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A multi-institutional Phase II trial for Cesium-131 permanent prostate brachytherapy
Abstracts / Brachytherapy 5 (2006) 78–117 balloon catheter (GliaSiteÔ RTS) into the resection cavity. Approximately, two weeks after surgery, the GliaSiteÔ device was loaded with the liquid I125 (Iotrex) radiation source through a subcutaneous port to deliver lowdose-rate brachytherapy. The median dwell time was 91.4 hours (range 70-169) which delivered an average dose of 50 Gy (range 38-70) to a depth of 5-10 mm from the balloon surface. Approximately, two weeks later this was followed by external beam radiation to an average dose of 58.7 Gy (46-60 Gy) allowing for a cumulative dose escalation of 108.7 Gy (84-130 Gy). Patient survival was compared to the median expected survival based on the Recursive Partitioning Analysis (RPA) classification. Results: The median survival for the 22 patients who received external beam radiation and GliaSiteÔ boost was 11 months (range 4-21 months), while 5 patients were still alive at time of analysis. When compared to their RPA class, the average increase in survival was 2.6 months (CI 0.234.9) which correlates to a 39% (p 5 0.033) increase. Three patients (14%) experienced RTOG grade 1 CNS toxicity and three additional patients (14%) experienced RTOG grade 3 CNS toxicity, which included 2 cases of symptomatic radiation necrosis. The patterns of failure in patients receiving a GliaSiteÔ boost was local, within the tumor bed. Conclusions: This is the first report on the feasibility of GliaSiteÔ as a brachytherapy boost to the tumor bed as part of the initial management of glioblastoma multiforme. The results of this analysis suggest that the use of GliaSiteÔ RTS to dose escalate the tumor bed up to approximately 100 Gy is well tolerated and associated with minimal toxicity in the context of this fatal disease. The potential role of GliaSiteÔ for dose escalation in the initial treatment of glioblastoma multiforme may prove to be beneficial and warrants further investigation.
OR-4 Presentation Time: 10:30 AM Pretreatment PSA velocity is associated with freedom from biochemical recurrence of prostate cancer following low-dose-rate prostate brachytherapy alone Peter J Rossi, M.D.,1 Micheal A Papagikos, M.D.,1 Peter E Clark, M.D.,2 W. Robert Lee, M.D., M.A.1 1Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, NC; 2Urology, Wake Forest University School of Medicine, Winston Salem, NC. Purpose: Pretreatment PSA velocity has been associated with freedom from biochemical recurrence (FFBR) in men treated with radical prostatectomy and external beam radiation therapy for prostate cancer. The purpose of this report is to examine the relationship between pretreatment PSA velocity and FFBR in men with prostate cancer treated with low-dose-rate brachytherapy (LDRPB). Methods and Materials: The information in this report concerns 52 men treated with LDRPB alone between September 1997 and December 1999. This is a subset of 108 consecutively treated patients with 72 months or more followup. Inclusion criteria: two or more evaluable PSA values O3 months apart and !18 months prior to treatment. PSA velocity is calculated using the Prostate Nomogram - PSA Doubling Time tool from the Memorial Sloan-Kettering Cancer Center website. All patients had biopsy confirmed, clinically localized prostate cancer. All men were treated with I-125 LDRPB according to the methods described by Blasko and Grimm. The prescription dose was 144 Gy (TG-43). LDRPB was performed jointly by a radiation oncologist and urologist. FFBR is determined using ASTRO Consensus Definition. FFBR is estimated using Kaplan-Meier method. Pretreatment PSA velocity is stratified by less than or greater than 2 nanogram per milliliter per year (ng/mL/yr). P-values are two-sided. Results: The median followup period is 61 months and median age at treatment is 67.5 years. The median pretreatment PSA is 6.45 (range 1.820.6), 75% of men (39/52) had nonpalpable disease, and 88% (46/52) had Gleason score <6. Five men (10%) developed evidence of biochemical recurrence at a median of 19 months (range 6-36 months). The six-year estimate of FFBR is 90% (95% CI 90-92%) for the entire cohort. On univariate analysis, pretreatment PSA velocity is associated with FFBR. The six-year estimate of FFBR in patients with a PSA velocity !2 ng/mL/ yr is 100% versus 80% (95% CI 80-85%) when the pretreatment PSA velocity is >2 ng/mL/yr in the year prior to LDRPB (p 5 0.017).
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Conclusions: Pretreatment PSA velocity is an important predictor of FFBR following LDRPB alone in this low-risk population of men with prostate cancer. We showed that a 2 ng/mL/yr or greater increase in PSA level during the year prior to diagnosis and treatment is associated with a significantly higher risk of PSA failure. Men with pretreatment PSA velocity >2 ng/mL/yr warrant more aggressive treatment. OR-5 Presentation Time: 10:40 AM A multi-institutional Phase II trial for Cesium-131 permanent prostate brachytherapy Bradley Prestidge, M.D.,1,2 William Bice, Ph.D.,2,3 Ines Jurkovic, M.S.,2,3 Brian Moran, M.D.,4 Donald Fuller, M.D.,5 James Gray, M.D.,6 David Beyer, M.D.,7 Steven Kurtzman, M.D.,8 John Sylvester, M.D.,9 Amir Sadeghi, Ph.D.1,2 1Radiation Oncology, Texas Cancer Clinic, San Antonio, TX; 2Radiation Oncology, Southwest Cancer Foundation, San Antonio, TX; 3Radiation Oncology, University of Texas Health Science Center at San Antonio, San Antonio, TX; 4Radiation Oncology, Chicago Prostate Institute, Chicago, IL; 5Radiation Oncology, Radiation Medical Group, San Diego, CA; 6Radiation Oncology, Centennial Medical Center, Nashville, TN; 7Radiation Oncology, Scottsdale Radiation Oncology, Scottsdale, AZ; 8Radiation Oncology, Mills-Peninsula Health Services, San Mateo, CA; 9Radiation Oncology, Seattle Prostate Institute, Seattle, WA. Purpose: A phase II trial using Cs-131 sources for permanent prostate brachytherapy was started at several cooperative institutions. Each collects and submits data in accordance with the protocol. The rationale and established implant characteristics have been described. Accrual is now more than 60% complete. This report serves as the collective analysis of the patient results of the trial to date. Methods and Materials: 61 patients at nine different institutions have undergone Cs-131 prostate brachytherapy prescribed to 100 Gy, following the treatment protocol. Post-implant dosimetry form day-0 CT scans of these implants was performed, generating dosimetric quantifiers as recommended by the ABS. IPS scores and urinary QOL scores were tabulated. Rectal symptoms were classified according to RTOG grading criteria. Results: Almost all patients experienced urinary symptoms, peaking at the two-week followup visit. Most returned to baseline values in 2-5 months. Urinary QOL and IPS scores confirmed this. Previous studies have shown an improvement in R100 for cesium over iodine, yet 25/50 patients reported rectal symptoms, 15 were Grade 1; the most common complaint was mild diarrhea. Of the 9 patients who experienced Grade 2 symptoms, rectal bleeding appeared most frequently. One patients experienced rectal, perineal and pelvic pain, classified as a Grade 3 symptom which has not resolved two months post implant. With 1 exception rectal symptoms appeared prior to the 1 month followup, the average duration was less than 2 months. Almost 80% of potent patients experienced a rapid decrease in sexual function within the first month. By four months post implant almost 80% of these IIEF scores were within a few points of pre-implant levels. Conclusions: The initial experience using Cs-131 for permanent prostate brachytherapy is encouraging. Patients treated under this protocol have tolerated the procedure well. Most experience symptoms, almost all resolve rapidly. The research protocol described in the submission is funded by Isoray Medical, Inc. OR-6 Presentation Time: 10:50 AM External beam radiotherapy in comparison to brachytherapy in the prevention of restenosis after femoropopliteal artery angioplasty David Donath, M.D.,1 Eric Therasse, M.D.,2 Gilles Soulez, M.D.,2 Jacques Lesperance, M.D.,3 Marie Giroux, M.D.,2 Jean-Claude Tardif, M.D.,4 Vincent Oliva, M.D.2 1Radiation Oncology, University of Montreal Medical Center, Montreal, QC, Canada; 2Radiology, University of Montreal Medical Center, Montreal, QC, Canada; 3Radiology, Montreal Heart Institute, Montreal, QC, Canada; 4Medicine, Montreal Heart Institute, Montreal, QC, Canada. Purpose: Prior studies have suggested that vascular brachytherapy (VBT) can reduce restenosis after percutaneous transluminal angioplasty (PTA)
OR-4 Presentation Time: 10:30 AM Pretreatment PSA velocity is associated with freedom from biochemical recurrence of prostate cancer following low-dose-rate prostate brachytherapy alone Peter J Rossi, M.D.,1 Micheal A Papagikos, M.D.,1 Peter E Clark, M.D.,2 W. Robert Lee, M.D., M.A.1 1Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, NC; 2Urology, Wake Forest University School of Medicine, Winston Salem, NC. Purpose: Pretreatment PSA velocity has been associated with freedom from biochemical recurrence (FFBR) in men treated with radical prostatectomy and external beam radiation therapy for prostate cancer. The purpose of this report is to examine the relationship between pretreatment PSA velocity and FFBR in men with prostate cancer treated with low-dose-rate brachytherapy (LDRPB). Methods and Materials: The information in this report concerns 52 men treated with LDRPB alone between September 1997 and December 1999. This is a subset of 108 consecutively treated patients with 72 months or more followup. Inclusion criteria: two or more evaluable PSA values O3 months apart and !18 months prior to treatment. PSA velocity is calculated using the Prostate Nomogram - PSA Doubling Time tool from the Memorial Sloan-Kettering Cancer Center website. All patients had biopsy confirmed, clinically localized prostate cancer. All men were treated with I-125 LDRPB according to the methods described by Blasko and Grimm. The prescription dose was 144 Gy (TG-43). LDRPB was performed jointly by a radiation oncologist and urologist. FFBR is determined using ASTRO Consensus Definition. FFBR is estimated using Kaplan-Meier method. Pretreatment PSA velocity is stratified by less than or greater than 2 nanogram per milliliter per year (ng/mL/yr). P-values are two-sided. Results: The median followup period is 61 months and median age at treatment is 67.5 years. The median pretreatment PSA is 6.45 (range 1.820.6), 75% of men (39/52) had nonpalpable disease, and 88% (46/52) had Gleason score <6. Five men (10%) developed evidence of biochemical recurrence at a median of 19 months (range 6-36 months). The six-year estimate of FFBR is 90% (95% CI 90-92%) for the entire cohort. On univariate analysis, pretreatment PSA velocity is associated with FFBR. The six-year estimate of FFBR in patients with a PSA velocity !2 ng/mL/ yr is 100% versus 80% (95% CI 80-85%) when the pretreatment PSA velocity is >2 ng/mL/yr in the year prior to LDRPB (p 5 0.017).
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Conclusions: Pretreatment PSA velocity is an important predictor of FFBR following LDRPB alone in this low-risk population of men with prostate cancer. We showed that a 2 ng/mL/yr or greater increase in PSA level during the year prior to diagnosis and treatment is associated with a significantly higher risk of PSA failure. Men with pretreatment PSA velocity >2 ng/mL/yr warrant more aggressive treatment. OR-5 Presentation Time: 10:40 AM A multi-institutional Phase II trial for Cesium-131 permanent prostate brachytherapy Bradley Prestidge, M.D.,1,2 William Bice, Ph.D.,2,3 Ines Jurkovic, M.S.,2,3 Brian Moran, M.D.,4 Donald Fuller, M.D.,5 James Gray, M.D.,6 David Beyer, M.D.,7 Steven Kurtzman, M.D.,8 John Sylvester, M.D.,9 Amir Sadeghi, Ph.D.1,2 1Radiation Oncology, Texas Cancer Clinic, San Antonio, TX; 2Radiation Oncology, Southwest Cancer Foundation, San Antonio, TX; 3Radiation Oncology, University of Texas Health Science Center at San Antonio, San Antonio, TX; 4Radiation Oncology, Chicago Prostate Institute, Chicago, IL; 5Radiation Oncology, Radiation Medical Group, San Diego, CA; 6Radiation Oncology, Centennial Medical Center, Nashville, TN; 7Radiation Oncology, Scottsdale Radiation Oncology, Scottsdale, AZ; 8Radiation Oncology, Mills-Peninsula Health Services, San Mateo, CA; 9Radiation Oncology, Seattle Prostate Institute, Seattle, WA. Purpose: A phase II trial using Cs-131 sources for permanent prostate brachytherapy was started at several cooperative institutions. Each collects and submits data in accordance with the protocol. The rationale and established implant characteristics have been described. Accrual is now more than 60% complete. This report serves as the collective analysis of the patient results of the trial to date. Methods and Materials: 61 patients at nine different institutions have undergone Cs-131 prostate brachytherapy prescribed to 100 Gy, following the treatment protocol. Post-implant dosimetry form day-0 CT scans of these implants was performed, generating dosimetric quantifiers as recommended by the ABS. IPS scores and urinary QOL scores were tabulated. Rectal symptoms were classified according to RTOG grading criteria. Results: Almost all patients experienced urinary symptoms, peaking at the two-week followup visit. Most returned to baseline values in 2-5 months. Urinary QOL and IPS scores confirmed this. Previous studies have shown an improvement in R100 for cesium over iodine, yet 25/50 patients reported rectal symptoms, 15 were Grade 1; the most common complaint was mild diarrhea. Of the 9 patients who experienced Grade 2 symptoms, rectal bleeding appeared most frequently. One patients experienced rectal, perineal and pelvic pain, classified as a Grade 3 symptom which has not resolved two months post implant. With 1 exception rectal symptoms appeared prior to the 1 month followup, the average duration was less than 2 months. Almost 80% of potent patients experienced a rapid decrease in sexual function within the first month. By four months post implant almost 80% of these IIEF scores were within a few points of pre-implant levels. Conclusions: The initial experience using Cs-131 for permanent prostate brachytherapy is encouraging. Patients treated under this protocol have tolerated the procedure well. Most experience symptoms, almost all resolve rapidly. The research protocol described in the submission is funded by Isoray Medical, Inc. OR-6 Presentation Time: 10:50 AM External beam radiotherapy in comparison to brachytherapy in the prevention of restenosis after femoropopliteal artery angioplasty David Donath, M.D.,1 Eric Therasse, M.D.,2 Gilles Soulez, M.D.,2 Jacques Lesperance, M.D.,3 Marie Giroux, M.D.,2 Jean-Claude Tardif, M.D.,4 Vincent Oliva, M.D.2 1Radiation Oncology, University of Montreal Medical Center, Montreal, QC, Canada; 2Radiology, University of Montreal Medical Center, Montreal, QC, Canada; 3Radiology, Montreal Heart Institute, Montreal, QC, Canada; 4Medicine, Montreal Heart Institute, Montreal, QC, Canada. Purpose: Prior studies have suggested that vascular brachytherapy (VBT) can reduce restenosis after percutaneous transluminal angioplasty (PTA)