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Toxicity and Biochemical Outcomes of Hypofractionated Intensity Modulated Post-Operative Radiation Therapy for Prostate Cancer
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Volume 99 Number 2S Supplement 2017 Author Disclosure: A. Sundaramurthy: None. V.C. Kong: None. J. Helou: None. T. Rosewall: None. T. Craig: Honoraria; Modus Medical devices. R.G. Bristow: None. A. Berlin: None. P. Chung: Research Grant; Sanofi.
2637 Toxicity of IMRT for prostate cancer following transurethral resection of the prostate S. Takemoto,1 Y. Shibamoto,2 A. Miyakawa,3 S. Otsuka,4 H. Iwata,5,6 K. Kosaki,7 M. Ueno,8 and T. Hirai9; 1Department of Radiology, Fujieda Heisei Memorial Hospital, Fujieda, Japan, 2 Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 3Department of Radiation Oncology, Nanbu Tokushukai Hospital, Okinawa, Japan, 4Department of Radiology, Okazaki City Hospital, Okazaki, Japan, 5Nagoya Proton Therapy Center, Nagoya, Japan, 6Department of Proton Therapy, Nagoya Proton Therapy Center, Nagoya, Japan, 7Department of Radiology, Kasugai Municipal Hospital, Kasugai, Japan, 8Department of Urology, Fujieda Heisei Memorial Hospital, Fujieda, Japan, 9Stereotaxis and Gamma Unit Center, Fujieda Heisei Memorial Hospital, Fujieda, Japan Purpose/Objective(s): To evaluate toxicity of IMRT for localized prostate cancer in patients with a history of transurethral resection (TURP). Materials/Methods: Between June 2010 and October 2015, 174 patients were treated with a 5-field IMRT technique at Fujieda Heisei Memorial Hospital. Seventy-three (42%) patients had a history of TURP and they were compared with 101 patients treated without prior TURP. The median age was 71 years (range, 59-85) in the TURP group and 70 years (52-88) in the non-TURP group. Patients in the TURP and non-TURP groups were classified into lowrisk (n Z 11, 2), intermediate-risk (n Z 26, 30), and high-risk groups (n Z 36, 67) (p < 0.01) according to the 7th edition of TNM staging and D’Amico risk classification at initial diagnosis. Androgen deprivation therapy was given according to patient risk (96% of all patients). Twenty-one (12%) patients had diabetes mellitus and 21 (12%) were taking anticoagulants. We assessed International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS). The median time from TURP to IMRT was 4 months (range, 3-22). There were significant changes after TURP in the mean maximum urinary flow rate (12.7 to 18.7 ml/s, p < 0.01) and IPSS (10.7 to 5.7, p < 0.01). The mean OABSS showed no significant changes (3.8 to 3.7). Patients were treated with a daily fraction of 2.0 Gy to a total of 74 Gy (low risk) or 78 Gy (intermediate or high risk). Toxicities were evaluated with the Common Terminology Criteria for Adverse Events version 4.0. Results: The median follow-up for the TURP and non-TURP groups were 40 (range, 8-73) and 37 months (10-73), respectively (pZ0.54). Three patients (4%) with TURP and 1 (1%) patient without TURP had developed Grade 2 genitourinary (GU) toxicity before the start of IMRT. There was no significant difference in the incidence of acute Grade 2 GU toxicity (17% vs. 15%, p Z 0.68). Two (3%) patients with TURP had actue Grade 2 gastrointestinal (GI) toxicity. Patients with TURP had higher cumulative incidence of Grade 2 GU toxicity at 3 years (49% vs. 18%, p < 0.01). Three patients (4%) with TURP and 3 (3%) without TURP had late Grade 2 GI toxicity. Presence of diabetes mellitus and use of anticoagulants were not correlated with the cumulative incidence of Grade 2 GU toxicity in both of the TURP and nonTURP groups. The mean IPSS at 0 and 24 months were 6.6 5.5 (SD) and 5.9 6.5, respectively, in the TURP group, and 6.1 4.6 and 4.3 3.1, respectively, in the non-TURP group. The non-TURP group had a significant decline in the mean IPSS (p < 0.01). The mean OABSS changed from 4.0 2.6 to 3.6 2.8 and from 3.2 2.3 to 2.9 1.8, respectively. Conclusion: Patients treated with IMRT following TURP had a higher risk of late GU toxicity. Author Disclosure: S. Takemoto: None. Y. Shibamoto: None. A. Miyakawa: None. S. Otsuka: None. H. Iwata: None. K. Kosaki: None. M. Ueno: None. T. Hirai: None.
2638 Toxicity and Biochemical Outcomes of Hypofractionated Intensity Modulated PostOperative Radiation Therapy for Prostate Cancer D.J. Tandberg,1 W.R. Lee,1 J.K. Salama,2 and B.F. Koontz3; 1Duke University School of Medicine, Durham, NC, 2Duke University Medical Center, Durham, NC, 3Duke Cancer Institute, Durham, NC Purpose/Objective(s): Moderately hypofractionated radiation therapy (RT) for intact prostate cancer has been shown in multiple randomized studies to be non-inferior to conventionally fractionated RT. In the postprostatectomy setting the role of hypofractionated RT is less clear. Therefore we report biochemical control, acute and late toxicity in a large series of patients treated with post-prostatectomy hypofractionated RT. Materials/Methods: Consecutive pN0/Nx patients treated with hypofractionated (2.5 Gy per fraction) intensity modulated adjuvant or salvage RT to the prostate bed from 2008 and 2016 comprised the study cohort. Androgen deprivation therapy (ADT) was given at the discretion of the radiation oncologist. Acute toxicities were graded per CTCAE V4.0. Late toxicity was graded using the RTOG/EORTC scale. Biochemical progression after RT was defined as a persistent PSAvalue > 0.2 ng/ml above the post-RT nadir or an increase in PSA despite RT. Biochemical progression free survival (bPFS) and actuarial grade 2+ GU and GI toxicity rates were calculated using the Kaplan-Meier methods. Results: 167 patients with a 38 month (range, 1-94 months) median follow-up were evaluated. Median age was 64 yrs (range, 41-79 yrs). 51% had pT3a/pT3b disease; 60% had positive surgical margins. Median pre-RT PSAwas 0.24 ng/ml (range, 0-13.66 ng/ml). The total radiation dose was 65 Gy (range, 57.5-70 Gy) in 87% of cases. Neoadjuvant and concurrent ADTwas given to 54 patients (35%). The crude incidence of acute grade 2+ GU toxicity and GI toxicity was 22% and 5%, respectively. One acute grade 3 GU and no acute grade 3 GI toxicity occurred. 44 patients had late grade 2 GU toxicity, 10 grade 3, and 1 grade 4. All cases of grade 3 toxicity were secondary to frequent gross hematuria. The 3-year rate of late grade 2+ GU toxicity was 38% (95% confidence interval [CI], 2946%). All but one late grade 3 GU toxicity resolved at last follow-up. Thirteen patients had late grade 2 GI toxicity, 0 grade 3, and 1 grade 4. The 3-year late grade 2+ GI toxicity rate was 11% (range, 5.5-16.5%). In all 167 patients 3 year actuarial bDFS was 81% (95% CI, 74-88%). For the first 100 consecutive patients treated (median follow-up 57 months, range 8-94 months) 5 year actuarial bDFS was 78% (95% CI, 69-86%). In total 6 patients died during the study period, 2 from prostate cancer. Conclusion: Hypofractionated intensity modulated RT at 2.5 Gy per fraction for post-operative prostate cancer treatment shows promising early biochemical control. The incidence of late grade 2+ GU toxicity, mainly consisting of macroscopic hematuria, was higher than expected but in most cases transient. Further research comparing the results of this hypofractionated cohort to a contemporary cohort treated with conventionally fractionated post-prostatectomy RT is ongoing and will be presented at the meeting. Author Disclosure: D.J. Tandberg: None. W. Lee: Independent Contractor; ASTRO. Royalties; UpToDate. J.K. Salama: Employee; Duke University School of Medicine. Research Grant; BMS, Celldex, GSK, Immunocore, Merck, AbbVie; ARS-ACR. B.F. Koontz: Employee; Duke University Medical Center. Research Grant; Janssen Services LLC. Advisory Board; Blue Earth Diagnostics. Travel Expenses; ASTRO. Royalty; UpToDate; ASTRO, IHE-RO.
2639 Quality of Reporting of Radiation Therapy in Randomized Controlled Trials in Prostate Cancer J. Tey,1 H. Zheng,2 T.H. Tan,1 and Y.Y. Soon3; 1National University Cancer Institute, Singapore, Singapore, Singapore, 2National Registry of diseases, Health Promotion Board, Singapore, Singapore, 3National University Cancer Institute (Singapore), Singapore, Singapore
Volume 99 Number 2S Supplement 2017 Author Disclosure: A. Sundaramurthy: None. V.C. Kong: None. J. Helou: None. T. Rosewall: None. T. Craig: Honoraria; Modus Medical devices. R.G. Bristow: None. A. Berlin: None. P. Chung: Research Grant; Sanofi.
2637 Toxicity of IMRT for prostate cancer following transurethral resection of the prostate S. Takemoto,1 Y. Shibamoto,2 A. Miyakawa,3 S. Otsuka,4 H. Iwata,5,6 K. Kosaki,7 M. Ueno,8 and T. Hirai9; 1Department of Radiology, Fujieda Heisei Memorial Hospital, Fujieda, Japan, 2 Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 3Department of Radiation Oncology, Nanbu Tokushukai Hospital, Okinawa, Japan, 4Department of Radiology, Okazaki City Hospital, Okazaki, Japan, 5Nagoya Proton Therapy Center, Nagoya, Japan, 6Department of Proton Therapy, Nagoya Proton Therapy Center, Nagoya, Japan, 7Department of Radiology, Kasugai Municipal Hospital, Kasugai, Japan, 8Department of Urology, Fujieda Heisei Memorial Hospital, Fujieda, Japan, 9Stereotaxis and Gamma Unit Center, Fujieda Heisei Memorial Hospital, Fujieda, Japan Purpose/Objective(s): To evaluate toxicity of IMRT for localized prostate cancer in patients with a history of transurethral resection (TURP). Materials/Methods: Between June 2010 and October 2015, 174 patients were treated with a 5-field IMRT technique at Fujieda Heisei Memorial Hospital. Seventy-three (42%) patients had a history of TURP and they were compared with 101 patients treated without prior TURP. The median age was 71 years (range, 59-85) in the TURP group and 70 years (52-88) in the non-TURP group. Patients in the TURP and non-TURP groups were classified into lowrisk (n Z 11, 2), intermediate-risk (n Z 26, 30), and high-risk groups (n Z 36, 67) (p < 0.01) according to the 7th edition of TNM staging and D’Amico risk classification at initial diagnosis. Androgen deprivation therapy was given according to patient risk (96% of all patients). Twenty-one (12%) patients had diabetes mellitus and 21 (12%) were taking anticoagulants. We assessed International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS). The median time from TURP to IMRT was 4 months (range, 3-22). There were significant changes after TURP in the mean maximum urinary flow rate (12.7 to 18.7 ml/s, p < 0.01) and IPSS (10.7 to 5.7, p < 0.01). The mean OABSS showed no significant changes (3.8 to 3.7). Patients were treated with a daily fraction of 2.0 Gy to a total of 74 Gy (low risk) or 78 Gy (intermediate or high risk). Toxicities were evaluated with the Common Terminology Criteria for Adverse Events version 4.0. Results: The median follow-up for the TURP and non-TURP groups were 40 (range, 8-73) and 37 months (10-73), respectively (pZ0.54). Three patients (4%) with TURP and 1 (1%) patient without TURP had developed Grade 2 genitourinary (GU) toxicity before the start of IMRT. There was no significant difference in the incidence of acute Grade 2 GU toxicity (17% vs. 15%, p Z 0.68). Two (3%) patients with TURP had actue Grade 2 gastrointestinal (GI) toxicity. Patients with TURP had higher cumulative incidence of Grade 2 GU toxicity at 3 years (49% vs. 18%, p < 0.01). Three patients (4%) with TURP and 3 (3%) without TURP had late Grade 2 GI toxicity. Presence of diabetes mellitus and use of anticoagulants were not correlated with the cumulative incidence of Grade 2 GU toxicity in both of the TURP and nonTURP groups. The mean IPSS at 0 and 24 months were 6.6 5.5 (SD) and 5.9 6.5, respectively, in the TURP group, and 6.1 4.6 and 4.3 3.1, respectively, in the non-TURP group. The non-TURP group had a significant decline in the mean IPSS (p < 0.01). The mean OABSS changed from 4.0 2.6 to 3.6 2.8 and from 3.2 2.3 to 2.9 1.8, respectively. Conclusion: Patients treated with IMRT following TURP had a higher risk of late GU toxicity. Author Disclosure: S. Takemoto: None. Y. Shibamoto: None. A. Miyakawa: None. S. Otsuka: None. H. Iwata: None. K. Kosaki: None. M. Ueno: None. T. Hirai: None.
2638 Toxicity and Biochemical Outcomes of Hypofractionated Intensity Modulated PostOperative Radiation Therapy for Prostate Cancer D.J. Tandberg,1 W.R. Lee,1 J.K. Salama,2 and B.F. Koontz3; 1Duke University School of Medicine, Durham, NC, 2Duke University Medical Center, Durham, NC, 3Duke Cancer Institute, Durham, NC Purpose/Objective(s): Moderately hypofractionated radiation therapy (RT) for intact prostate cancer has been shown in multiple randomized studies to be non-inferior to conventionally fractionated RT. In the postprostatectomy setting the role of hypofractionated RT is less clear. Therefore we report biochemical control, acute and late toxicity in a large series of patients treated with post-prostatectomy hypofractionated RT. Materials/Methods: Consecutive pN0/Nx patients treated with hypofractionated (2.5 Gy per fraction) intensity modulated adjuvant or salvage RT to the prostate bed from 2008 and 2016 comprised the study cohort. Androgen deprivation therapy (ADT) was given at the discretion of the radiation oncologist. Acute toxicities were graded per CTCAE V4.0. Late toxicity was graded using the RTOG/EORTC scale. Biochemical progression after RT was defined as a persistent PSAvalue > 0.2 ng/ml above the post-RT nadir or an increase in PSA despite RT. Biochemical progression free survival (bPFS) and actuarial grade 2+ GU and GI toxicity rates were calculated using the Kaplan-Meier methods. Results: 167 patients with a 38 month (range, 1-94 months) median follow-up were evaluated. Median age was 64 yrs (range, 41-79 yrs). 51% had pT3a/pT3b disease; 60% had positive surgical margins. Median pre-RT PSAwas 0.24 ng/ml (range, 0-13.66 ng/ml). The total radiation dose was 65 Gy (range, 57.5-70 Gy) in 87% of cases. Neoadjuvant and concurrent ADTwas given to 54 patients (35%). The crude incidence of acute grade 2+ GU toxicity and GI toxicity was 22% and 5%, respectively. One acute grade 3 GU and no acute grade 3 GI toxicity occurred. 44 patients had late grade 2 GU toxicity, 10 grade 3, and 1 grade 4. All cases of grade 3 toxicity were secondary to frequent gross hematuria. The 3-year rate of late grade 2+ GU toxicity was 38% (95% confidence interval [CI], 2946%). All but one late grade 3 GU toxicity resolved at last follow-up. Thirteen patients had late grade 2 GI toxicity, 0 grade 3, and 1 grade 4. The 3-year late grade 2+ GI toxicity rate was 11% (range, 5.5-16.5%). In all 167 patients 3 year actuarial bDFS was 81% (95% CI, 74-88%). For the first 100 consecutive patients treated (median follow-up 57 months, range 8-94 months) 5 year actuarial bDFS was 78% (95% CI, 69-86%). In total 6 patients died during the study period, 2 from prostate cancer. Conclusion: Hypofractionated intensity modulated RT at 2.5 Gy per fraction for post-operative prostate cancer treatment shows promising early biochemical control. The incidence of late grade 2+ GU toxicity, mainly consisting of macroscopic hematuria, was higher than expected but in most cases transient. Further research comparing the results of this hypofractionated cohort to a contemporary cohort treated with conventionally fractionated post-prostatectomy RT is ongoing and will be presented at the meeting. Author Disclosure: D.J. Tandberg: None. W. Lee: Independent Contractor; ASTRO. Royalties; UpToDate. J.K. Salama: Employee; Duke University School of Medicine. Research Grant; BMS, Celldex, GSK, Immunocore, Merck, AbbVie; ARS-ACR. B.F. Koontz: Employee; Duke University Medical Center. Research Grant; Janssen Services LLC. Advisory Board; Blue Earth Diagnostics. Travel Expenses; ASTRO. Royalty; UpToDate; ASTRO, IHE-RO.
2639 Quality of Reporting of Radiation Therapy in Randomized Controlled Trials in Prostate Cancer J. Tey,1 H. Zheng,2 T.H. Tan,1 and Y.Y. Soon3; 1National University Cancer Institute, Singapore, Singapore, Singapore, 2National Registry of diseases, Health Promotion Board, Singapore, Singapore, 3National University Cancer Institute (Singapore), Singapore, Singapore