, 2Department of Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA
Purpose/Objective: For many years observation has been an option for men with non-metastatic prostate cancer. However, appropriate selection of patients for observation and the natural history of PSA era prostate cancer patients are not well documented. In this study the outcome of PSA era patients with non-metastatic prostate cancer who underwent observation was examined and compared to a similar group of patients treated with 3D-conformal radiation therapy (3DCRT) alone. Materials/Methods: Between 1/1/92 and 11/30/99, 69 patients with non-metastatic prostate cancer underwent observation in our department. Patients had one or more indications for observation including indolent disease (51 patients), significant medical comorbidities (25 patients), and refusal of treatment (14 patients). Sixty-two patients had palpable T1-T2a disease (1992 AJCC staging) and 7 patients had T2b-T3a disease. The median Gleason score was 6 (range: 2-7). The mean and median PSA’s at initial consultation (iPSA) were 6.0 and 5.3 ng/mL, respectively (range:0.5-16). For 55 patients iPSA was ⬍10 and for 14 patients it was 10-16. Median age was 74 years. A matched pair analysis was also performed to compare clinical outcome between the observation patients and those treated with 3DCRT. Patients were matched based on palpation T category, Gleason score and iPSA. The median radiation dose for those treated with 3DCRT was 72 Gy (range: 63-76 Gy). Median age of the treated patients was 69 years. Clinical outcome and biochemical (bNED) control were estimated using Kaplan-Meier methodology. Results: Median follow-up for the observation patients was 49 months (range 5-98 months). The 5 and 8 year actuarial rates of freedom from distant metastases were 100% and 93%, respectively, with one patient developing bone metastases. Time to distant metastasis was 69 months. The 5 and 8 year actuarial overall survival rates were 94% and 73%, respectively. The mean and median PSA’s at last follow-up were 9.1 and 8.4 ng/mL, respectively (range:0.2-30.9). Six patients managed with observation experienced local progression of disease as determined by physical examination. Three patients initially treated with observation received radiation therapy later in their course of follow-up. The discontinuation of observation was recommended because of PSA status in 2 patients and the development of a palpable prostate nodule in one patient. Time from diagnosis of prostate cancer to start of radiation treatment in these 3 patients was 29 months, 23 months, and 16 months respectively. All 3 are currently biochemically and clinically free of disease at 15 months, 17 months, and 24 months status post completion of 3DCRT, respectively. For the 69 matched 3DCRT patients, the overall 5 year bNED rate was 74%. There were no significant differences in distant metastasis and overall survival rates between observation patients and 3DCRT patients in the matched pair analysis, and there were no deaths due to prostate cancer in either group. However, the median PSA doubling time was 60 months in the observation patients and 39 months in the 3DCRT patients (p⫽0.07). Another difference in the groups was median age, which was 74 years in the observation group and 69 years in the 3DCRT group (p⬍0.0001). Conclusions: The natural history of prostate cancer is typically extended, making observation a reasonable alternative to treatment in selected patients. At least during the 5 year follow-up period examined, progression rates were relatively low. Only one patient exhibited local progression warranting initiation of radiation therapy and only one patient experienced distant metastasis. Moreover, there was no difference in distant metastasis or overall survival in men treated with observation compared with those who received 3DCRT. While the two groups were evenly matched by the main prognostic factors, clear differences were evident in PSA doubling time and age. Another limitation of the study is that the duration of follow-up may not have been sufficient to fully appreciate the impact of observation on distant metastasis and overall survival.
273