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Does Taxane-based Chemoradiation therapy Increase the Risk of Pneumonitis in the Treatment of Locally Advanced Esophageal Cancer?
S12
International Journal of Radiation Oncology Biology Physics
now, another 5 deaths were observed at other levels, all because of disease progression. Late toxicities remained under observation. Conclusions: Dose escalation in esophageal cancer has been safely achieved using SIB technique despite of difficulty in completion of consolidation chemotherapy. Acute toxicities of concurrent treatment were well tolerated and late toxicities deserved further observation. Author Disclosure: W. Yu: None. X. Fu: None. X. Cai: None. Q. Liu: None. W. Feng: None. Q. Zhang: None.
16
15 Failure Patterns after Definitive Chemoradiation Therapy with Involved-Field Irradiation for Locally Advanced Esophageal Squamous Cell Carcinoma M. Li,1 X. Zhang,2 Z. Liao,3 X. Meng,4 L. Kong,4 X. Zhang,4 F. Shi,4 Y. Zhang,4 G. Wei,2 H. Man,1 G. Zhang,1 and J. Yu4; 1Shandong Cancer Hospital and Institute, Jinan, China, 2Shandong Cancer Hospital and Institute, Jinan, China, 3The University of Texas MD Anderson Cancer Center, Houston, TX, 4Shandong Cancer Hospital, Jinan Shandong 250117, China Purpose/Objective(s): Because locally advanced esophageal squamous cell carcinoma (ESCC) is associated with high local failure rates and poor survival, the need for potentially toxic elective nodal irradiation is controversial. The purpose of this study was to investigate failure patterns and survival in patients with locally advanced ESCC after receipt of definitive concurrent chemoradiation with involved-field irradiation (IFI). Materials/Methods: A retrospective study was performed on the clinical records of patients with locally advanced ESCC, who have received IFI with concurrent chemotherapy between January 2003 and January 2009. The target volume included the esophageal lesion and clinically malignant nodes. No prophylactic nodal irradiation was used. We compared target volumes and first sites of failure; failures were defined as in-field, out-offield regional nodes, and distant failure. Survival was analyzed according to patterns of failure. Results: Complete data were available for 80 patients. At a median follow-up time of 52.6 months, 76 patients (95%) had experienced failure (43 [54%] in-field, 24 [30%] out-of-field regional, and 33 [41%] distant). Overall survival differed significantly by in-field recurrence (median 14.2 months with vs.17.4 months without, P Z 0.01) and by distant failure (13.2 months with vs.15.9 months without, P 0.0001), but not by out-of-field regional lymph node failure (both 14.5 months, P Z 0.665). The failure rate of in-field alone, distant alone, and out-offield regional LN alone were 40%, 16.25%, and 12.5%, respectively. All of the 10 cases with solitary regional LN failure received salvage treatment and 4 of them experienced more than 24 months survival period. Conclusions: The predominant failure patterns after definitive chemoradiation with IFI for locally advanced ESCC were in-field and distant, and both negatively influenced survival. Having a solitary failure in an out-offield regional node did not influence survival. Further investigation is needed to establish the optimal radiotherapy fields for patients with advanced disease. Author Disclosure: M. Li: None. X. Zhang: None. Z. Liao: None. X. Meng: None. L. Kong: None. X. Zhang: None. F. Shi: None. Y. Zhang: None. G. Wei: None. H. Man: None. G. Zhang: None. J. Yu: None. Oral Scientific Abstract 15; Table
Prognostic Significance Of FDG-PET Metrics In Esophageal Squamous Cell Carcinoma A.M. Chhabra,1,2 L.T. Ong,1,3 D. Kuk,4 G. Ku,5 D. Ilson,5 Y.Y. Janjigian,5 A. Wu,2 H. Scho¨der,1,3 and K.A. Goodman1,2; 1Authors equally contributed to this paper, Memorial Sloan Kettering Cancer Center, NY, 2 Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, 3Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, 4Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, 5Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY Purpose/Objectives: Fluorodeoxyglucose (FDG) avidity as measured by the maximum standard uptake value (SUV) at baseline and after induction chemotherapy (CT) on positron emission tomography (PET) imaging has been shown to be prognostic in patients with esophageal adenocarcinoma; however, the role of FDG PET in esophageal squamous cell carcinoma (SCC) has not been well established. We investigated the prognostic significance of various FDG metrics in a cohort of esophageal SCC patients treated with chemoradiation (CRT). Materials/Methods: We identified 58 esophageal SCC patients with fully analyzable FDG-PET data at baseline, post-induction CT and post-CRT. All patients received concurrent CRT, of which 53 patients also received induction CT and 11 patients underwent surgery following CRT. Median radiation dose was 5040 cGy (range 5040-5600 cGy). All scans were independently analyzed by a nuclear medicine physician blinded to patient outcome. Using region of interest analysis, max and mean standardized uptake value (SUVmax, SUVmean), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) were calculated for the index lesion and nodes in each patient. Kaplan-Meier analysis was used to evaluate overall survival (OS), disease free survival (DFS), local recurrence free survival (LRFS), and distant metastasis free survival (DMFS). The log-rank test was used to assess correlation between outcomes and FDG-PET metrics. Results: Median follow-up was 3.8 years, with median survival for all patients of 2.9 years. The 3-year OS, DFS, DMFS, and LRFS rates were 49%, 47%, 43%, and 42%, respectively. Using a pre-established cutoff of a 35% decrease in SUVmax from baseline to post-induction PET, 3 yr OS for responders ( 35% decrease from baseline) was 52%, whereas nonresponders (< 35% decrease from baseline) had a 3 yr OS of 21% (p Z 0.046). Baseline SUVmax, SUVpeak, MTV, and TLG were significantly associated with OS, LRFS, DFS, and DMFS. On post-induction PET, SUVmax, SUVpeak, MTV, and TLG were significantly associated with OS, LRFS, DMFS, and DFS. After completion of CRT, only SUVmax was prognostic for OS, while only SUVmax and TLG were prognostic for DMFS. Conclusion: Baseline and post-induction PET metrics were most prognostic in patients with esophageal SCC. Our data confirms a 35% decrease in SUVmax after induction CT, as established in the adenocarcinoma literature, is also a significant predictor of OS in esophageal SCC patients. This analysis demonstrates that in addition to SUVmax, volumetric PET metrics may also be useful in predicting outcomes. Author Disclosure: A.M. Chhabra: None. L.T. Ong: None. D. Kuk: None. G. Ku: None. D. Ilson: None. Y.Y. Janjigian: None. A. Wu: None. H. Scho¨der: None. K.A. Goodman: None.
The Failure Patterns
Location of Failure
No. of Patients
In-field with or without others In-field alone Out-of-field with or without others Out-of-field alone Supraclavicular Mediastinal Celiac Distant with or without others Distant alone
43 32 24 10 3 3 4 33 13
17 Does Taxane-based Chemoradiation therapy Increase the Risk of Pneumonitis in the Treatment of Locally Advanced Esophageal Cancer? M.M. Dominello,1 T. Shaikh,2 M. Zaki,1 O. Zamen,1 N. Hurst,1 J. Martin,2 E. McSpadden,1 A. Shields,1 P. Phillip,1 J. Meyer,2 and A. Konski1; 1 Wayne State University, Detroit, MI, 2Fox Chase Cancer Center, Philadelphia, PA
Volume 90 Number 1S Supplement 2014 Purpose/Objective(s): A recently published randomized controlled trial (RCT) compared surgery alone with carboplatin/paclitaxel-based chemoradiation therapy (CRT) followed by surgery for locally advanced esophageal cancer. In this trial, 46% of patients in the CRT arm experienced post-operative pulmonary complications including atelectasis, pneumothorax, effusion, pulmonary embolus, and acute respiratory failure, but clinical chemoradiation pneumonitis (CRP) rates were not explicitly described for this CRT regimen. We present our bi-institutional experience describing CRT-related CRP rates for patients receiving concurrent therapy and assess factors influencing toxicity. We hypothesize that patients receiving taxane-based chemotherapy will have similar rates of clinical radiation pneumonitis to patients receiving non-taxane-based chemotherapy. Materials/Methods: Following IRB approval, a review of 193 patients with locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus who underwent CRT from 2000-2013 at 2 NCIdesignated cancer centers was conducted. All 193 patients received CRT, with 132 (68%) going on to surgery. Concurrent chemotherapy was often 5-fluorouracil/cisplatin or carboplatin/paclitaxel though other combinations were used. Radiotherapy was delivered to a total dose of 30-60 Gy, median 50.4 Gy at 1.8-3.0 Gy per fraction with three-dimensional conformal or intensity modulated technique. Cardiac and lung dose parameters were generated from the dose-volume histogram (DVH). Pulmonary function test (PFT) results were recorded. Clinic notes were reviewed for CRP and graded per CTCAE v. 4.0. A regression analysis was used to determine the relationship between CRP and DVH/PFT results. Relationship between pneumonitis and chemotherapy type was tested using a chi-square frequency test. Results: Of the 193 patients, 27 (14%) experienced CRP (1 patient with Grade 3, 14 with Grade 2, 12 with Grade 1). Twelve (20%) of the 61 patients receiving taxane-based CRT experienced CRP versus the 15 (11%) of the 132 patients not receiving taxane-based therapy (p Z 0.16). Among the patients with evaluable DVH and PFT data, total lung V5 predicted for CRP (p Z 0.005), whereas V20 (p Z 0.37), mean heart dose (p Z 0.29), prescription dose (p Z 0.11), forced expiratory volume 1 second (p Z 0.75), and diffusion capacity (p Z 0.53) were not significantly associated with CRP. Conclusions: In our bi-institution experience, lung V5 was the only variable predictive of CRP. In this series we failed to demonstrate a statistically significant difference in CRP rates for patients receiving taxane versus non-taxane-based CRT in the management of esophageal cancer. A RCT will be required to determine the optimal neoadjuvant CRT regimen and radiation dose. We recommend continued attention to total lung V5 when treatment planning. Author Disclosure: M.M. Dominello: None. T. Shaikh: None. M. Zaki: None. O. Zamen: None. N. Hurst: None. J. Martin: None. E. McSpadden: None. A. Shields: None. P. Phillip: None. J. Meyer: None. A. Konski: None.
18 Impact of Node Status and Radiotherapy on Failure-Free Survival in Patients With NewlyeDiagnosed Non-Metastatic Prostate Cancer: Data From >690 Patients in the Control Arm of the STAMPEDE Trial N.D. James,1 M.R. Spears,2 N.W. Clarke,3 M.R. Sydes,2 C.C. Parker,4 D.P. Dearnaley,4 J.M. Russell,5 A.W.S. Ritchie,2 G. Thalmann,6 J.S. De Bono,4 G. Attard,4 C. Amos,2 M.K. Parmar,2 and M.D. Mason7; 1 University of Warwick, Coventry, United Kingdom, 2MRC Clinical Trials Unit at UCL, London, United Kingdom, 3Dept of Urology, The Christie NHS Foundation Trust, Manchester, United Kingdom, 4Institute of Cancer Research/Royal Marsden Hospitals NHS Foundation Trust, London, United Kingdom, 5Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 6Dept of Urology, University of Bern, Bern, Switzerland, 7 Cardiff University School of Medicine, Velindre Hospital, Cardiff, United Kingdom
Oral Scientific Sessions
S13
Purpose/Objective(s): The natural history of patients with newlyediagnosed high-risk non-metastatic (M0) prostate cancer receiving androgen deprivation therapy (ADT) either alone or with standard-of-care radiotherapy (RT) at 6 to 9 months is not well documented. Furthermore, no RCT has assessed the role of RT in N + M0 patients and none are planned. The STAMPEDE trial (NCT00268476; MRC PR08; CRUK/06/ 019) includes such individuals and allows an exploratory multivariate analysis of the impact of radical RT. We report data here from trial patients. We hypothesized that planning RT in N + M0 patients improves survival outcomes. Materials/Methods: Newly-diagnosed patients with confirmed M0 disease in the trial’s control arm (standard-of-care based on ADT planned for 2 yr), diagnosed < 6 months before randomization, and on ADT for 0-12 weeks already, were identified from trial records in January 2014. RT has been encouraged in this group, but only mandated for N0M0 patients since November 2011. We report failure-free survival (FFS) driven by PSA failure, and overall survival (OS), split by nodal involvement and reported radiotherapy status. Standard survival analysis methods were used, adjusting for age and PSA. Results: Five thousand two hundred seventy-two men were recruited to STAMPEDE from October 2005 to January 2014, including a cohort of 694 M0 men with newly-diagnosed disease allocated to the control arm: median age 66 yr (IQR 61-71), median time from diagnosis to randomization 2.6 m (IQR 2.0-3.3) and median PSA 42 ng/ml (IQR 17-88) at diagnosis. By January 7, 2014, there were 34 deaths, including 25 from prostate cancer. Median follow-up is short, but 2 yr overall survival is 95% (95% CI Z 92, 97) and 2 yr FFS is 79% (95% CI Z 75, 83). Median FFS is 63 months; 79% (n Z 94/119) report PSA failure-only as their first FFS event. Time to FFS is worse in patients reporting nodal involvement (HR Z 1.87, 95% CI Z 1.29-2.72). Baseline characteristics were comparable by planned RT status, except for N0M0 patients planned for RT had lower PSA at diagnosis and a higher proportion with WHO PS Z 0. The Table shows that FFS outcomes clearly favor the planned use of RT for both N0M0 and N + M0 patients. Oral Scientific Abstract 18; Table Group N0M0 not planned for RT N0M0 planned for RT N + M0 not planned for RT N + M0 planned for RT
No. Pts 2-year FFS (95% CI) 59 121 71 84
69% 94% 55% 85%
(56% (88% (41% (75%
-
79%) 97%) 67%) 91%)
Adjusted HR (95% CI) Reference 0.33 (0.18e0.62) Reference 0.45 (0.25e0.80)
Conclusions: Survival at 2 years is encouraging in M0 patients and higher than anticipated at study inception. These prospectively collected, nonrandomized data strongly support routine use of RT with ADT in N0M0 patients consistent with MRC PR07/NCIC PR.3 and SPCG7. Furthermore, the data suggest that the advantage may extend to N + M0 disease too. Author Disclosure: N.D. James: None. M.R. Spears: None. N.W. Clarke: None. M.R. Sydes: None. C.C. Parker: None. D.P. Dearnaley: None. J.M. Russell: None. A.W.S. Ritchie: None. G. Thalmann: None. J.S. De Bono: None. G. Attard: None. C. Amos: None. M.K. Parmar: None. M.D. Mason: None.
19 Radiation Therapy for Clinically Node-Positive Prostate Cancer and Survival: Results from the National Cancer Data Base C. Lin,1 P.J. Gray,2 A. Jemal,1 and J.A. Efstathiou3; 1American Cancer Society, Atlanta, GA, 2Harvard Radiation Oncology Program, Boston, MA, 3 Massachusetts General Hospital, Boston, MA Purpose/Objective(s): The addition of radiation therapy (RT) to androgen deprivation therapy (ADT) in the management of clinically node-positive (LN+) intact prostate cancer (PCa) has increased in recent years despite lack of randomized trial to support such practice. This study assesses the effect of the addition of RT to ADT alone on survival using a large national cancer outcome database.
International Journal of Radiation Oncology Biology Physics
now, another 5 deaths were observed at other levels, all because of disease progression. Late toxicities remained under observation. Conclusions: Dose escalation in esophageal cancer has been safely achieved using SIB technique despite of difficulty in completion of consolidation chemotherapy. Acute toxicities of concurrent treatment were well tolerated and late toxicities deserved further observation. Author Disclosure: W. Yu: None. X. Fu: None. X. Cai: None. Q. Liu: None. W. Feng: None. Q. Zhang: None.
16
15 Failure Patterns after Definitive Chemoradiation Therapy with Involved-Field Irradiation for Locally Advanced Esophageal Squamous Cell Carcinoma M. Li,1 X. Zhang,2 Z. Liao,3 X. Meng,4 L. Kong,4 X. Zhang,4 F. Shi,4 Y. Zhang,4 G. Wei,2 H. Man,1 G. Zhang,1 and J. Yu4; 1Shandong Cancer Hospital and Institute, Jinan, China, 2Shandong Cancer Hospital and Institute, Jinan, China, 3The University of Texas MD Anderson Cancer Center, Houston, TX, 4Shandong Cancer Hospital, Jinan Shandong 250117, China Purpose/Objective(s): Because locally advanced esophageal squamous cell carcinoma (ESCC) is associated with high local failure rates and poor survival, the need for potentially toxic elective nodal irradiation is controversial. The purpose of this study was to investigate failure patterns and survival in patients with locally advanced ESCC after receipt of definitive concurrent chemoradiation with involved-field irradiation (IFI). Materials/Methods: A retrospective study was performed on the clinical records of patients with locally advanced ESCC, who have received IFI with concurrent chemotherapy between January 2003 and January 2009. The target volume included the esophageal lesion and clinically malignant nodes. No prophylactic nodal irradiation was used. We compared target volumes and first sites of failure; failures were defined as in-field, out-offield regional nodes, and distant failure. Survival was analyzed according to patterns of failure. Results: Complete data were available for 80 patients. At a median follow-up time of 52.6 months, 76 patients (95%) had experienced failure (43 [54%] in-field, 24 [30%] out-of-field regional, and 33 [41%] distant). Overall survival differed significantly by in-field recurrence (median 14.2 months with vs.17.4 months without, P Z 0.01) and by distant failure (13.2 months with vs.15.9 months without, P 0.0001), but not by out-of-field regional lymph node failure (both 14.5 months, P Z 0.665). The failure rate of in-field alone, distant alone, and out-offield regional LN alone were 40%, 16.25%, and 12.5%, respectively. All of the 10 cases with solitary regional LN failure received salvage treatment and 4 of them experienced more than 24 months survival period. Conclusions: The predominant failure patterns after definitive chemoradiation with IFI for locally advanced ESCC were in-field and distant, and both negatively influenced survival. Having a solitary failure in an out-offield regional node did not influence survival. Further investigation is needed to establish the optimal radiotherapy fields for patients with advanced disease. Author Disclosure: M. Li: None. X. Zhang: None. Z. Liao: None. X. Meng: None. L. Kong: None. X. Zhang: None. F. Shi: None. Y. Zhang: None. G. Wei: None. H. Man: None. G. Zhang: None. J. Yu: None. Oral Scientific Abstract 15; Table
Prognostic Significance Of FDG-PET Metrics In Esophageal Squamous Cell Carcinoma A.M. Chhabra,1,2 L.T. Ong,1,3 D. Kuk,4 G. Ku,5 D. Ilson,5 Y.Y. Janjigian,5 A. Wu,2 H. Scho¨der,1,3 and K.A. Goodman1,2; 1Authors equally contributed to this paper, Memorial Sloan Kettering Cancer Center, NY, 2 Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, 3Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, 4Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, 5Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY Purpose/Objectives: Fluorodeoxyglucose (FDG) avidity as measured by the maximum standard uptake value (SUV) at baseline and after induction chemotherapy (CT) on positron emission tomography (PET) imaging has been shown to be prognostic in patients with esophageal adenocarcinoma; however, the role of FDG PET in esophageal squamous cell carcinoma (SCC) has not been well established. We investigated the prognostic significance of various FDG metrics in a cohort of esophageal SCC patients treated with chemoradiation (CRT). Materials/Methods: We identified 58 esophageal SCC patients with fully analyzable FDG-PET data at baseline, post-induction CT and post-CRT. All patients received concurrent CRT, of which 53 patients also received induction CT and 11 patients underwent surgery following CRT. Median radiation dose was 5040 cGy (range 5040-5600 cGy). All scans were independently analyzed by a nuclear medicine physician blinded to patient outcome. Using region of interest analysis, max and mean standardized uptake value (SUVmax, SUVmean), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) were calculated for the index lesion and nodes in each patient. Kaplan-Meier analysis was used to evaluate overall survival (OS), disease free survival (DFS), local recurrence free survival (LRFS), and distant metastasis free survival (DMFS). The log-rank test was used to assess correlation between outcomes and FDG-PET metrics. Results: Median follow-up was 3.8 years, with median survival for all patients of 2.9 years. The 3-year OS, DFS, DMFS, and LRFS rates were 49%, 47%, 43%, and 42%, respectively. Using a pre-established cutoff of a 35% decrease in SUVmax from baseline to post-induction PET, 3 yr OS for responders ( 35% decrease from baseline) was 52%, whereas nonresponders (< 35% decrease from baseline) had a 3 yr OS of 21% (p Z 0.046). Baseline SUVmax, SUVpeak, MTV, and TLG were significantly associated with OS, LRFS, DFS, and DMFS. On post-induction PET, SUVmax, SUVpeak, MTV, and TLG were significantly associated with OS, LRFS, DMFS, and DFS. After completion of CRT, only SUVmax was prognostic for OS, while only SUVmax and TLG were prognostic for DMFS. Conclusion: Baseline and post-induction PET metrics were most prognostic in patients with esophageal SCC. Our data confirms a 35% decrease in SUVmax after induction CT, as established in the adenocarcinoma literature, is also a significant predictor of OS in esophageal SCC patients. This analysis demonstrates that in addition to SUVmax, volumetric PET metrics may also be useful in predicting outcomes. Author Disclosure: A.M. Chhabra: None. L.T. Ong: None. D. Kuk: None. G. Ku: None. D. Ilson: None. Y.Y. Janjigian: None. A. Wu: None. H. Scho¨der: None. K.A. Goodman: None.
The Failure Patterns
Location of Failure
No. of Patients
In-field with or without others In-field alone Out-of-field with or without others Out-of-field alone Supraclavicular Mediastinal Celiac Distant with or without others Distant alone
43 32 24 10 3 3 4 33 13
17 Does Taxane-based Chemoradiation therapy Increase the Risk of Pneumonitis in the Treatment of Locally Advanced Esophageal Cancer? M.M. Dominello,1 T. Shaikh,2 M. Zaki,1 O. Zamen,1 N. Hurst,1 J. Martin,2 E. McSpadden,1 A. Shields,1 P. Phillip,1 J. Meyer,2 and A. Konski1; 1 Wayne State University, Detroit, MI, 2Fox Chase Cancer Center, Philadelphia, PA
Volume 90 Number 1S Supplement 2014 Purpose/Objective(s): A recently published randomized controlled trial (RCT) compared surgery alone with carboplatin/paclitaxel-based chemoradiation therapy (CRT) followed by surgery for locally advanced esophageal cancer. In this trial, 46% of patients in the CRT arm experienced post-operative pulmonary complications including atelectasis, pneumothorax, effusion, pulmonary embolus, and acute respiratory failure, but clinical chemoradiation pneumonitis (CRP) rates were not explicitly described for this CRT regimen. We present our bi-institutional experience describing CRT-related CRP rates for patients receiving concurrent therapy and assess factors influencing toxicity. We hypothesize that patients receiving taxane-based chemotherapy will have similar rates of clinical radiation pneumonitis to patients receiving non-taxane-based chemotherapy. Materials/Methods: Following IRB approval, a review of 193 patients with locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus who underwent CRT from 2000-2013 at 2 NCIdesignated cancer centers was conducted. All 193 patients received CRT, with 132 (68%) going on to surgery. Concurrent chemotherapy was often 5-fluorouracil/cisplatin or carboplatin/paclitaxel though other combinations were used. Radiotherapy was delivered to a total dose of 30-60 Gy, median 50.4 Gy at 1.8-3.0 Gy per fraction with three-dimensional conformal or intensity modulated technique. Cardiac and lung dose parameters were generated from the dose-volume histogram (DVH). Pulmonary function test (PFT) results were recorded. Clinic notes were reviewed for CRP and graded per CTCAE v. 4.0. A regression analysis was used to determine the relationship between CRP and DVH/PFT results. Relationship between pneumonitis and chemotherapy type was tested using a chi-square frequency test. Results: Of the 193 patients, 27 (14%) experienced CRP (1 patient with Grade 3, 14 with Grade 2, 12 with Grade 1). Twelve (20%) of the 61 patients receiving taxane-based CRT experienced CRP versus the 15 (11%) of the 132 patients not receiving taxane-based therapy (p Z 0.16). Among the patients with evaluable DVH and PFT data, total lung V5 predicted for CRP (p Z 0.005), whereas V20 (p Z 0.37), mean heart dose (p Z 0.29), prescription dose (p Z 0.11), forced expiratory volume 1 second (p Z 0.75), and diffusion capacity (p Z 0.53) were not significantly associated with CRP. Conclusions: In our bi-institution experience, lung V5 was the only variable predictive of CRP. In this series we failed to demonstrate a statistically significant difference in CRP rates for patients receiving taxane versus non-taxane-based CRT in the management of esophageal cancer. A RCT will be required to determine the optimal neoadjuvant CRT regimen and radiation dose. We recommend continued attention to total lung V5 when treatment planning. Author Disclosure: M.M. Dominello: None. T. Shaikh: None. M. Zaki: None. O. Zamen: None. N. Hurst: None. J. Martin: None. E. McSpadden: None. A. Shields: None. P. Phillip: None. J. Meyer: None. A. Konski: None.
18 Impact of Node Status and Radiotherapy on Failure-Free Survival in Patients With NewlyeDiagnosed Non-Metastatic Prostate Cancer: Data From >690 Patients in the Control Arm of the STAMPEDE Trial N.D. James,1 M.R. Spears,2 N.W. Clarke,3 M.R. Sydes,2 C.C. Parker,4 D.P. Dearnaley,4 J.M. Russell,5 A.W.S. Ritchie,2 G. Thalmann,6 J.S. De Bono,4 G. Attard,4 C. Amos,2 M.K. Parmar,2 and M.D. Mason7; 1 University of Warwick, Coventry, United Kingdom, 2MRC Clinical Trials Unit at UCL, London, United Kingdom, 3Dept of Urology, The Christie NHS Foundation Trust, Manchester, United Kingdom, 4Institute of Cancer Research/Royal Marsden Hospitals NHS Foundation Trust, London, United Kingdom, 5Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 6Dept of Urology, University of Bern, Bern, Switzerland, 7 Cardiff University School of Medicine, Velindre Hospital, Cardiff, United Kingdom
Oral Scientific Sessions
S13
Purpose/Objective(s): The natural history of patients with newlyediagnosed high-risk non-metastatic (M0) prostate cancer receiving androgen deprivation therapy (ADT) either alone or with standard-of-care radiotherapy (RT) at 6 to 9 months is not well documented. Furthermore, no RCT has assessed the role of RT in N + M0 patients and none are planned. The STAMPEDE trial (NCT00268476; MRC PR08; CRUK/06/ 019) includes such individuals and allows an exploratory multivariate analysis of the impact of radical RT. We report data here from trial patients. We hypothesized that planning RT in N + M0 patients improves survival outcomes. Materials/Methods: Newly-diagnosed patients with confirmed M0 disease in the trial’s control arm (standard-of-care based on ADT planned for 2 yr), diagnosed < 6 months before randomization, and on ADT for 0-12 weeks already, were identified from trial records in January 2014. RT has been encouraged in this group, but only mandated for N0M0 patients since November 2011. We report failure-free survival (FFS) driven by PSA failure, and overall survival (OS), split by nodal involvement and reported radiotherapy status. Standard survival analysis methods were used, adjusting for age and PSA. Results: Five thousand two hundred seventy-two men were recruited to STAMPEDE from October 2005 to January 2014, including a cohort of 694 M0 men with newly-diagnosed disease allocated to the control arm: median age 66 yr (IQR 61-71), median time from diagnosis to randomization 2.6 m (IQR 2.0-3.3) and median PSA 42 ng/ml (IQR 17-88) at diagnosis. By January 7, 2014, there were 34 deaths, including 25 from prostate cancer. Median follow-up is short, but 2 yr overall survival is 95% (95% CI Z 92, 97) and 2 yr FFS is 79% (95% CI Z 75, 83). Median FFS is 63 months; 79% (n Z 94/119) report PSA failure-only as their first FFS event. Time to FFS is worse in patients reporting nodal involvement (HR Z 1.87, 95% CI Z 1.29-2.72). Baseline characteristics were comparable by planned RT status, except for N0M0 patients planned for RT had lower PSA at diagnosis and a higher proportion with WHO PS Z 0. The Table shows that FFS outcomes clearly favor the planned use of RT for both N0M0 and N + M0 patients. Oral Scientific Abstract 18; Table Group N0M0 not planned for RT N0M0 planned for RT N + M0 not planned for RT N + M0 planned for RT
No. Pts 2-year FFS (95% CI) 59 121 71 84
69% 94% 55% 85%
(56% (88% (41% (75%
-
79%) 97%) 67%) 91%)
Adjusted HR (95% CI) Reference 0.33 (0.18e0.62) Reference 0.45 (0.25e0.80)
Conclusions: Survival at 2 years is encouraging in M0 patients and higher than anticipated at study inception. These prospectively collected, nonrandomized data strongly support routine use of RT with ADT in N0M0 patients consistent with MRC PR07/NCIC PR.3 and SPCG7. Furthermore, the data suggest that the advantage may extend to N + M0 disease too. Author Disclosure: N.D. James: None. M.R. Spears: None. N.W. Clarke: None. M.R. Sydes: None. C.C. Parker: None. D.P. Dearnaley: None. J.M. Russell: None. A.W.S. Ritchie: None. G. Thalmann: None. J.S. De Bono: None. G. Attard: None. C. Amos: None. M.K. Parmar: None. M.D. Mason: None.
19 Radiation Therapy for Clinically Node-Positive Prostate Cancer and Survival: Results from the National Cancer Data Base C. Lin,1 P.J. Gray,2 A. Jemal,1 and J.A. Efstathiou3; 1American Cancer Society, Atlanta, GA, 2Harvard Radiation Oncology Program, Boston, MA, 3 Massachusetts General Hospital, Boston, MA Purpose/Objective(s): The addition of radiation therapy (RT) to androgen deprivation therapy (ADT) in the management of clinically node-positive (LN+) intact prostate cancer (PCa) has increased in recent years despite lack of randomized trial to support such practice. This study assesses the effect of the addition of RT to ADT alone on survival using a large national cancer outcome database.