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Long-term Prostate Cancer Control (13 Year Actuarial) in Patients with a High Likelihood of Extracapsular Cancer Extension Using PD-103 Brachytherapy and Supplemental Beam Radiation
S298
I. J. Radiation Oncology
2115
● Biology ● Physics
Volume 63, Number 2, Supplement, 2005
Long-term Prostate Cancer Control (13 Year Actuarial) in Patients with a High Likelihood of Extracapsular Cancer Extension Using PD-103 Brachytherapy and Supplemental Beam Radiation
M.J. Dattoli,1 K. Wallner,2,3 L. True,4 J. Cash,1 R. Sorace1 Dattoli Cancer Center & Brachytherapy Research Institute, Sarasota, FL, 2Department of Radiation Oncology, University of Washington, Seattle, WA, 3Radiation Oncology, Puget Sound Health Care System - Department of Veteran Affairs, Seattle, WA, 4Department of Pathology, University of Washington, Seattle, WA
1
Purpose/Objective: To summarize long-term biochemical control rates with brachytherapy-based treatment for prostate cancer at high risk of having extracapsular cancer extension (ECE). Patients diagnosed with high risk prostate cancer are often discouraged from undergoing brachytherapy because of the lack of long-term follow-up data. Accordingly, we have updated our ongoing analysis of higher risk patients using strict biochemical criteria to determine patients cancer-free status. Materials/Methods: 282 consecutive patients with high risk prostate cancer were treated from 1992 through 1996 by one author (M.D.). Each patient had at least one higher risk feature of Gleason Score 7–10 (172 patients), PSA ⬎10 (166 patients). 113 patients met both high risk criteria. 67 patients also had elevated prostatic acid phosphatase (PAP). Clinical stage (109 patients with T2C and 107 patients with T3 disease)was not included in this data analysis to reduce subjectivity. Patients received a median 41 Gy 3D-CRT to a limited pelvic field (range 39 –54 Gy), followed by a Pd-103 boost (minimum peripheral dose 8000 –9000 cGy pre-NIST-99, median seed activity 1.4 mCi). Generous brachytherapy margins were utilized; the clinical target volume extended 0.5–1.0 cm antero-laterally to the TRUS prostate margin. 103 patients received neo-adjuvant or adjunctive hormones, median duration 4 months (maximum 6 months). Biochemical success was defined as a serum PSA ⱕ0.2 ng/ml at last follow-up, while patients whose PSAs nadired at a value of ⬎0.2 ng/ml were scored as failures. The follow-up period for non-failing patients ranged from 1–13 years (median: 9 years). Freedom from failure curves were calculated by the method of Kaplan-Meier. Differences between groups were determined by log-rank or students’ t-test. Biochemical data and original biopsy slides were independently re-reviewed at the University of Washington (K.W. and L. T. respectively). Results: The overall actuarial freedom from bio-chemical progression at 13 years is 81%, while the overall freedom-fromfailure for patients having both PSA ⬎10 and Gleason Score ⱖ7 was 74%. Of the 41 patients with biochemical failure, 27 (66%) failed within the first three years after treatment. The absolute risk of failure decreased progressively with time, falling to 1% beyond 5 years after treatment. Follow-up biopsies were performed on all failing patients. There were no pathologically documented local failures. The strongest predictor of failure was elevated PAP (p ⫽ 0.0001), followed by Gleason Score (p ⫽ 0.03) and PSA (p ⫽ 0.041). Hormones conferred no survival advantage (p ⫽ 0.9) although patients receiving hormones had the most adverse features. Treatment morbidity was limited to temporary RTOG grade 1–2 urinary symptoms. One patient who had both a TUIP and TURP post-treatment developed low-volume stress incontinence. No patient developed rectal ulceration. Conclusions: Evidence from this patient group at high risk for ECE suggests that high tumor control rates are possible when utilizing Pd-103 brachytherapy and supplemental beam radiation. It is encouraging that the failure rate decreased to near zero with follow-up beyond 5 years. Despite a perception that brachytherapy is not appropriate for patients at high risk of ECE, this series strengthens the rationale that brachytherapy-based treatment may, in fact, be a very desirable treatment modality for such patients.
2116
Prostate Brachytherapy in Twenty-Four Patients With Inflammatory Bowel Disease
C.A. Peters,1 M.J. Smith,1 N.N. Stone,2,1 R.G. Stock1 Radiation Oncology, Mount Sinai School of Medicine, New York, NY, 2Urology, Mount Sinai School of Medicine, New York, NY 1
Purpose/Objective: There is widespread concern and a paucity of data regarding the tolerability of prostate brachytherapy in patients with inflammatory bowel disease (IBD). The largest report includes 6 patients who underwent I-125 prostate seed implantation for early stage prostate cancer. In an effort to provide additional data as to the safety and feasibility of brachytherapy in this population, we report on the follow-up of 24 patients with a prior history of IBD treated with brachytherapy for early stage prostate cancer at a single institution. Materials/Methods: Twenty-four patients with a history of inflammatory bowel disease [17 with ulcerative colitis (UC), 7 with Crohn’s disease (CD)] underwent prostate brachytherapy between 1992 and 2004. None of the patients had active IBD in the rectum at the time of implant. Patients were identified from a prospective database of 2400 patients treated from June 1990 to the present. 15 patients had I-125 implantation and 9 patients had Pd-103 implantation, including 3 partial Pd-103 implants given in combination with external radiation (45 Gy). All patients had clinical stages T1c-T2b adenocarcinoma of the prostate. The prescription dose was based on real-time intraoperative planning and was 160 Gy (TG 43) for I-125 implants, 124 Gy (NIST 99) for full Pd-103 implants, and 100 Gy (NIST 99) for partial Pd-103 implants. Charts were reviewed for all patients, and all living patients were contacted by phone, except one patient who died of causes unrelated to prostate cancer. Pre and post-implant rectal bleeding and change in bowel habits were evaluated for all patients. Follow-up ranged from 3 to 119 months (median 48.5 months; mean 56.8 months). Results: Twenty-two of twenty-four patients did not experience any rectal bleeding or change in rectal bleeding from their pre-implant baseline. Of the two patients with a worsening of bleeding post-implant, one patient had colonoscopy documented radiation proctitis and had a mild clinical course, consisting of bleeding once/month on average for 3 months. He has not had any bleeding over the last 18 months. The other patient experienced a severe exacerbation of symptoms within two weeks of I-125 implantation, with bloody diarrhea daily for six months, progressively decreasing to baseline at 1 year. One patient developed a rectal fissure treated with Botox, presumed related to either brachytherapy or his Crohn’s disease. He is currently not taking any medication for his IBD and has no rectal bleeding. All other patients reported no other change in bowel habits post-implantation. The mean V100 to the rectum was 0.996cc. The mean D90 for I-125 was 185.30 Gy. The mean D90 for full Pd-103 was 129.62 Gy and for partial implants was 109.06 Gy. Conclusions: Prostate brachytherapy is generally well tolerated and appears to be safe in patients with a history of IBD. These favorable results may in part be explained by the low radiation doses delivered to the rectum following the use of the real-time seed implant method. As one patient experienced a particularly troublesome post-implant course, it will be helpful to distinguish clinical and genetic features that may be predictive of increased side effects.
I. J. Radiation Oncology
2115
● Biology ● Physics
Volume 63, Number 2, Supplement, 2005
Long-term Prostate Cancer Control (13 Year Actuarial) in Patients with a High Likelihood of Extracapsular Cancer Extension Using PD-103 Brachytherapy and Supplemental Beam Radiation
M.J. Dattoli,1 K. Wallner,2,3 L. True,4 J. Cash,1 R. Sorace1 Dattoli Cancer Center & Brachytherapy Research Institute, Sarasota, FL, 2Department of Radiation Oncology, University of Washington, Seattle, WA, 3Radiation Oncology, Puget Sound Health Care System - Department of Veteran Affairs, Seattle, WA, 4Department of Pathology, University of Washington, Seattle, WA
1
Purpose/Objective: To summarize long-term biochemical control rates with brachytherapy-based treatment for prostate cancer at high risk of having extracapsular cancer extension (ECE). Patients diagnosed with high risk prostate cancer are often discouraged from undergoing brachytherapy because of the lack of long-term follow-up data. Accordingly, we have updated our ongoing analysis of higher risk patients using strict biochemical criteria to determine patients cancer-free status. Materials/Methods: 282 consecutive patients with high risk prostate cancer were treated from 1992 through 1996 by one author (M.D.). Each patient had at least one higher risk feature of Gleason Score 7–10 (172 patients), PSA ⬎10 (166 patients). 113 patients met both high risk criteria. 67 patients also had elevated prostatic acid phosphatase (PAP). Clinical stage (109 patients with T2C and 107 patients with T3 disease)was not included in this data analysis to reduce subjectivity. Patients received a median 41 Gy 3D-CRT to a limited pelvic field (range 39 –54 Gy), followed by a Pd-103 boost (minimum peripheral dose 8000 –9000 cGy pre-NIST-99, median seed activity 1.4 mCi). Generous brachytherapy margins were utilized; the clinical target volume extended 0.5–1.0 cm antero-laterally to the TRUS prostate margin. 103 patients received neo-adjuvant or adjunctive hormones, median duration 4 months (maximum 6 months). Biochemical success was defined as a serum PSA ⱕ0.2 ng/ml at last follow-up, while patients whose PSAs nadired at a value of ⬎0.2 ng/ml were scored as failures. The follow-up period for non-failing patients ranged from 1–13 years (median: 9 years). Freedom from failure curves were calculated by the method of Kaplan-Meier. Differences between groups were determined by log-rank or students’ t-test. Biochemical data and original biopsy slides were independently re-reviewed at the University of Washington (K.W. and L. T. respectively). Results: The overall actuarial freedom from bio-chemical progression at 13 years is 81%, while the overall freedom-fromfailure for patients having both PSA ⬎10 and Gleason Score ⱖ7 was 74%. Of the 41 patients with biochemical failure, 27 (66%) failed within the first three years after treatment. The absolute risk of failure decreased progressively with time, falling to 1% beyond 5 years after treatment. Follow-up biopsies were performed on all failing patients. There were no pathologically documented local failures. The strongest predictor of failure was elevated PAP (p ⫽ 0.0001), followed by Gleason Score (p ⫽ 0.03) and PSA (p ⫽ 0.041). Hormones conferred no survival advantage (p ⫽ 0.9) although patients receiving hormones had the most adverse features. Treatment morbidity was limited to temporary RTOG grade 1–2 urinary symptoms. One patient who had both a TUIP and TURP post-treatment developed low-volume stress incontinence. No patient developed rectal ulceration. Conclusions: Evidence from this patient group at high risk for ECE suggests that high tumor control rates are possible when utilizing Pd-103 brachytherapy and supplemental beam radiation. It is encouraging that the failure rate decreased to near zero with follow-up beyond 5 years. Despite a perception that brachytherapy is not appropriate for patients at high risk of ECE, this series strengthens the rationale that brachytherapy-based treatment may, in fact, be a very desirable treatment modality for such patients.
2116
Prostate Brachytherapy in Twenty-Four Patients With Inflammatory Bowel Disease
C.A. Peters,1 M.J. Smith,1 N.N. Stone,2,1 R.G. Stock1 Radiation Oncology, Mount Sinai School of Medicine, New York, NY, 2Urology, Mount Sinai School of Medicine, New York, NY 1
Purpose/Objective: There is widespread concern and a paucity of data regarding the tolerability of prostate brachytherapy in patients with inflammatory bowel disease (IBD). The largest report includes 6 patients who underwent I-125 prostate seed implantation for early stage prostate cancer. In an effort to provide additional data as to the safety and feasibility of brachytherapy in this population, we report on the follow-up of 24 patients with a prior history of IBD treated with brachytherapy for early stage prostate cancer at a single institution. Materials/Methods: Twenty-four patients with a history of inflammatory bowel disease [17 with ulcerative colitis (UC), 7 with Crohn’s disease (CD)] underwent prostate brachytherapy between 1992 and 2004. None of the patients had active IBD in the rectum at the time of implant. Patients were identified from a prospective database of 2400 patients treated from June 1990 to the present. 15 patients had I-125 implantation and 9 patients had Pd-103 implantation, including 3 partial Pd-103 implants given in combination with external radiation (45 Gy). All patients had clinical stages T1c-T2b adenocarcinoma of the prostate. The prescription dose was based on real-time intraoperative planning and was 160 Gy (TG 43) for I-125 implants, 124 Gy (NIST 99) for full Pd-103 implants, and 100 Gy (NIST 99) for partial Pd-103 implants. Charts were reviewed for all patients, and all living patients were contacted by phone, except one patient who died of causes unrelated to prostate cancer. Pre and post-implant rectal bleeding and change in bowel habits were evaluated for all patients. Follow-up ranged from 3 to 119 months (median 48.5 months; mean 56.8 months). Results: Twenty-two of twenty-four patients did not experience any rectal bleeding or change in rectal bleeding from their pre-implant baseline. Of the two patients with a worsening of bleeding post-implant, one patient had colonoscopy documented radiation proctitis and had a mild clinical course, consisting of bleeding once/month on average for 3 months. He has not had any bleeding over the last 18 months. The other patient experienced a severe exacerbation of symptoms within two weeks of I-125 implantation, with bloody diarrhea daily for six months, progressively decreasing to baseline at 1 year. One patient developed a rectal fissure treated with Botox, presumed related to either brachytherapy or his Crohn’s disease. He is currently not taking any medication for his IBD and has no rectal bleeding. All other patients reported no other change in bowel habits post-implantation. The mean V100 to the rectum was 0.996cc. The mean D90 for I-125 was 185.30 Gy. The mean D90 for full Pd-103 was 129.62 Gy and for partial implants was 109.06 Gy. Conclusions: Prostate brachytherapy is generally well tolerated and appears to be safe in patients with a history of IBD. These favorable results may in part be explained by the low radiation doses delivered to the rectum following the use of the real-time seed implant method. As one patient experienced a particularly troublesome post-implant course, it will be helpful to distinguish clinical and genetic features that may be predictive of increased side effects.