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Quality of Life and Efficacy for Stereotactic Body Radiotherapy for Treatment of Organ Confined Prostate Cancer
I. J. Radiation Oncology d Biology d Physics
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Volume 78, Number 3, Supplement, 2010
months, respectively. Biochemical response was rapid over the first 24 months of follow-up: mean pre-treatment and 12 and 24month post-treatment values were 6.9, 1.0, and 0.3 ng/mL, respectively. Conclusions: At this early follow-up point, prostate SBRT with electromagnetic tracking results in favorable HRQOL and toxicity outcomes. Author Disclosure: C.A. Mantz, None; E. Fernandez, None; I. Zucker, None; S. Harrison, None.
122
Five-year Outcome of Stereotactic Hypofractionated Accurate Radiotherapy of the Prostate (SHARP) for Patients with Low-risk Prostate Cancer
H. T. Pham1, G. Song1, K. Badiozamani1, M. Yao1, J. Corman1, R. A. Hsi2, B. Madsen2 1
Virginia Mason Medical Center, Seattle, WA, 2Peninsula Cancer Center, Poulsbo, WA
Purpose/Objective(s): To report the five-year tumor control and late toxicity outcomes of a phase I/II trial of SHARP for patients with low risk prostate cancer. Materials/Methods: From August 2000 to July 2004, forty patients were treated with SHARP for low-risk prostate cancer using 33.5 Gy in 5 daily fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions (a/b ratio of 1.5 Gy). All patients had Gleason score # 6 and PSA # 10 ng/mL. Treatment was delivered using six noncoplanar beams and daily stereotactic localization of the prostate with 3 implanted gold fiducials. Median patient age was 69 (50-82 years). The median follow- up period was 60 months (9- 96 months) with at least 5 years of follow-up in 65% of patients. Results: The overall 5- year (nadir + 2 ng/mL) biochemical relapse free survival rate was 93%. The ASTRO biochemical relapsefree survival rate was 71%. The 5- year overall survival rate was 75% and there were no known prostate cancer related deaths. Median PSA nadir value was 0.65 ng/mL (.23 - 5.67 ng/mL). Median time to PSA nadir was 24 months (6- 96 months). Benign PSA bump was observed in 22.5% of the patients. Late genitourinary (GU) toxicity was 37.5% (22.5% grade 1, 12.5% grade 2, and 2.5% grade 3). Late gastrointestinal (GI) toxicity was 30% (22.5% grade 1 and 7.5% grade 2). Median time to both GU and GI toxicity was 9 months. All GU and GI toxicities have resolved. of the 26 patients who were potent at the time of treatment, 50% reported impotency at a median follow-up of 60 months (9-96 months). Conclusions: SHARP for low risk prostate cancer was well tolerated with good local control rates at five years. This unique treatment technique deserves further investigation in a large scale clinical trial setting with consideration for dose escalation. Author Disclosure: H.T. Pham, None; G. Song, None; K. Badiozamani, None; M. Yao, None; J. Corman, None; R.A. Hsi, None; B. Madsen, None.
123
Quality of Life and Efficacy for Stereotactic Body Radiotherapy for Treatment of Organ Confined Prostate Cancer
A. J. Katz, M. Santoro New York Stereotactic Radiosurgery, New York, NY Purpose/Objective(s): The purpose of this study is to assess the efficacy and toxicity of stereotactic radiotherapy (SRT) for patients with organ-confined prostate cancer. Materials/Methods: Fifty patients with low- and intermediate-risk T1cN0M0 prostate carcinoma (Gleason score # 6, PSA \ 15 and . 10 ng/mL) received 5 fractions of 7 Gy SBRT to a total dose of 35 Gy delivered over 5 consecutive days. Mean patient age was 69.5 years and mean pre-treatment PSA was 5.7 ng/mL. All patients received 1500 mg of amifostine intrarectally prior to each SBRT fraction. Patients were treated to the 83-87% contour line with 5-mm margins added to the gross tumor volume at all borders except for the rectum where a 3-mm margin was added. During treatment, 4 gold fiducial seeds were continuously tracked. Toxicity was assessed using the Radiation Therapy Oncology Group toxicity scale; biochemical failure was assessed by the Phoenix criteria, and quality of life was assessed with the Expanded Prostate Cancer Index Composite Questionnaire (EPIC). Results: At a median follow-up of 42 months (range, 39-46 months) no biochemical failures have occurred. Three patients died of intercurrent disease. The median PSA at 42 months is 0.11 ng/mL (range, 0.01 - 1.4 ng/mL) and 42 of 47 patients have reached a PSA of 0.5 ng/mL or less. Toxicity has been minimal with no grade 3+ toxicities. Actuarial 42-month Grade 2 urinary and rectal toxicityfree survival were 95.5% and 97.8%, respectively. EPIC bowel and urinary quality of life returned to baseline by 18 months and remained at baseline values at 36 months. of the 36 patients that were potent prior to treatment 29 (80.5%) maintained potency. Conclusions: At 42 months’ median follow-up the absence of any biochemical failures, the minimal toxicity and the promising potency preservation rates are highly encouraging. Author Disclosure: A.J. Katz, None; M. Santoro, None.
124
Preliminary Report of a Randomized Dose Escalation Trial for Prostate Cancer using Hypofractionation
D. A. Kuban, G. M. Nogueras-Gonzalez, L. Hamblin, A. K. Lee, S. Choi, S. J. Frank, Q. N. Nguyen, K. E. Hoffman, S. E. McGuire, M. F. Munsell M.D. Anderson Cancer Center, Houston, TX Purpose/Objective(s): To report outcome and toxicity for patients treated on a Phase III randomized radiation dose-escalation trial for localized prostate cancer using hypofractionation. Materials/Methods: From 2001 - 2010, 204 patients were treated on a randomized dose-escalation trial using IMRT and US-guided prostate localization, 102 patients on the conventional arm (CIMRT) to a dose of 75.6 Gy in 42 fractions and 102 on the hypofractionated arm (HIMRT) to a dose of 72 Gy in 30 fractions (85 Gy BED using alpha/beta 1.5). 29% of patients were low, 70% intermediate,
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Volume 78, Number 3, Supplement, 2010
months, respectively. Biochemical response was rapid over the first 24 months of follow-up: mean pre-treatment and 12 and 24month post-treatment values were 6.9, 1.0, and 0.3 ng/mL, respectively. Conclusions: At this early follow-up point, prostate SBRT with electromagnetic tracking results in favorable HRQOL and toxicity outcomes. Author Disclosure: C.A. Mantz, None; E. Fernandez, None; I. Zucker, None; S. Harrison, None.
122
Five-year Outcome of Stereotactic Hypofractionated Accurate Radiotherapy of the Prostate (SHARP) for Patients with Low-risk Prostate Cancer
H. T. Pham1, G. Song1, K. Badiozamani1, M. Yao1, J. Corman1, R. A. Hsi2, B. Madsen2 1
Virginia Mason Medical Center, Seattle, WA, 2Peninsula Cancer Center, Poulsbo, WA
Purpose/Objective(s): To report the five-year tumor control and late toxicity outcomes of a phase I/II trial of SHARP for patients with low risk prostate cancer. Materials/Methods: From August 2000 to July 2004, forty patients were treated with SHARP for low-risk prostate cancer using 33.5 Gy in 5 daily fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions (a/b ratio of 1.5 Gy). All patients had Gleason score # 6 and PSA # 10 ng/mL. Treatment was delivered using six noncoplanar beams and daily stereotactic localization of the prostate with 3 implanted gold fiducials. Median patient age was 69 (50-82 years). The median follow- up period was 60 months (9- 96 months) with at least 5 years of follow-up in 65% of patients. Results: The overall 5- year (nadir + 2 ng/mL) biochemical relapse free survival rate was 93%. The ASTRO biochemical relapsefree survival rate was 71%. The 5- year overall survival rate was 75% and there were no known prostate cancer related deaths. Median PSA nadir value was 0.65 ng/mL (.23 - 5.67 ng/mL). Median time to PSA nadir was 24 months (6- 96 months). Benign PSA bump was observed in 22.5% of the patients. Late genitourinary (GU) toxicity was 37.5% (22.5% grade 1, 12.5% grade 2, and 2.5% grade 3). Late gastrointestinal (GI) toxicity was 30% (22.5% grade 1 and 7.5% grade 2). Median time to both GU and GI toxicity was 9 months. All GU and GI toxicities have resolved. of the 26 patients who were potent at the time of treatment, 50% reported impotency at a median follow-up of 60 months (9-96 months). Conclusions: SHARP for low risk prostate cancer was well tolerated with good local control rates at five years. This unique treatment technique deserves further investigation in a large scale clinical trial setting with consideration for dose escalation. Author Disclosure: H.T. Pham, None; G. Song, None; K. Badiozamani, None; M. Yao, None; J. Corman, None; R.A. Hsi, None; B. Madsen, None.
123
Quality of Life and Efficacy for Stereotactic Body Radiotherapy for Treatment of Organ Confined Prostate Cancer
A. J. Katz, M. Santoro New York Stereotactic Radiosurgery, New York, NY Purpose/Objective(s): The purpose of this study is to assess the efficacy and toxicity of stereotactic radiotherapy (SRT) for patients with organ-confined prostate cancer. Materials/Methods: Fifty patients with low- and intermediate-risk T1cN0M0 prostate carcinoma (Gleason score # 6, PSA \ 15 and . 10 ng/mL) received 5 fractions of 7 Gy SBRT to a total dose of 35 Gy delivered over 5 consecutive days. Mean patient age was 69.5 years and mean pre-treatment PSA was 5.7 ng/mL. All patients received 1500 mg of amifostine intrarectally prior to each SBRT fraction. Patients were treated to the 83-87% contour line with 5-mm margins added to the gross tumor volume at all borders except for the rectum where a 3-mm margin was added. During treatment, 4 gold fiducial seeds were continuously tracked. Toxicity was assessed using the Radiation Therapy Oncology Group toxicity scale; biochemical failure was assessed by the Phoenix criteria, and quality of life was assessed with the Expanded Prostate Cancer Index Composite Questionnaire (EPIC). Results: At a median follow-up of 42 months (range, 39-46 months) no biochemical failures have occurred. Three patients died of intercurrent disease. The median PSA at 42 months is 0.11 ng/mL (range, 0.01 - 1.4 ng/mL) and 42 of 47 patients have reached a PSA of 0.5 ng/mL or less. Toxicity has been minimal with no grade 3+ toxicities. Actuarial 42-month Grade 2 urinary and rectal toxicityfree survival were 95.5% and 97.8%, respectively. EPIC bowel and urinary quality of life returned to baseline by 18 months and remained at baseline values at 36 months. of the 36 patients that were potent prior to treatment 29 (80.5%) maintained potency. Conclusions: At 42 months’ median follow-up the absence of any biochemical failures, the minimal toxicity and the promising potency preservation rates are highly encouraging. Author Disclosure: A.J. Katz, None; M. Santoro, None.
124
Preliminary Report of a Randomized Dose Escalation Trial for Prostate Cancer using Hypofractionation
D. A. Kuban, G. M. Nogueras-Gonzalez, L. Hamblin, A. K. Lee, S. Choi, S. J. Frank, Q. N. Nguyen, K. E. Hoffman, S. E. McGuire, M. F. Munsell M.D. Anderson Cancer Center, Houston, TX Purpose/Objective(s): To report outcome and toxicity for patients treated on a Phase III randomized radiation dose-escalation trial for localized prostate cancer using hypofractionation. Materials/Methods: From 2001 - 2010, 204 patients were treated on a randomized dose-escalation trial using IMRT and US-guided prostate localization, 102 patients on the conventional arm (CIMRT) to a dose of 75.6 Gy in 42 fractions and 102 on the hypofractionated arm (HIMRT) to a dose of 72 Gy in 30 fractions (85 Gy BED using alpha/beta 1.5). 29% of patients were low, 70% intermediate,