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Proctitis One Week After Stereotactic Body Radiation Therapy for Prostate Cancer: Implications for Clinical Trial Design
E486
International Journal of Radiation Oncology Biology Physics
Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA
was assessed using the bowel domain of the EPIC-26 questionnaire at baseline, one week, one month, and three months. Time-dependent changes in bowel QOL were statistically compared using the Wilcoxon signed-rank test. Results: One hundred and three patients with a minimum of three months of follow-up were analyzed. Acute Grade 2 rectal frequency and urgency occurred in 24 patients (23%). There were no grade 3 or greater bowel toxicities; EPIC bowel summary scores maximally declined at 1 week post-SBRT (-13.9, P<.0001) before returning to baseline at three months post-SBRT (+0.03, PZ.9370). All bowel symptoms increased at one week post-SBRT but returned to near baseline at three months. Prior to treatment, 4.9% of men reported that their bowel function was a moderate to big problem. This increased to 28.4% (P<.0001) one week post-SBRT and returned to baseline at three months post-SBRT (0.0%, PZ.6583). Conclusion: In this single-institution cohort, the rate and severity of acute proctitis following prostate SBRT was highest one week after treatment and returned to baseline by 3 months. Collection of patient reported quality of life data at one week would minimize recall bias and increase the accuracy of patient reported toxicities on quality of life questionnaires. The data from this study should aid in the design of future clinical trials focused on minimizing acute toxicity following SBRT. Author Disclosure: I. Paydar: None. R.A. Cyr: None. T. Yung: None. S. Lei: None. B.T. Collins: Consultant; Accuray Inc. L. Chen: None. S. Suy: None. A. Dritschilo: None. J.H. Lynch: None. S.P. Collins: Consultant; Accuray Inc.
Purpose/Objective(s): Due to the rarity of clear cell endometrial carcinoma, only several limited studies with small patient size have been reported. The impact of adjuvant radiation therapy (RT) and/or chemotherapy (CT) is controversial. We conducted a National Cancer Data Base (NCDB) analysis to evaluate the survival benefit of adjuvant RT and CT. Materials/Methods: The NCDB was queried for patients with stage I-II clear cell endometrial carcinoma, diagnosed from 1998 through 2011. Patients receiving neoadjuvant therapy, not undergoing surgical staging (total hysterectomy and bilateral salpingo-oopherectomy), or without adjuvant treatment characteristics were excluded. Bivariate regression was conducted to establish factors associated with treatment utilization. Propensity scores were calculated using multivariate logistic regression with forward conditional selection (P<.10) for each treatment approach. Logrank test and multivariate Cox proportional hazards modeling with propensity score adjustment were conducted to identify factors associated with adjuvant RT and CT utilization and their subsequent survival impact. Results: A total of 2078 patients were identified. All patients received surgical staging with confirmed negative regional lymph nodes. Four hundred eight (19.6%) patients received adjuvant CT, and 833 (40.1%) received adjuvant RT. Radiation therapy utilization ranged from 30.745.9% with no significant change over time (PZ.21); RT utilization was higher among patients receiving CT (OR 1.84, P<.001), with FIGO stage II disease (OR 2.12, P<.001), and treated at facilities in the bottom volume quartile (OR 1.81, PZ.003). Radiation therapy was less likely to be delivered to patients living a greater distance from treatment facilities (>30 miles: OR 0.51, P<.001). Computed tomography utilization increased over time from 5.1% in 1998-2003 to 36.3% in 2009-2011 (P<.001); CT utilization was higher for patients receiving RT (OR 2.41, P<.001) and with FIGO stage II disease (OR 2.03, P<.001) and was lower for patients with advanced age (>75 years: OR 0.31, P<.001). With a median follow-up of 71.9 months, the 6-year estimated survival for patients treated with no adjuvant therapy, RT alone, CT alone, and CT+RT were 73.6, 67.4, 66.9, and 76.6%, respectively (PZ.073). Neither delivery of adjuvant RT (HR 1.00, 95% CI 0.72-1.40, PZ.981) nor adjuvant CT (HR 1.11, 95% CI 0.70-1.76, PZ.649) were associated with improved survival. Conclusion: Despite evaluating a favorable subset of patients with an aggressive histologic variant of endometrial cancer, no demonstrated survival impact was seen from adjuvant therapy. The impact of adjuvant therapy on local control and progression-free survival as well as pathologic features such as lymphovascular invasion should be further investigated for these patients, given inability to capture such data in the present analysis. Author Disclosure: K.M. Xu: None. B.S. Gill: None. G. Balasubramani: None. P. Sukumvanich: None. T.C. Krivak: None. S. Beriwal: None.
3214 Proctitis One Week After Stereotactic Body Radiation Therapy for Prostate Cancer: Implications for Clinical Trial Design I. Paydar,1 R.A. Cyr,1 T. Yung,1 S. Lei,2 B.T. Collins,1 L. Chen,1 S. Suy,2 A. Dritschilo,2 J.H. Lynch,1 and S.P. Collins2; 1Georgetown University Medical Center, Washington, DC, 2Georgetown University Hospital, Washington, DC Purpose/Objective(s): Proctitis after radiation therapy for prostate cancer is a primary determinant of quality of life and remains an ongoing clinical challenge. While previous studies have described acute rectal toxicity at 1 month after treatment with SBRT, little data exist on the development of rectal toxicity within the first week of treatment. This study reported the acute bowel morbidity following prostate SBRT from a single institution. Materials/Methods: From May 2013 through August 2014, 103 patients with clinically localized prostate cancer were treated with 35 to 36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4). Bowel quality of life (QOL)
3215 Quality of Life (QOL) Following Sequential Boost Regimen (SB) With Helical Tomotherapy Intensity Modulated Radiation Therapy (HTIMRT) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN): A Prospective Study S. El-Sayed,1 M.Y. Almaghrabi,1 and H. Marginean2; 1University of Ottawa, Ottawa, ON, Canada, 2Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada Purpose/Objective(s): Radiation therapy delivery using IMRT in SCCHN was quickly adopted despite the lack of detailed toxicity data. Randomized data now exists as to the significant impact on the incidence of mucositis. Little data exists as to the impact on quality of life (QOL). This analysis is part of a larger study profiling the toxicity of HTIMRT. The objective of this analysis was to evaluate the impact of HTIMRT on QOL of patients treated for SCCHN and to compare that to what is reported in the literature using 3D conformal XRT. Materials/Methods: This prospective study was carried out from 2006 e 2012; HTIMRT was delivered in 70 Gy in 35 fractions (XRT) of an SB regimen. Patient-rated EORTC QLQ-C30 and EORTC QLQ H&N 35 scores have been collected preradiation therapy, 2/4/6/7/8 weeks during the treatment, and 2/4/6/8/12/24 weeks post radiation therapy. Scoring procedures was done using EORTC QLQ-C30 scoring manual, third edition. Clinically relevant changes were defined as moderate and large changes in quality of life (> 10 scores). Adjustment was performed with pretherapy scores. Results: Quality of life data for 87 evaluable patients were available including pretherapy baseline (BL) questionnaires. Forty-eight percent received concomitant chemotherapy (CRT). For EORTC QLQ-C30 module, the impact of HTIMRT during radiation therapy was large (>20 scores) at fourth week (on role functioning, appetite loss, and constipation subscales) and sixth week (on global QOL, social functioning, fatigue, nausea/vomiting, and pain subscales). Significant posttreatment recovery (>10 improved scores) occurred at 2 weeks (for appetite loss subscales), 4 weeks (for social functioning, fatigue, pain, and constipation subscales), and 6 weeks (for global QOL, physical functioning, cognitive functioning, role functioning, and nausea/vomiting subscales). Global QOL improved to a level above BL by 24 weeks. All subscales return to BL values except for role functioning, appetite loss, and financial difficulty subscales. Disease-specific problems measured by EORTC QLQ H&N 35 divulged the most unpleasant scores. Symptoms such as swallowing, senses, social eating, sexuality, dry mouth, sticky saliva, nutritional supplement, and
International Journal of Radiation Oncology Biology Physics
Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA
was assessed using the bowel domain of the EPIC-26 questionnaire at baseline, one week, one month, and three months. Time-dependent changes in bowel QOL were statistically compared using the Wilcoxon signed-rank test. Results: One hundred and three patients with a minimum of three months of follow-up were analyzed. Acute Grade 2 rectal frequency and urgency occurred in 24 patients (23%). There were no grade 3 or greater bowel toxicities; EPIC bowel summary scores maximally declined at 1 week post-SBRT (-13.9, P<.0001) before returning to baseline at three months post-SBRT (+0.03, PZ.9370). All bowel symptoms increased at one week post-SBRT but returned to near baseline at three months. Prior to treatment, 4.9% of men reported that their bowel function was a moderate to big problem. This increased to 28.4% (P<.0001) one week post-SBRT and returned to baseline at three months post-SBRT (0.0%, PZ.6583). Conclusion: In this single-institution cohort, the rate and severity of acute proctitis following prostate SBRT was highest one week after treatment and returned to baseline by 3 months. Collection of patient reported quality of life data at one week would minimize recall bias and increase the accuracy of patient reported toxicities on quality of life questionnaires. The data from this study should aid in the design of future clinical trials focused on minimizing acute toxicity following SBRT. Author Disclosure: I. Paydar: None. R.A. Cyr: None. T. Yung: None. S. Lei: None. B.T. Collins: Consultant; Accuray Inc. L. Chen: None. S. Suy: None. A. Dritschilo: None. J.H. Lynch: None. S.P. Collins: Consultant; Accuray Inc.
Purpose/Objective(s): Due to the rarity of clear cell endometrial carcinoma, only several limited studies with small patient size have been reported. The impact of adjuvant radiation therapy (RT) and/or chemotherapy (CT) is controversial. We conducted a National Cancer Data Base (NCDB) analysis to evaluate the survival benefit of adjuvant RT and CT. Materials/Methods: The NCDB was queried for patients with stage I-II clear cell endometrial carcinoma, diagnosed from 1998 through 2011. Patients receiving neoadjuvant therapy, not undergoing surgical staging (total hysterectomy and bilateral salpingo-oopherectomy), or without adjuvant treatment characteristics were excluded. Bivariate regression was conducted to establish factors associated with treatment utilization. Propensity scores were calculated using multivariate logistic regression with forward conditional selection (P<.10) for each treatment approach. Logrank test and multivariate Cox proportional hazards modeling with propensity score adjustment were conducted to identify factors associated with adjuvant RT and CT utilization and their subsequent survival impact. Results: A total of 2078 patients were identified. All patients received surgical staging with confirmed negative regional lymph nodes. Four hundred eight (19.6%) patients received adjuvant CT, and 833 (40.1%) received adjuvant RT. Radiation therapy utilization ranged from 30.745.9% with no significant change over time (PZ.21); RT utilization was higher among patients receiving CT (OR 1.84, P<.001), with FIGO stage II disease (OR 2.12, P<.001), and treated at facilities in the bottom volume quartile (OR 1.81, PZ.003). Radiation therapy was less likely to be delivered to patients living a greater distance from treatment facilities (>30 miles: OR 0.51, P<.001). Computed tomography utilization increased over time from 5.1% in 1998-2003 to 36.3% in 2009-2011 (P<.001); CT utilization was higher for patients receiving RT (OR 2.41, P<.001) and with FIGO stage II disease (OR 2.03, P<.001) and was lower for patients with advanced age (>75 years: OR 0.31, P<.001). With a median follow-up of 71.9 months, the 6-year estimated survival for patients treated with no adjuvant therapy, RT alone, CT alone, and CT+RT were 73.6, 67.4, 66.9, and 76.6%, respectively (PZ.073). Neither delivery of adjuvant RT (HR 1.00, 95% CI 0.72-1.40, PZ.981) nor adjuvant CT (HR 1.11, 95% CI 0.70-1.76, PZ.649) were associated with improved survival. Conclusion: Despite evaluating a favorable subset of patients with an aggressive histologic variant of endometrial cancer, no demonstrated survival impact was seen from adjuvant therapy. The impact of adjuvant therapy on local control and progression-free survival as well as pathologic features such as lymphovascular invasion should be further investigated for these patients, given inability to capture such data in the present analysis. Author Disclosure: K.M. Xu: None. B.S. Gill: None. G. Balasubramani: None. P. Sukumvanich: None. T.C. Krivak: None. S. Beriwal: None.
3214 Proctitis One Week After Stereotactic Body Radiation Therapy for Prostate Cancer: Implications for Clinical Trial Design I. Paydar,1 R.A. Cyr,1 T. Yung,1 S. Lei,2 B.T. Collins,1 L. Chen,1 S. Suy,2 A. Dritschilo,2 J.H. Lynch,1 and S.P. Collins2; 1Georgetown University Medical Center, Washington, DC, 2Georgetown University Hospital, Washington, DC Purpose/Objective(s): Proctitis after radiation therapy for prostate cancer is a primary determinant of quality of life and remains an ongoing clinical challenge. While previous studies have described acute rectal toxicity at 1 month after treatment with SBRT, little data exist on the development of rectal toxicity within the first week of treatment. This study reported the acute bowel morbidity following prostate SBRT from a single institution. Materials/Methods: From May 2013 through August 2014, 103 patients with clinically localized prostate cancer were treated with 35 to 36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4). Bowel quality of life (QOL)
3215 Quality of Life (QOL) Following Sequential Boost Regimen (SB) With Helical Tomotherapy Intensity Modulated Radiation Therapy (HTIMRT) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN): A Prospective Study S. El-Sayed,1 M.Y. Almaghrabi,1 and H. Marginean2; 1University of Ottawa, Ottawa, ON, Canada, 2Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada Purpose/Objective(s): Radiation therapy delivery using IMRT in SCCHN was quickly adopted despite the lack of detailed toxicity data. Randomized data now exists as to the significant impact on the incidence of mucositis. Little data exists as to the impact on quality of life (QOL). This analysis is part of a larger study profiling the toxicity of HTIMRT. The objective of this analysis was to evaluate the impact of HTIMRT on QOL of patients treated for SCCHN and to compare that to what is reported in the literature using 3D conformal XRT. Materials/Methods: This prospective study was carried out from 2006 e 2012; HTIMRT was delivered in 70 Gy in 35 fractions (XRT) of an SB regimen. Patient-rated EORTC QLQ-C30 and EORTC QLQ H&N 35 scores have been collected preradiation therapy, 2/4/6/7/8 weeks during the treatment, and 2/4/6/8/12/24 weeks post radiation therapy. Scoring procedures was done using EORTC QLQ-C30 scoring manual, third edition. Clinically relevant changes were defined as moderate and large changes in quality of life (> 10 scores). Adjustment was performed with pretherapy scores. Results: Quality of life data for 87 evaluable patients were available including pretherapy baseline (BL) questionnaires. Forty-eight percent received concomitant chemotherapy (CRT). For EORTC QLQ-C30 module, the impact of HTIMRT during radiation therapy was large (>20 scores) at fourth week (on role functioning, appetite loss, and constipation subscales) and sixth week (on global QOL, social functioning, fatigue, nausea/vomiting, and pain subscales). Significant posttreatment recovery (>10 improved scores) occurred at 2 weeks (for appetite loss subscales), 4 weeks (for social functioning, fatigue, pain, and constipation subscales), and 6 weeks (for global QOL, physical functioning, cognitive functioning, role functioning, and nausea/vomiting subscales). Global QOL improved to a level above BL by 24 weeks. All subscales return to BL values except for role functioning, appetite loss, and financial difficulty subscales. Disease-specific problems measured by EORTC QLQ H&N 35 divulged the most unpleasant scores. Symptoms such as swallowing, senses, social eating, sexuality, dry mouth, sticky saliva, nutritional supplement, and