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Are Results From Intermediate-Risk Prostate Cancer Patients Treated Within Clinical Trials Applicable to Real Life?
Poster Viewing Session E243
Volume 93 Number 3S Supplement 2015 and the median time to nadir was 39 months (2 to 89 months). The 5-year bPFS rate was 95.4%. The 5-year distant metastasis-free, cause-specific, and overall survival rates were 98.9%, 99.6%, and 95.3%, respectively. On multivariate analysis, the number of intermediate-risk factors (1 vs multiple) significantly predicted biochemical recurrence (hazard ratio [HR] 0.4, PZ.028) as patients with multiple risk factors had worse biochemical control. The use of ADT did not significantly improve biochemical control at 5 years (HR 1.8, PZ.325). A separate multivariate analysis was performed including only patients with 10 or more zones biopsied at the time of diagnosis. The number of intermediate-risk factors remained a predictor of biochemical relapse-free survival (HR 0.3, PZ.037). A primary Gleason score of 4 (4+3Z7) versus a primary Gleason score of 3 (3+3Z6 or 3+4Z7) also predicted worse biochemical control (HR 0.2, PZ0.028). Conclusion: PT provided excellent biochemical control for patients with intermediate-risk prostate cancer. Multiple intermediate-risk factors significantly increased the risk for biochemical failure. In patients with at least a 10-zone biopsy, a primary Gleason score of 4 also predicted worse biochemical relapse-free survival. Short-term ADT did not improve biochemical control, but selection bias likely mitigated its effects. Author Disclosure: C.M. Bryant: None. W.M. Mendenhall: None. B.S. Hoppe: None. R.H. Henderson: None. R. Nichols: None. Z. Su: None. C.R. Williams: None. C.G. Morris: None. Z. Li: None. N.P. Mendenhall: None.
2604 Focal Nodal SBRT or Elective Nodal Protracted Salvage Radiation Therapy for Prostate Cancer Patients With a Choline PET-CT Positive Nodal Relapse G. Crehange,1 P. Maingon,2 A. Cueff,2 G. Truc,3 K. Peignaux,4 F. Mazoyer,3 N. Vulquin,1 M. Quivrin,1 S. Naudy,1 and E. Martin1; 1Centre Georges-Francois Leclerc, Dijon Cedex, France, 2Centre Georges Franc¸ois Leclerc, Dijon, France, 3Centre Georges Franc¸ois Leclerc, Dijon, France, 4Centre GF Leclerc, Dijon, France Purpose/Objective(s): 18F or 11C choline positron emission tomographyecomputed tomography (PET-CT) has significantly improved the detection of occult nodal relapse in prostate cancer patients with a rising prostate-specific antigen (PSA) level after radical prostatectomy and/or external radiation therapy (RT). In parallel, focal hypofractionated stereotactic body RT (fSBRT) is an emerging salvage RT (sRT) for oligometastatic diseases. It allows delivery of a very high biologically effective dose (BED) in few fractions but to a small volume (e.g., involved node only). In this preliminary report, we aimed to assess short-term biochemical response of focal SBRT versus protracted ENI in node-positive recurrent prostate cancer on choline PET-CT. Materials/Methods: Between 2009 and 2014, 102 patients underwent choline PET-TDM in our center. Of these, 37 had sRT without hormones for nodal relapse only. Patients underwent either fSBRT (nZ28) or protracted elective nodal irradiation (nZ 9) combined with a protracted boost to positive nodes (pENI). Patients treated with fSBRT received 30 to 45 Gy in 3 to 6 fractions while patients treated with pENI had 60 to 66Gy in 25 to 33 fractions. Failure was defined as PSA rising higher than pre-sRT on 2 consecutive samples or the initiation of any second salvage therapy. PSA nadir (nPSA), time to nPSA, and time to failure (TTF) were assessed. Results: The characteristics of patients and tumor at time of relapse were similar. The median PSA values at the time of sRT were 5.9 ng/mL (1.3; 17.3) with fSBRT and 6.9 ng/mL (0.5; 13.8) with pENI (PZNS); The median follow-up was 1.95 years (95% CI: 0.54-1.52). Fifteen failures occurred with fSBRT (51.7%) and 4 failures with pENI (44.4%). The median PSA nadir at 2 years was 0.57 (0.01-4.52) with fSBRT and 0.02 (0.01-0.07) with pENI (PZ.0004). The time to nPSA at 2 years was 17.61 months (0.20-23.62) with fSBRT and 8.46 months (5.19-18.37) with pENI (PZ.05). The median TTF was 2.89 years (95% CI: 1.24-4.65) with fSBRT and 4.73 years (95% CI: 0.40-ND) with pENI (PZ NS). Conclusion: Patients with a nodal relapse on fluorocholine PET-CT who were treated with pENI experienced a lower nPSA and shorter time to nPSA 2 years following completion of sRT than with fSBRT, consistent
with the eradication of micrometastatic disease in PET-negative nodes. Whether this translates into improved biochemical control and/or a clinical relapse needs longer follow-up. Author Disclosure: G. Crehange: None. P. Maingon: None. A. Cueff: None. G. Truc: None. K. Peignaux: None. F. Mazoyer: None. N. Vulquin: None. M. Quivrin: None. S. Naudy: None. E. Martin: None.
2605 Are Results From Intermediate-Risk Prostate Cancer Patients Treated Within Clinical Trials Applicable to Real Life? D. Taussky,1 J.P. Bahary,2 C. Lambert,1 M.C. Beauchemin,2 G. Delouya,1 M. Barkati,3 and X. Liem4; 1Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada, 2Hopital Notre-Dame du CHUM, Montreal, QC, Canada, 3Centre Hospitalier de l’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 4Univesrite Montreal, Montreal, QC, Canada Purpose/Objective(s): There is some doubt on whether clinical studies (CSs) have selective inclusion criteria that might not represent real-life patients (RLPs) and may limit their applicability to daily clinical practice. Patients in CSs and RLPs might have different comorbidities which can have an impact on overall survival. We assessed whether patients from CSs differ from patients not included in terms of comorbidity, prostate cancer aggressiveness, and biochemical recurrence. Materials/Methods: We identified 468 patients with D’Amico intermediaterisk prostate cancer from our institutional database all treated with external beam radiation therapy only. Three hundred seven patients were treated in a CS, including 2, multinational randomized trials (PROFIT and RTOG 0126), each including >80 patients from our center; one in-house phase 2 with >40 patients and some smaller randomized studies with <13 patients each. These CS patients were compared to 161 patients (RLPs) who were not included in any CS. Patients treated in CSs were compared to the RLPs using nonparametric tests. Logistic regression was performed to explore predictive factors of CS inclusion. Biochemical recurrence rate was estimated using the Kaplan-Meier method and compared using the log-rank test. Results: Median follow-up was 56 months (interquartile range 36-78 months). There was no difference in age (mean 70 years for both, PZ.95) or in cancer aggressiveness between both groups: PSA >10 ng/mL in 28% of CS patients and in 32% of RLPs (PZ.37). Gleason score 4+3 was found in 29% of CS patients and in 30% of RLPs (PZ.58). CS patients had more frequently hypertension (60% CS vs 46% RLPs, PZ.01), and more often hypercholesterolemia (51% for CS vs 43% in RLPs, PZ.01). In univariate analysis, myocardial infarction (PZ.05) and hypertension (PZ.003) were predictive of CS inclusion. On multivariate analysis, only hypertension was a significant predictor (hazard ratio [HR] 0.6, 95% confidence interval [CI] 0.4-0.9, PZ.012). The Cancer of the Prostate Risk Assessment score showed a trend toward a higher score in patients not treated in a CS (HR 1.15, 95 %CI 0.98-1.32, PZ.09). Biochemical recurrence-free survival was similar between both groups with a 5-year rate of 94% in both groups (PZ.65). Conclusion: In our exploratory analysis, we found that patients treated in CSs did not differ from RLPs in terms of age, prostate cancer aggressiveness, or biochemical outcome. Patients with comorbidity were more often included in CSs. The impact on overall survival remains unclear. In our institution, conclusions from CS can be transferred to daily practice. Author Disclosure: D. Taussky: None. J. Bahary: None. C. Lambert: None. M. Beauchemin: None. G. Delouya: None. M. Barkati: None. X. Liem: None.
2606 Results of Scanning Beam Proton Therapy (SCBT) for the Treatment of Patients With High-Risk Prostate Cancer S. Choi,1 Q. Nguyen,1 T.J. Pugh,1 U. Mahmood,1 S.E. McGuire,2 K.E. Hoffman,1 S.J. Frank,1 D.A. Kuban,1 and A.K. Lee3; 1MD Anderson Cancer Center, Houston, TX, 2The University of Texas MD Anderson Cancer Center, Houston, TX, 3Texas Center for Proton Therapy, Irving, TX
Volume 93 Number 3S Supplement 2015 and the median time to nadir was 39 months (2 to 89 months). The 5-year bPFS rate was 95.4%. The 5-year distant metastasis-free, cause-specific, and overall survival rates were 98.9%, 99.6%, and 95.3%, respectively. On multivariate analysis, the number of intermediate-risk factors (1 vs multiple) significantly predicted biochemical recurrence (hazard ratio [HR] 0.4, PZ.028) as patients with multiple risk factors had worse biochemical control. The use of ADT did not significantly improve biochemical control at 5 years (HR 1.8, PZ.325). A separate multivariate analysis was performed including only patients with 10 or more zones biopsied at the time of diagnosis. The number of intermediate-risk factors remained a predictor of biochemical relapse-free survival (HR 0.3, PZ.037). A primary Gleason score of 4 (4+3Z7) versus a primary Gleason score of 3 (3+3Z6 or 3+4Z7) also predicted worse biochemical control (HR 0.2, PZ0.028). Conclusion: PT provided excellent biochemical control for patients with intermediate-risk prostate cancer. Multiple intermediate-risk factors significantly increased the risk for biochemical failure. In patients with at least a 10-zone biopsy, a primary Gleason score of 4 also predicted worse biochemical relapse-free survival. Short-term ADT did not improve biochemical control, but selection bias likely mitigated its effects. Author Disclosure: C.M. Bryant: None. W.M. Mendenhall: None. B.S. Hoppe: None. R.H. Henderson: None. R. Nichols: None. Z. Su: None. C.R. Williams: None. C.G. Morris: None. Z. Li: None. N.P. Mendenhall: None.
2604 Focal Nodal SBRT or Elective Nodal Protracted Salvage Radiation Therapy for Prostate Cancer Patients With a Choline PET-CT Positive Nodal Relapse G. Crehange,1 P. Maingon,2 A. Cueff,2 G. Truc,3 K. Peignaux,4 F. Mazoyer,3 N. Vulquin,1 M. Quivrin,1 S. Naudy,1 and E. Martin1; 1Centre Georges-Francois Leclerc, Dijon Cedex, France, 2Centre Georges Franc¸ois Leclerc, Dijon, France, 3Centre Georges Franc¸ois Leclerc, Dijon, France, 4Centre GF Leclerc, Dijon, France Purpose/Objective(s): 18F or 11C choline positron emission tomographyecomputed tomography (PET-CT) has significantly improved the detection of occult nodal relapse in prostate cancer patients with a rising prostate-specific antigen (PSA) level after radical prostatectomy and/or external radiation therapy (RT). In parallel, focal hypofractionated stereotactic body RT (fSBRT) is an emerging salvage RT (sRT) for oligometastatic diseases. It allows delivery of a very high biologically effective dose (BED) in few fractions but to a small volume (e.g., involved node only). In this preliminary report, we aimed to assess short-term biochemical response of focal SBRT versus protracted ENI in node-positive recurrent prostate cancer on choline PET-CT. Materials/Methods: Between 2009 and 2014, 102 patients underwent choline PET-TDM in our center. Of these, 37 had sRT without hormones for nodal relapse only. Patients underwent either fSBRT (nZ28) or protracted elective nodal irradiation (nZ 9) combined with a protracted boost to positive nodes (pENI). Patients treated with fSBRT received 30 to 45 Gy in 3 to 6 fractions while patients treated with pENI had 60 to 66Gy in 25 to 33 fractions. Failure was defined as PSA rising higher than pre-sRT on 2 consecutive samples or the initiation of any second salvage therapy. PSA nadir (nPSA), time to nPSA, and time to failure (TTF) were assessed. Results: The characteristics of patients and tumor at time of relapse were similar. The median PSA values at the time of sRT were 5.9 ng/mL (1.3; 17.3) with fSBRT and 6.9 ng/mL (0.5; 13.8) with pENI (PZNS); The median follow-up was 1.95 years (95% CI: 0.54-1.52). Fifteen failures occurred with fSBRT (51.7%) and 4 failures with pENI (44.4%). The median PSA nadir at 2 years was 0.57 (0.01-4.52) with fSBRT and 0.02 (0.01-0.07) with pENI (PZ.0004). The time to nPSA at 2 years was 17.61 months (0.20-23.62) with fSBRT and 8.46 months (5.19-18.37) with pENI (PZ.05). The median TTF was 2.89 years (95% CI: 1.24-4.65) with fSBRT and 4.73 years (95% CI: 0.40-ND) with pENI (PZ NS). Conclusion: Patients with a nodal relapse on fluorocholine PET-CT who were treated with pENI experienced a lower nPSA and shorter time to nPSA 2 years following completion of sRT than with fSBRT, consistent
with the eradication of micrometastatic disease in PET-negative nodes. Whether this translates into improved biochemical control and/or a clinical relapse needs longer follow-up. Author Disclosure: G. Crehange: None. P. Maingon: None. A. Cueff: None. G. Truc: None. K. Peignaux: None. F. Mazoyer: None. N. Vulquin: None. M. Quivrin: None. S. Naudy: None. E. Martin: None.
2605 Are Results From Intermediate-Risk Prostate Cancer Patients Treated Within Clinical Trials Applicable to Real Life? D. Taussky,1 J.P. Bahary,2 C. Lambert,1 M.C. Beauchemin,2 G. Delouya,1 M. Barkati,3 and X. Liem4; 1Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada, 2Hopital Notre-Dame du CHUM, Montreal, QC, Canada, 3Centre Hospitalier de l’Universite´ de Montre´al (CHUM), Montreal, QC, Canada, 4Univesrite Montreal, Montreal, QC, Canada Purpose/Objective(s): There is some doubt on whether clinical studies (CSs) have selective inclusion criteria that might not represent real-life patients (RLPs) and may limit their applicability to daily clinical practice. Patients in CSs and RLPs might have different comorbidities which can have an impact on overall survival. We assessed whether patients from CSs differ from patients not included in terms of comorbidity, prostate cancer aggressiveness, and biochemical recurrence. Materials/Methods: We identified 468 patients with D’Amico intermediaterisk prostate cancer from our institutional database all treated with external beam radiation therapy only. Three hundred seven patients were treated in a CS, including 2, multinational randomized trials (PROFIT and RTOG 0126), each including >80 patients from our center; one in-house phase 2 with >40 patients and some smaller randomized studies with <13 patients each. These CS patients were compared to 161 patients (RLPs) who were not included in any CS. Patients treated in CSs were compared to the RLPs using nonparametric tests. Logistic regression was performed to explore predictive factors of CS inclusion. Biochemical recurrence rate was estimated using the Kaplan-Meier method and compared using the log-rank test. Results: Median follow-up was 56 months (interquartile range 36-78 months). There was no difference in age (mean 70 years for both, PZ.95) or in cancer aggressiveness between both groups: PSA >10 ng/mL in 28% of CS patients and in 32% of RLPs (PZ.37). Gleason score 4+3 was found in 29% of CS patients and in 30% of RLPs (PZ.58). CS patients had more frequently hypertension (60% CS vs 46% RLPs, PZ.01), and more often hypercholesterolemia (51% for CS vs 43% in RLPs, PZ.01). In univariate analysis, myocardial infarction (PZ.05) and hypertension (PZ.003) were predictive of CS inclusion. On multivariate analysis, only hypertension was a significant predictor (hazard ratio [HR] 0.6, 95% confidence interval [CI] 0.4-0.9, PZ.012). The Cancer of the Prostate Risk Assessment score showed a trend toward a higher score in patients not treated in a CS (HR 1.15, 95 %CI 0.98-1.32, PZ.09). Biochemical recurrence-free survival was similar between both groups with a 5-year rate of 94% in both groups (PZ.65). Conclusion: In our exploratory analysis, we found that patients treated in CSs did not differ from RLPs in terms of age, prostate cancer aggressiveness, or biochemical outcome. Patients with comorbidity were more often included in CSs. The impact on overall survival remains unclear. In our institution, conclusions from CS can be transferred to daily practice. Author Disclosure: D. Taussky: None. J. Bahary: None. C. Lambert: None. M. Beauchemin: None. G. Delouya: None. M. Barkati: None. X. Liem: None.
2606 Results of Scanning Beam Proton Therapy (SCBT) for the Treatment of Patients With High-Risk Prostate Cancer S. Choi,1 Q. Nguyen,1 T.J. Pugh,1 U. Mahmood,1 S.E. McGuire,2 K.E. Hoffman,1 S.J. Frank,1 D.A. Kuban,1 and A.K. Lee3; 1MD Anderson Cancer Center, Houston, TX, 2The University of Texas MD Anderson Cancer Center, Houston, TX, 3Texas Center for Proton Therapy, Irving, TX