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Undertreatment of Elderly Men With High-Risk Prostate Cancer
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Volume 99 Number 2S Supplement 2017 R. Haloi,2 V.J. Lowe,3 L.A. Mynderse,2 T.J. Welch,3 F.J. Quevedo,4 R.J. Karnes,2 T.M. Pisansky,1 and E.D. Kwon2; 1Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 2Department of Urology, Mayo Clinic, Rochester, MN, 3Department of Radiology, Mayo Clinic, Rochester, MN, 4Department of Medical Oncology, Mayo Clinic, Rochester, MN Purpose/Objective(s): Assess adverse effects (AEs) of 11C-choline PET/ CT (CholPET)-guided salvage pelvic and/or para-aortic (PA) nodal radiotherapy (RT) in prostate cancer (PCa) patients (pts) after radical prostatectomy. Materials/Methods: From 2013 to 2016, 106 pts received salvage pelvic and/or PA RT with CholPET-guided simultaneous integrated boost (SIB) to choline-avid sites. All patients had rising PSA following radical prostatectomy +/- prostate fossa (PF) RT with known recurrence limited to lymph nodes (LN) without bone or visceral metastases. Elective pelvic and/or PA LNs were treated with intensity-modulation to 45 Gy in 25 fractions with CholPET-guided SIB of 50-55 Gy (23%), 55-60 Gy (69%) or 60-62.5 Gy (8%). The PF was included in 26% as a separate sequential boost (median dose 68 Gy). Elective expansions included approximately 2 cm superior to choline-avid disease for PA recurrences. The superior extent of the RT field was at the vertebral body or on the superior disc space of S1 (11%), L5 (25%), L4 (17%), L3 (17%), L2 (21%), and L1 (7%). Androgen deprivation therapy was given neoadjuvantly 2-4 months (mos) prior and concurrently with RT, and up to 14 mos thereafter. Dose constraints included small bowel Dmax < 52 Gy, V50 < 2 cc, V45 < 150 cc, V30 < 300 cc, individual kidney V18 < 10%, and mean < 18 Gy. Pts were assessed by their provider with CTCAE v4 at baseline, post-RT, and at earlier (w 4 mos) and late (>10 mos) follow-up as part of their clinical care. Matched pair t-test was used to compare AEs at follow-up relative to baseline. Results: Median follow-up was 20 mos (range: 4-45 mos). Twenty-three pts (21%) received docetaxel-based chemotherapy after CholPET and before RT. Median PSA at time of positive CholPET was 2.3 ng/mL (IQR 1.4, 4.8). Median number of choline-avid LNs/pt was 2 (range 1-10), with pathologic confirmation in 47% of pts. Choline-avid recurrences were identified within the pelvis alone (54%), pelvis + PA (39%), or PA LN alone (7%). Mean (IQR) small bowel dosimetric parameters included Dmax 50.6 Gy (48.7, 52.4); V50: 4 cc (0, 1); V45: 33 cc (11, 44); and V30: 206 cc (109, 272). Baseline GI-toxicity included grade 0 (91%), grade 1 (7%) and grade 2 (2%). Post-RT gastrointestinal (GI) AEs included grade 0 (48%), grade 1 (49%) and grade 2 (3%), with a significant median increase of 1 grade above baseline (p<0.0001). Most pts had resolution of GI AEs by earlier (88% grade 0) and late (91% grade 0) follow-up, with no differences in mean AEs relative to baseline, pZ0.64 and pZ0.66, respectively. Conclusion: Salvage pelvic and/or PA nodal RT with CholPET-guided SIB appears to have a low short-term prevalence of GI AEs. The results of this non-controlled observational series should be validated in a prospective trial design that also seeks to clarify the efficacy of this salvage strategy. Author Disclosure: K.R. Jethwa: None. B.J. Davis: Consultant; Prospect Medical Inc., UpToDate Inc. Advisory Board; Prospect Medical Inc. Stock; Pfizer; American Board of Radiology, American College of Radiology. C.D. Hellekson: None. J.D. Evans: None. T.J. Wilhite: None. T.J. Whitaker: None. S.S. Park: None. C. Choo: None. B.J. Stish: None. K. Olivier: Stock; ViewRay Incorporated. R. Haloi: None. V.J. Lowe: Research Grant; GE Health Care, AVID Radiopharmaceuticals. Stock; Celgene, Alexion. L.A. Mynderse: Study Investigator; Philips Health Care, Inc. T.J. Welch: None. F.J. Quevedo: None. R.J. Karnes: None. T.M. Pisansky: None. E.D. Kwon: None.
2582 Undertreatment of Elderly Men With High-Risk Prostate Cancer S.B. Johnson,1 N.H. Lester-Coll,1 T.J. Bledsoe,1 J.R. Kelly,2 J.M. Stahl,1 S.K. Nath,1 and J.B. Yu2; 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): Treatment of high risk prostate cancer (PCa) with androgen deprivation therapy (ADT) alone is inferior to radiation therapy (RT) plus ADT. Elderly men with high-risk PCa are often undertreated. To assess for an age-dependent bias, we examined patterns of care and compared overall survival (OS) between men treated with ADT or RT+ADT. Materials/Methods: We queried the National Cancer Database between 2004-2013 and identified men 75 years of age with clinically localized high-risk PCa (Gleason 8-10, prostate specific antigen [PSA] >20 to 40 ng/ ml, or T3a) treated with ADT alone or ADT+RT. Univariate (UVA), multivariate (MVA) and subset OS analyses were completed using chisquared test, logistic regression, log-rank, Kaplan-Meier methods and coxproportional hazards models. Propensity score matching was completed using significant variables from logistic regression. Results: Among 17,636 patients treated with ADT, 14,254 (81%) were treated with RT and 3,382 (19%) with ADT alone. Median follow up was 71 months. Between 2004-2013, the proportion of men 75 treated with ADT alone remained unchanged (21% in 2004 and 20% in 2013). Factors independently associated with increased use of ADT alone were older age, African American race (vs. caucasian), uninsured and Medicaid insurance type (vs. Medicare), treatment in the South, Midwest and West (vs. Northeast), academic facility type (vs. non-academic), Charlson-Deyo comorbidity score (CCS) 1 and 2 (vs. 0), Gleason score 6 (vs. 7 and 8-10), and PSA of 10-20 and >20 (vs. <10). On UVA, ADT alone was associated with increased risk of death (hazard ratio [HR]: 2.5, 95% confidence interval [CI]: 2.4-2.7, p<0.001) when compared to RT+ADT. Five year OS for ADT alone and RT+ADT were 51% vs 78%, respectively (p<0.0001). On MVA, after controlling for age, race, insurance type, treatment location, facility type, CCS, PSA and clinical T-stage, ADT alone remained independently associated with increased risk of death (HR: 1.9, 95%CI: 1.7-2.0, p<0.001). Propensity score matching identified 4,216 patients and confirmed an increased risk of death associated with ADT alone (HR: 1.8, 95%CI: 1.7-2.0, p<0.001). On subset analysis, the increased risk of death associated with ADT alone persisted when stratified by CCS and age group (75-79, 80-84 and 85 years or greater) when compared to RT+ADT, except for those 85 years and older with CCS of 2 or greater. Conclusion: Despite randomized evidence to support the use of RT+ADT for men with high-risk PCa, approximately 1 in 5 men who are 75 years and older are treated with ADT alone. This approach is associated with a 2fold risk of death when compared to RT+ADT in most men. Careful consideration of life expectancy and comorbidity status should be given before omitting RT in the elderly. Author Disclosure: S.B. Johnson: None. N.H. Lester-Coll: Honoraria; Elekta AB. T.J. Bledsoe: None. J.R. Kelly: None. J.M. Stahl: None. S.K. Nath: None. J.B. Yu: None.
2583 Multimodality Image Registrations for Combined MRI/CT HDR Prostate Brachytherapy: The Concept of the Iurethra M. Jolicoeur, T. Derashodian, J. Last, G. Wakil, and M. Mondat; Hopital Charles-LeMoyne, Longueuil, QC, Canada Purpose/Objective(s): To assess and compare the accepted surrogate urethra and the true urethra (iUrethra) in prostate HDR brachytherapy dosimetry. Materials/Methods: 40 consecutive prostate cancer patients treated with HDR brachytherapy as a boost constituted the study group. All patients had an ultrasound guided implant.A foley catheter was installed at the time of implantation. Dosimetry was done using fusion between a post implant CT scan and an T2 MRI. The surrogate urethra was defined by contouring the foley on the CT-scan and the true urethra (iUrethra) was contoured on the MRI images. The true and surrogate volumes were measured and compared as well as the median and maximum dose received by each of the structures. Results: The characteristics of the implants were as follows: median D(90) was 113%, median V(100) was 97.9%, and median V(150) was 37%. The
Volume 99 Number 2S Supplement 2017 R. Haloi,2 V.J. Lowe,3 L.A. Mynderse,2 T.J. Welch,3 F.J. Quevedo,4 R.J. Karnes,2 T.M. Pisansky,1 and E.D. Kwon2; 1Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 2Department of Urology, Mayo Clinic, Rochester, MN, 3Department of Radiology, Mayo Clinic, Rochester, MN, 4Department of Medical Oncology, Mayo Clinic, Rochester, MN Purpose/Objective(s): Assess adverse effects (AEs) of 11C-choline PET/ CT (CholPET)-guided salvage pelvic and/or para-aortic (PA) nodal radiotherapy (RT) in prostate cancer (PCa) patients (pts) after radical prostatectomy. Materials/Methods: From 2013 to 2016, 106 pts received salvage pelvic and/or PA RT with CholPET-guided simultaneous integrated boost (SIB) to choline-avid sites. All patients had rising PSA following radical prostatectomy +/- prostate fossa (PF) RT with known recurrence limited to lymph nodes (LN) without bone or visceral metastases. Elective pelvic and/or PA LNs were treated with intensity-modulation to 45 Gy in 25 fractions with CholPET-guided SIB of 50-55 Gy (23%), 55-60 Gy (69%) or 60-62.5 Gy (8%). The PF was included in 26% as a separate sequential boost (median dose 68 Gy). Elective expansions included approximately 2 cm superior to choline-avid disease for PA recurrences. The superior extent of the RT field was at the vertebral body or on the superior disc space of S1 (11%), L5 (25%), L4 (17%), L3 (17%), L2 (21%), and L1 (7%). Androgen deprivation therapy was given neoadjuvantly 2-4 months (mos) prior and concurrently with RT, and up to 14 mos thereafter. Dose constraints included small bowel Dmax < 52 Gy, V50 < 2 cc, V45 < 150 cc, V30 < 300 cc, individual kidney V18 < 10%, and mean < 18 Gy. Pts were assessed by their provider with CTCAE v4 at baseline, post-RT, and at earlier (w 4 mos) and late (>10 mos) follow-up as part of their clinical care. Matched pair t-test was used to compare AEs at follow-up relative to baseline. Results: Median follow-up was 20 mos (range: 4-45 mos). Twenty-three pts (21%) received docetaxel-based chemotherapy after CholPET and before RT. Median PSA at time of positive CholPET was 2.3 ng/mL (IQR 1.4, 4.8). Median number of choline-avid LNs/pt was 2 (range 1-10), with pathologic confirmation in 47% of pts. Choline-avid recurrences were identified within the pelvis alone (54%), pelvis + PA (39%), or PA LN alone (7%). Mean (IQR) small bowel dosimetric parameters included Dmax 50.6 Gy (48.7, 52.4); V50: 4 cc (0, 1); V45: 33 cc (11, 44); and V30: 206 cc (109, 272). Baseline GI-toxicity included grade 0 (91%), grade 1 (7%) and grade 2 (2%). Post-RT gastrointestinal (GI) AEs included grade 0 (48%), grade 1 (49%) and grade 2 (3%), with a significant median increase of 1 grade above baseline (p<0.0001). Most pts had resolution of GI AEs by earlier (88% grade 0) and late (91% grade 0) follow-up, with no differences in mean AEs relative to baseline, pZ0.64 and pZ0.66, respectively. Conclusion: Salvage pelvic and/or PA nodal RT with CholPET-guided SIB appears to have a low short-term prevalence of GI AEs. The results of this non-controlled observational series should be validated in a prospective trial design that also seeks to clarify the efficacy of this salvage strategy. Author Disclosure: K.R. Jethwa: None. B.J. Davis: Consultant; Prospect Medical Inc., UpToDate Inc. Advisory Board; Prospect Medical Inc. Stock; Pfizer; American Board of Radiology, American College of Radiology. C.D. Hellekson: None. J.D. Evans: None. T.J. Wilhite: None. T.J. Whitaker: None. S.S. Park: None. C. Choo: None. B.J. Stish: None. K. Olivier: Stock; ViewRay Incorporated. R. Haloi: None. V.J. Lowe: Research Grant; GE Health Care, AVID Radiopharmaceuticals. Stock; Celgene, Alexion. L.A. Mynderse: Study Investigator; Philips Health Care, Inc. T.J. Welch: None. F.J. Quevedo: None. R.J. Karnes: None. T.M. Pisansky: None. E.D. Kwon: None.
2582 Undertreatment of Elderly Men With High-Risk Prostate Cancer S.B. Johnson,1 N.H. Lester-Coll,1 T.J. Bledsoe,1 J.R. Kelly,2 J.M. Stahl,1 S.K. Nath,1 and J.B. Yu2; 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): Treatment of high risk prostate cancer (PCa) with androgen deprivation therapy (ADT) alone is inferior to radiation therapy (RT) plus ADT. Elderly men with high-risk PCa are often undertreated. To assess for an age-dependent bias, we examined patterns of care and compared overall survival (OS) between men treated with ADT or RT+ADT. Materials/Methods: We queried the National Cancer Database between 2004-2013 and identified men 75 years of age with clinically localized high-risk PCa (Gleason 8-10, prostate specific antigen [PSA] >20 to 40 ng/ ml, or T3a) treated with ADT alone or ADT+RT. Univariate (UVA), multivariate (MVA) and subset OS analyses were completed using chisquared test, logistic regression, log-rank, Kaplan-Meier methods and coxproportional hazards models. Propensity score matching was completed using significant variables from logistic regression. Results: Among 17,636 patients treated with ADT, 14,254 (81%) were treated with RT and 3,382 (19%) with ADT alone. Median follow up was 71 months. Between 2004-2013, the proportion of men 75 treated with ADT alone remained unchanged (21% in 2004 and 20% in 2013). Factors independently associated with increased use of ADT alone were older age, African American race (vs. caucasian), uninsured and Medicaid insurance type (vs. Medicare), treatment in the South, Midwest and West (vs. Northeast), academic facility type (vs. non-academic), Charlson-Deyo comorbidity score (CCS) 1 and 2 (vs. 0), Gleason score 6 (vs. 7 and 8-10), and PSA of 10-20 and >20 (vs. <10). On UVA, ADT alone was associated with increased risk of death (hazard ratio [HR]: 2.5, 95% confidence interval [CI]: 2.4-2.7, p<0.001) when compared to RT+ADT. Five year OS for ADT alone and RT+ADT were 51% vs 78%, respectively (p<0.0001). On MVA, after controlling for age, race, insurance type, treatment location, facility type, CCS, PSA and clinical T-stage, ADT alone remained independently associated with increased risk of death (HR: 1.9, 95%CI: 1.7-2.0, p<0.001). Propensity score matching identified 4,216 patients and confirmed an increased risk of death associated with ADT alone (HR: 1.8, 95%CI: 1.7-2.0, p<0.001). On subset analysis, the increased risk of death associated with ADT alone persisted when stratified by CCS and age group (75-79, 80-84 and 85 years or greater) when compared to RT+ADT, except for those 85 years and older with CCS of 2 or greater. Conclusion: Despite randomized evidence to support the use of RT+ADT for men with high-risk PCa, approximately 1 in 5 men who are 75 years and older are treated with ADT alone. This approach is associated with a 2fold risk of death when compared to RT+ADT in most men. Careful consideration of life expectancy and comorbidity status should be given before omitting RT in the elderly. Author Disclosure: S.B. Johnson: None. N.H. Lester-Coll: Honoraria; Elekta AB. T.J. Bledsoe: None. J.R. Kelly: None. J.M. Stahl: None. S.K. Nath: None. J.B. Yu: None.
2583 Multimodality Image Registrations for Combined MRI/CT HDR Prostate Brachytherapy: The Concept of the Iurethra M. Jolicoeur, T. Derashodian, J. Last, G. Wakil, and M. Mondat; Hopital Charles-LeMoyne, Longueuil, QC, Canada Purpose/Objective(s): To assess and compare the accepted surrogate urethra and the true urethra (iUrethra) in prostate HDR brachytherapy dosimetry. Materials/Methods: 40 consecutive prostate cancer patients treated with HDR brachytherapy as a boost constituted the study group. All patients had an ultrasound guided implant.A foley catheter was installed at the time of implantation. Dosimetry was done using fusion between a post implant CT scan and an T2 MRI. The surrogate urethra was defined by contouring the foley on the CT-scan and the true urethra (iUrethra) was contoured on the MRI images. The true and surrogate volumes were measured and compared as well as the median and maximum dose received by each of the structures. Results: The characteristics of the implants were as follows: median D(90) was 113%, median V(100) was 97.9%, and median V(150) was 37%. The