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Intermediate Risk Prostate Cancer
Proceedings of the 53rd Annual ASTRO Meeting
2390
Comparing the Effectiveness of Low Dose Rate Brachytherapy, High Dose Rate Brachytherapy and Intensity Modulated Radiation Therapy for the Treatment of Low/Intermediate Risk Prostate Cancer
T. B. Lanni, M. I. Ghilezan, G. S. Gustafson, K. S. Marvin, H. Ye, F. A. Vicini, A. A. Martinez William Beaumont Hospital, Royal Oak, MI Purpose/Objective(s): To evaluate outcomes and cost effectiveness of low dose rate (LDR) and high dose rate (HDR) brachytherapy with intensity-modulated radiation therapy (IMRT) in low and intermediate risk prostate cancer patients. Materials/Methods: One thousand four hundred and thirty-six patients with low or intermediate prostate cancer were treated with LDR (n = 207), HDR with 2 fractions (n = 108), HDR with 4 fractions (n = 252), or IMRT (n = 869) between January 1992 and December 2008. LDR patients were treated with palladium seeds to a median dose of 120 Gy while HDR patients were treated to a median dose of 24.0 (2 fractions) and 38.0 Gy (4 fractions) respectively. IMRT patients received 42-44 fractions with a median dose of 75.6 Gy. The actual cost of each treatment course was calculated using hospital-based 2010 Medicare Ambulatory Payment Classification (APC) and physician fee screen reimbursement rates for both the technical and professional components of therapy. Clinical outcomes for LDR, HDR and IMRT were compared including biochemical failure, local recurrence, cause-specific survival, and overall survival. Results: The median follow-up time for all patients was 5.5 years. According to 2010 Medicare reimbursements, the cost in our patient population for LDR, HDR with 2 fractions, HDR with 4 fractions and IMRT was $8,187, $14,579, $16,484 and $25,910 respectively. HDR and LDR were statistically less costly then IMRT (p\0.001) with no difference between HDR regimens or between HDR regimens and LDR. No differences in biochemical failure or local recurrence were noted at 5 years between modalities. While there was a significant decrease in overall survival with IMRT and LDR compared with the HDR regimens, no difference in cause-specific mortality existed. Conclusions: In this study of low and intermediate prostate cancer patients, the Medicare reimbursement for IMRT was found to be significantly higher than that of other treatment regimens despite comparable 5 year biochemical control and cause-specific survival. Author Disclosure: T.B. Lanni: None. M.I. Ghilezan: None. G.S. Gustafson: None. K.S. Marvin: None. H. Ye: None. F.A. Vicini: None. A.A. Martinez: None.
2391
Neoadjuvant Radiotherapy plus Prostatectomy for High Risk Prostate Cancer
B. F. Koontz1, W. R. Lee1, Z. Vujaskovic1, M. Carroll1, B. P. Quaranta2, M. S. Anscher3, C. N. Robertson1, T. J. Polascik1, J. W. Moul1 1 Duke University Medical Center, Durham, NC, 221st Century Oncology, Asheville, NC, 3VIrginia Commonwealth University, Richmond, VA
Purpose/Objective(s): To determine the safety profile and early cancer outcomes of neoadjuvant whole pelvis radiotherapy (RT) followed immediately by radical retropubic prostatectomy (RP). Materials/Methods: Twelve patients diagnosed with high risk prostate cancer were enrolled and completed a phase I clinical trial of escalated dose neoadjuvant RT with RP performed within 8 weeks from RT completion. Three patients were enrolled on each of four dose levels: 39.6, 45, 50.4, and 54 Gy. Tumor burden at biopsy and prostatectomy, pathologic stage, margin status, radiation and surgical toxicities, and PSA outcome were evaluated. For comparison of operative characteristics and biochemical recurrence free survival (BRFS), a matching cohort (n = 36) was randomly selected from men who underwent the same surgical procedure during the same time period and later received either adjuvant or salvage RT. Biochemical failure was scored if post-treatment PSA was persistently . 0.2 ng/ml or if androgen deprivation was administered. Time to event was calculated from RP completion (neoadjuvant patients) or start of adjuvant/salvage RT. Statistical analysis by using two-sided student’s t-test and chi-square using JMP 9.0. Results: Median follow-up is 24 months, with a minimum follow-up of 8 months for neoadjuvant patients. No intra-operative morbidity was seen. Length of procedure was unchanged compared to the matched cohort (3.8 vs 3.8 h, p = 0.24); length of stay was slightly shorter for patients receiving neoadjuvant RT (median 1.9 vs 2.0 days, p = 0.02). Chronic urinary grade 2+ toxicities (CTCAE 2.0) occurred in 33% of neoadjuvant patients; one patient developed a symptomatic urethral stricture. 2 year actuarial BRFS was 66% for neoadjuvant patients and 67% for patients receiving adjuvant/salvage RT (p = 0.61). Conclusions: Multidisciplinary treatment including neoadjuvant RT followed by RP for high risk prostate cancer is safe and offers competitive biochemical control compared to a matched population undergoing post-operative RT. Evaluation of neoadjuvant radiotherapy in a phase II setting should be considered. Author Disclosure: B.F. Koontz: None. W.R. Lee: None. Z. Vujaskovic: None. M. Carroll: None. B.P. Quaranta: None. M.S. Anscher: None. C.N. Robertson: None. T.J. Polascik: None. J.W. Moul: None.
2392
Do Diabetic Patients Experience More Toxicity After External Beam Radiation Therapy For Prostate Cancer?
K. Kalakota1, D. Correa2, S. Liauw2 1
Northwestern University, Chicago, IL, 2University of Chicago, Chicago, IL
Purpose/Objective(s): To investigate the influence of diabetes mellitus (DM) on late genitourinary (GU) and gastrointestinal (GI) toxicity in patients treated with external beam radiation therapy (EBRT) for prostate cancer. Materials/Methods: 626 men were treated with curative-intent radiation therapy (RT) for prostate cancer between 1988 and 2008, and had a complete record of past medical history at the time of consultation. No patients had prostatectomy or brachytherapy. Median age was 69. By NCCN risk category, patients were classified as low (30%), intermediate (42%), or high-risk (29%). Median RT dose was 74 Gy. 52% were treated with Intensity-Modulated RT (IMRT), and 45% received androgen deprivation therapy (ADT) for a median 4 mo. 11% of patients had prior transurethral resection of the prostate (TURP). Late GU and GI RTOG toxicity was recorded at each follow-up 3 months after RT. Median follow-up was 57 mos. Results: 103 patients had DM at consultation (16%), which was either controlled by diet (8%), oral medications (52%), or insulin (39%). There were no differences between DM and non-DM patients with regard to age, PSA, risk classification, or TURP;
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2390
Comparing the Effectiveness of Low Dose Rate Brachytherapy, High Dose Rate Brachytherapy and Intensity Modulated Radiation Therapy for the Treatment of Low/Intermediate Risk Prostate Cancer
T. B. Lanni, M. I. Ghilezan, G. S. Gustafson, K. S. Marvin, H. Ye, F. A. Vicini, A. A. Martinez William Beaumont Hospital, Royal Oak, MI Purpose/Objective(s): To evaluate outcomes and cost effectiveness of low dose rate (LDR) and high dose rate (HDR) brachytherapy with intensity-modulated radiation therapy (IMRT) in low and intermediate risk prostate cancer patients. Materials/Methods: One thousand four hundred and thirty-six patients with low or intermediate prostate cancer were treated with LDR (n = 207), HDR with 2 fractions (n = 108), HDR with 4 fractions (n = 252), or IMRT (n = 869) between January 1992 and December 2008. LDR patients were treated with palladium seeds to a median dose of 120 Gy while HDR patients were treated to a median dose of 24.0 (2 fractions) and 38.0 Gy (4 fractions) respectively. IMRT patients received 42-44 fractions with a median dose of 75.6 Gy. The actual cost of each treatment course was calculated using hospital-based 2010 Medicare Ambulatory Payment Classification (APC) and physician fee screen reimbursement rates for both the technical and professional components of therapy. Clinical outcomes for LDR, HDR and IMRT were compared including biochemical failure, local recurrence, cause-specific survival, and overall survival. Results: The median follow-up time for all patients was 5.5 years. According to 2010 Medicare reimbursements, the cost in our patient population for LDR, HDR with 2 fractions, HDR with 4 fractions and IMRT was $8,187, $14,579, $16,484 and $25,910 respectively. HDR and LDR were statistically less costly then IMRT (p\0.001) with no difference between HDR regimens or between HDR regimens and LDR. No differences in biochemical failure or local recurrence were noted at 5 years between modalities. While there was a significant decrease in overall survival with IMRT and LDR compared with the HDR regimens, no difference in cause-specific mortality existed. Conclusions: In this study of low and intermediate prostate cancer patients, the Medicare reimbursement for IMRT was found to be significantly higher than that of other treatment regimens despite comparable 5 year biochemical control and cause-specific survival. Author Disclosure: T.B. Lanni: None. M.I. Ghilezan: None. G.S. Gustafson: None. K.S. Marvin: None. H. Ye: None. F.A. Vicini: None. A.A. Martinez: None.
2391
Neoadjuvant Radiotherapy plus Prostatectomy for High Risk Prostate Cancer
B. F. Koontz1, W. R. Lee1, Z. Vujaskovic1, M. Carroll1, B. P. Quaranta2, M. S. Anscher3, C. N. Robertson1, T. J. Polascik1, J. W. Moul1 1 Duke University Medical Center, Durham, NC, 221st Century Oncology, Asheville, NC, 3VIrginia Commonwealth University, Richmond, VA
Purpose/Objective(s): To determine the safety profile and early cancer outcomes of neoadjuvant whole pelvis radiotherapy (RT) followed immediately by radical retropubic prostatectomy (RP). Materials/Methods: Twelve patients diagnosed with high risk prostate cancer were enrolled and completed a phase I clinical trial of escalated dose neoadjuvant RT with RP performed within 8 weeks from RT completion. Three patients were enrolled on each of four dose levels: 39.6, 45, 50.4, and 54 Gy. Tumor burden at biopsy and prostatectomy, pathologic stage, margin status, radiation and surgical toxicities, and PSA outcome were evaluated. For comparison of operative characteristics and biochemical recurrence free survival (BRFS), a matching cohort (n = 36) was randomly selected from men who underwent the same surgical procedure during the same time period and later received either adjuvant or salvage RT. Biochemical failure was scored if post-treatment PSA was persistently . 0.2 ng/ml or if androgen deprivation was administered. Time to event was calculated from RP completion (neoadjuvant patients) or start of adjuvant/salvage RT. Statistical analysis by using two-sided student’s t-test and chi-square using JMP 9.0. Results: Median follow-up is 24 months, with a minimum follow-up of 8 months for neoadjuvant patients. No intra-operative morbidity was seen. Length of procedure was unchanged compared to the matched cohort (3.8 vs 3.8 h, p = 0.24); length of stay was slightly shorter for patients receiving neoadjuvant RT (median 1.9 vs 2.0 days, p = 0.02). Chronic urinary grade 2+ toxicities (CTCAE 2.0) occurred in 33% of neoadjuvant patients; one patient developed a symptomatic urethral stricture. 2 year actuarial BRFS was 66% for neoadjuvant patients and 67% for patients receiving adjuvant/salvage RT (p = 0.61). Conclusions: Multidisciplinary treatment including neoadjuvant RT followed by RP for high risk prostate cancer is safe and offers competitive biochemical control compared to a matched population undergoing post-operative RT. Evaluation of neoadjuvant radiotherapy in a phase II setting should be considered. Author Disclosure: B.F. Koontz: None. W.R. Lee: None. Z. Vujaskovic: None. M. Carroll: None. B.P. Quaranta: None. M.S. Anscher: None. C.N. Robertson: None. T.J. Polascik: None. J.W. Moul: None.
2392
Do Diabetic Patients Experience More Toxicity After External Beam Radiation Therapy For Prostate Cancer?
K. Kalakota1, D. Correa2, S. Liauw2 1
Northwestern University, Chicago, IL, 2University of Chicago, Chicago, IL
Purpose/Objective(s): To investigate the influence of diabetes mellitus (DM) on late genitourinary (GU) and gastrointestinal (GI) toxicity in patients treated with external beam radiation therapy (EBRT) for prostate cancer. Materials/Methods: 626 men were treated with curative-intent radiation therapy (RT) for prostate cancer between 1988 and 2008, and had a complete record of past medical history at the time of consultation. No patients had prostatectomy or brachytherapy. Median age was 69. By NCCN risk category, patients were classified as low (30%), intermediate (42%), or high-risk (29%). Median RT dose was 74 Gy. 52% were treated with Intensity-Modulated RT (IMRT), and 45% received androgen deprivation therapy (ADT) for a median 4 mo. 11% of patients had prior transurethral resection of the prostate (TURP). Late GU and GI RTOG toxicity was recorded at each follow-up 3 months after RT. Median follow-up was 57 mos. Results: 103 patients had DM at consultation (16%), which was either controlled by diet (8%), oral medications (52%), or insulin (39%). There were no differences between DM and non-DM patients with regard to age, PSA, risk classification, or TURP;
S397