- Email: [email protected]
Quality of Life after Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: Five Year Results
S206
International Journal of Radiation Oncology Biology Physics
(MVA), stage T3a-T3b, PSA >20, IR and HR (versus LR group) were associated with worse BFFS, whereas only age > 70 years at diagnosis and stage T3a-T3b predicted worse OS. ADT was associated with improved BFFS, but not OS on MVA. The overall 17-year rates for BFFS, DMFS, DSS, and OS were 79%, 97%, 97%, and 72%, respectively. When stratified by the risk group, 17-year BFFS rates for LR, IR, and HR were 86%, 80%, and 65% (P < 0.00001), respectively, whereas OS rates for the same groups were 82%, 73%, and 60% (P Z 0.09). There was a significant decline in sexual function for the entire cohort: of those patients who were potent at baseline (n Z 320) only 25% remained potent by the last followup. Urinary symptoms or QOL were mainly unaffected: among patients with initial mild urinary symptoms (n Z 365) 86% retained mild symptoms, and among those who were satisfied with their QOL due to urinary symptoms (n Z 460) at presentation, 93% remained satisfied. Conclusion: To the best of our knowledge, this is the largest to-date singleinstitution analysis of long-term outcomes with prostate LDR-BT 10 years post-implantation. LDR-BT yields excellent survival rates, with 17year DSS of 97%. Notably, 18% of patients with biochemical relapse will fail more than 10 years after treatment which justifies their continued follow-up. Author Disclosure: S. Lazarev: None. M.R. Thompson: None. N.N. Stone: None. R.G. Stock: Independent Contractor; BARD. Honoraria; BARD.
scale scores were transformed linearly to a 0-100 scale, with higher scores representing better QOL. A mean score change of >5 points is defines as clinically relevant. Results: Mean bowel function and bother score changes of >5 points in comparison to baseline levels before treatment were found only at the end of RT (10-15 points; P < 0.01) for patients treated with a hydrogel spacer. Mean long-term urinary and bowel domain scores did hardy differ from baseline levels (<2 points). Not a single patient reported about a moderate or big problem with his bowel problems overall (see Table 1). Baseline patient characteristics were similar to patients who were treated without a spacer in the same time period (median age of 73 years in both groups, median prostate volume of 56cc with vs. 62cc without a spacer). Bowel domain score changes were higher (statistically not significant) in comparison to the patient group with a spacer, with mean bother score changes of 21 points at the end of RT, 8 points at two months, 7 points at 17 months and 6 points at 63 months after RT. A bowel bother score change >10 points was found in 6% vs. 32% (P<0.01) at 17 months and in 5% vs. 14% (P Z 0.2) at 63 months with vs. without a spacer. Conclusion: The first five-year quality of life results in a group of prostate cancer patients treated with a hydrogel spacer demonstrate excellent treatment tolerability, in particular regarding bowel problems. Further studies with dose-escalated or re-irradiation concepts can be encouraged. Author Disclosure: M. Pinkawa: None. V. Berneking: None. M. Schlenter: None. B. Krenkel: None. M.J. Eble: None.
1083 Quality of Life after Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: Five Year Results M. Pinkawa,1,2 V. Berneking,1 M. Schlenter,1 B. Krenkel,1 and M.J. Eble1; 1 Department of Radiation Oncology, RWTH Aachen University Hospital, Aachen, Germany, 2Department of Radiation Oncology, MediClin Robert Janker Klinik, Bonn, Germany Purpose/Objective(s): Long-term clinical results are needed to better define a possible benefit of spacers for prostate cancer radiotherapy (RT). The aim of this analysis was to evaluate quality of life changes up to five years after radiotherapy for prostate cancer with a hydrogel spacer. Materials/Methods: In the years 2010-2011, 114 patients received external beam radiotherapy to the prostate. Fifty-four patients were selected for a hydrogel injection before the beginning of RT. Treatment was performed with a five-field IMRT technique with daily ultrasound based image guidance, applying fractions of 2 Gy up to a total dose of 76 Gy (n Z 96) or 78 Gy (n Z 18, all with hydrogel). Patients were surveyed prospectively before RT, at the last day of RT, a median time of 2 months, 17 months and 63 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite; comprising 50 items concerning urinary, bowel, sexual and hormonal domains). The multi-item Abstract 1083; Table 1 With spacer Without spacer (n Z 54) (n Z 60) P-value Mean (quartiles) urinary 1 year -2 (-7;0;4) bother score change after RT Mean (quartiles) bowel -1 (0; 0; 0) bother score change Moderate/big problem 0% with bowel urgency Moderate/big problem 0% with bowel habits overall Mean (quartiles) urinary 5 years 0 (-5;0;7) bother score change after RT Mean (quartiles) bowel 1 (0;0;4) bother score change Moderate/big problem 0% with bowel urgency 0% Moderate/big problem with bowel habits overall
-3 (-11;-4;4)
0.49
7 (-4;0;14)
0.13
13%
<0.01
17%
<0.01
-3 (-9;-4;4)
0.22
6 (-4;0;11)
0.99
14%
0.01
7%
0.08
1084 Is Active Surveillance the Preferred Management for Men with Early-Stage Prostate Cancer? A Decision Analysis Using the Protect Trial T.J. Bledsoe,1 J.M. Stahl,1 S.B. Johnson,1 S.K. Nath,1 J.B. Yu,2 and N.H. Lester-Coll1; 1Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT, 2Department of Therapeutic Radiology, Yale School of Medicine, New Haven, CT Purpose/Objective(s): The optimal initial management of early-stage (low- and intermediate-risk) prostate cancer remains unknown. The recently published prostate testing for cancer and Treatment (ProtecT) trial randomized patients with early-stage prostate cancer to three common management strategies: active surveillance (AS), radical prostatectomy (RP), or radiotherapy with 3-6 months of androgen-suppression (RT). This study demonstrated increased rates of disease progression and metastatic disease as well as a trend toward increased rates of death from prostate cancer among men treated with AS. We used the disease outcomes and treatment toxicity results from the ProtecT trial to create a decision analytic model to compare the benefits of treatment against possible decrements in quality of life with AS, RP, and RT. Quality-adjusted life years (QALYs) was the primary endpoint. Materials/Methods: A Markov decision analysis model was calibrated to the results of the ProtecT trial. The model was used to compare quality adjusted life years (QALYs) among the three treatment approaches: AS, RP, and RT. Probabilities of disease progression, development of metastatic disease, prostate cancer mortality, all-cause mortality and treatment toxicities were derived from the ProtecT trial. Utilities were estimated from the published literature. We used 10 years of follow-up and a cycle length of one year. Sensitivity analyses were used to assess the impact of varying model assumptions. Results: Treatment with RT yielded 7.95 QALYs compared with 7.77 QALYs for RP and 7.29 QALYs for AS. RT was preferred in the base case and the majority of scenarios on sensitivity analyses. RT was preferred to RP unless the probability of sexual dysfunction among men undergoing RP was < 56% (base case: 83.5%) or the probability of sexual dysfunction of men undergoing RT was > 91% (base case: 72.6%). AS was favored over RP when the utility of AS was 0.93 and favored over RT when it was 0.97 (base case: 0.84). AS was preferred to RT only when the utility of no-evidence-of-disease without side effects after treatment was < 0.81 (base case: 0.92). Varying the rate of development of metastatic disease among men undergoing AS did not significantly affect model results.
International Journal of Radiation Oncology Biology Physics
(MVA), stage T3a-T3b, PSA >20, IR and HR (versus LR group) were associated with worse BFFS, whereas only age > 70 years at diagnosis and stage T3a-T3b predicted worse OS. ADT was associated with improved BFFS, but not OS on MVA. The overall 17-year rates for BFFS, DMFS, DSS, and OS were 79%, 97%, 97%, and 72%, respectively. When stratified by the risk group, 17-year BFFS rates for LR, IR, and HR were 86%, 80%, and 65% (P < 0.00001), respectively, whereas OS rates for the same groups were 82%, 73%, and 60% (P Z 0.09). There was a significant decline in sexual function for the entire cohort: of those patients who were potent at baseline (n Z 320) only 25% remained potent by the last followup. Urinary symptoms or QOL were mainly unaffected: among patients with initial mild urinary symptoms (n Z 365) 86% retained mild symptoms, and among those who were satisfied with their QOL due to urinary symptoms (n Z 460) at presentation, 93% remained satisfied. Conclusion: To the best of our knowledge, this is the largest to-date singleinstitution analysis of long-term outcomes with prostate LDR-BT 10 years post-implantation. LDR-BT yields excellent survival rates, with 17year DSS of 97%. Notably, 18% of patients with biochemical relapse will fail more than 10 years after treatment which justifies their continued follow-up. Author Disclosure: S. Lazarev: None. M.R. Thompson: None. N.N. Stone: None. R.G. Stock: Independent Contractor; BARD. Honoraria; BARD.
scale scores were transformed linearly to a 0-100 scale, with higher scores representing better QOL. A mean score change of >5 points is defines as clinically relevant. Results: Mean bowel function and bother score changes of >5 points in comparison to baseline levels before treatment were found only at the end of RT (10-15 points; P < 0.01) for patients treated with a hydrogel spacer. Mean long-term urinary and bowel domain scores did hardy differ from baseline levels (<2 points). Not a single patient reported about a moderate or big problem with his bowel problems overall (see Table 1). Baseline patient characteristics were similar to patients who were treated without a spacer in the same time period (median age of 73 years in both groups, median prostate volume of 56cc with vs. 62cc without a spacer). Bowel domain score changes were higher (statistically not significant) in comparison to the patient group with a spacer, with mean bother score changes of 21 points at the end of RT, 8 points at two months, 7 points at 17 months and 6 points at 63 months after RT. A bowel bother score change >10 points was found in 6% vs. 32% (P<0.01) at 17 months and in 5% vs. 14% (P Z 0.2) at 63 months with vs. without a spacer. Conclusion: The first five-year quality of life results in a group of prostate cancer patients treated with a hydrogel spacer demonstrate excellent treatment tolerability, in particular regarding bowel problems. Further studies with dose-escalated or re-irradiation concepts can be encouraged. Author Disclosure: M. Pinkawa: None. V. Berneking: None. M. Schlenter: None. B. Krenkel: None. M.J. Eble: None.
1083 Quality of Life after Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: Five Year Results M. Pinkawa,1,2 V. Berneking,1 M. Schlenter,1 B. Krenkel,1 and M.J. Eble1; 1 Department of Radiation Oncology, RWTH Aachen University Hospital, Aachen, Germany, 2Department of Radiation Oncology, MediClin Robert Janker Klinik, Bonn, Germany Purpose/Objective(s): Long-term clinical results are needed to better define a possible benefit of spacers for prostate cancer radiotherapy (RT). The aim of this analysis was to evaluate quality of life changes up to five years after radiotherapy for prostate cancer with a hydrogel spacer. Materials/Methods: In the years 2010-2011, 114 patients received external beam radiotherapy to the prostate. Fifty-four patients were selected for a hydrogel injection before the beginning of RT. Treatment was performed with a five-field IMRT technique with daily ultrasound based image guidance, applying fractions of 2 Gy up to a total dose of 76 Gy (n Z 96) or 78 Gy (n Z 18, all with hydrogel). Patients were surveyed prospectively before RT, at the last day of RT, a median time of 2 months, 17 months and 63 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite; comprising 50 items concerning urinary, bowel, sexual and hormonal domains). The multi-item Abstract 1083; Table 1 With spacer Without spacer (n Z 54) (n Z 60) P-value Mean (quartiles) urinary 1 year -2 (-7;0;4) bother score change after RT Mean (quartiles) bowel -1 (0; 0; 0) bother score change Moderate/big problem 0% with bowel urgency Moderate/big problem 0% with bowel habits overall Mean (quartiles) urinary 5 years 0 (-5;0;7) bother score change after RT Mean (quartiles) bowel 1 (0;0;4) bother score change Moderate/big problem 0% with bowel urgency 0% Moderate/big problem with bowel habits overall
-3 (-11;-4;4)
0.49
7 (-4;0;14)
0.13
13%
<0.01
17%
<0.01
-3 (-9;-4;4)
0.22
6 (-4;0;11)
0.99
14%
0.01
7%
0.08
1084 Is Active Surveillance the Preferred Management for Men with Early-Stage Prostate Cancer? A Decision Analysis Using the Protect Trial T.J. Bledsoe,1 J.M. Stahl,1 S.B. Johnson,1 S.K. Nath,1 J.B. Yu,2 and N.H. Lester-Coll1; 1Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT, 2Department of Therapeutic Radiology, Yale School of Medicine, New Haven, CT Purpose/Objective(s): The optimal initial management of early-stage (low- and intermediate-risk) prostate cancer remains unknown. The recently published prostate testing for cancer and Treatment (ProtecT) trial randomized patients with early-stage prostate cancer to three common management strategies: active surveillance (AS), radical prostatectomy (RP), or radiotherapy with 3-6 months of androgen-suppression (RT). This study demonstrated increased rates of disease progression and metastatic disease as well as a trend toward increased rates of death from prostate cancer among men treated with AS. We used the disease outcomes and treatment toxicity results from the ProtecT trial to create a decision analytic model to compare the benefits of treatment against possible decrements in quality of life with AS, RP, and RT. Quality-adjusted life years (QALYs) was the primary endpoint. Materials/Methods: A Markov decision analysis model was calibrated to the results of the ProtecT trial. The model was used to compare quality adjusted life years (QALYs) among the three treatment approaches: AS, RP, and RT. Probabilities of disease progression, development of metastatic disease, prostate cancer mortality, all-cause mortality and treatment toxicities were derived from the ProtecT trial. Utilities were estimated from the published literature. We used 10 years of follow-up and a cycle length of one year. Sensitivity analyses were used to assess the impact of varying model assumptions. Results: Treatment with RT yielded 7.95 QALYs compared with 7.77 QALYs for RP and 7.29 QALYs for AS. RT was preferred in the base case and the majority of scenarios on sensitivity analyses. RT was preferred to RP unless the probability of sexual dysfunction among men undergoing RP was < 56% (base case: 83.5%) or the probability of sexual dysfunction of men undergoing RT was > 91% (base case: 72.6%). AS was favored over RP when the utility of AS was 0.93 and favored over RT when it was 0.97 (base case: 0.84). AS was preferred to RT only when the utility of no-evidence-of-disease without side effects after treatment was < 0.81 (base case: 0.92). Varying the rate of development of metastatic disease among men undergoing AS did not significantly affect model results.