- Email: [email protected]
Chinese Medicinal Formulas as Retention Enemas in Patients With Radiation Proctitis: A Multicenter Retrospective Survey
E198
International Journal of Radiation Oncology Biology Physics
to the planning target volume (PTV) with a median of 54 Gy/1.8-2.0Gy fraction. The boost dose was given to the primary tumor and metastatic regional lymph nodes to a median total dose of 61.5Gy/2.0-2.3Gy fraction. For patients with conventional fractionated radiotherapy (CFR), PTV was prescribed to 60Gy/1.8-2.0Gy fraction. A propensity score matching (PSM) method (1:1 for SIB-IMRT vs CFR) was used to identify 932 wellbalanced patients for validation studies. Actuarial survival was calculated with the Kaplan-Meier method, and univariate comparison between groups was performed by using the log-rank test. Cox regression served as a multivariate technique using a backward elimination model for all covariates. Results: Median age was 64 years, and most patients were male (72.7 %). Primary tumor location in cervical, upper, middle and lower of esophagus were determined in 6%, 35%, 48% and 12%. The patients were clinically staged as stage IIa/b (22%), III (56%), and IVa/b (without visceral metastasis or positive lymph node out of regional site) (22%), according to AJCC 6th TNM classification. After PSM, the 2-year overall survival (OS) and median survival were 51.5% and 28 months in SIB-IMRT group, which is significantly higher than that in CFR group (46.5% and 24 months, P<0.001). In the multivariate survival analysis, clinical stage (Hazard Ratio [HR]: 1.53, 95% CI: 1.38-1.97, P < 0.001), tumor length (HR: 1.05, 95% CI: 1.02-1.08, P Z 0.001), female (HR: 0.81, 95% CI: 0.69-0.95, P Z 0.011), concurrent chemoradiotherapy (HR: 0.76, 95% CI: 0.67-0.88, P < 0.001) and SIB-IMRT (HR: 0.89, 95% CI: 0.77-0.97, P Z 0.034) were independent prognostic factors. Subgroup analysis suggested patients with age 70, upper 1/3 esophageal cancer, tumor length 5cm, and cN0 stage tumors were more likely to demonstrate survival benefit from SIB-IMRT. Conclusion: Compared with CFR, SIB-IMRT may provide a survival benefit to LESCC patients. A prospective study is needed to verify our findings and to provide scientific evidence for this subject. Author Disclosure: X. Wang: None. J. Chen: None. W. Zhang: None. Q. Yuan: None. X. Wang: None. Y. Xu: None. N. Lu: None. Q. Pang: None. K. Zhang: None. C. Hao: None. Y. Wang: None. W. Deng: None. W. Ni: None. C. Li: None. X. Chang: None. L. Deng: None. W. Wang: None. J. Liang: None. Z. Xiao: None. Y. Zhao: None. G. Li: None. Z.g. Zhou: None. X. Qiao: None. S. Qie: None. M. Liu: None.
NACT alone, while 37 (BRZ19, URZ18) received CRT. For the NACT alone group, T- and N-stages were 57.1% T3, 42.9% T4, 53.6% N0, and 46.4% N1. NACT was FOLFIRINOX (39.3%) or gemcitabine-based (60.7%), with a median of 4 cycles. RR for the NACT cohort was 60.7% (BRZ13, URZ4), with R0 in 13 (BRZ10, URZ3) and R1 in 4 (BRZ3, URZ1). Median OS for the R0 and R1 groups were 16.5 and 8 months, respectively. Eleven (BRZ3, URZ8) did not undergo resection due to disease progression and/or were deemed medically inoperable. After NACT, 37 patients remained unresectable (BRZ19, URZ18) and subsequently received CRT. T-stages for this cohort were 2.6% T1, 2.6% T2, 34.2% T3, and 60.6% T4. N-stages were 63.1% N0 and 36.9% N1. NACT was FOFIRINOX (43.2%) or gemcitabine-based (48.6%), with a median of 4 cycles. CRT was predominantly 5-FU-based (94.6%). Radiation utilized IMRT, the PTV encompassed the primary tumor and vasculature involved, and was to a median dose of 50.4Gy in 18 fractions (BED of 63.1Gy). RR for the CRT cohort was 37.8%, with R0 in 11 (BRZ5, URZ6) and R1 in 3 (BRZ2, URZ1). Median OS for R0 and R1 groups were 17 and 8 months, respectively. Twenty-three patients remained unresectable (BRZ12, URZ11). Median OS for non-surgical patients was 7.5 months, and no late Grade 3 or 4 toxicities were reported. At the time of this analysis, 11 (40.7%) patients from the NACT cohort were alive and 8 (28.6%) declared NED. For the CRT cohort, 12 (32.4%) patients were alive and 7 (18.9%) declared NED. Conclusion: This study shows the addition of neoadjuvant CRT can improve RR and OS in patients with BR/UR pancreatic cancer and approximates the outcomes of patients with upfront resectable disease. CRT after NACT is well-tolerated and should be considered in non-responders suitable for curative-intent surgery. Author Disclosure: J.S. Weir: None. K. McLean: None. C. Henson: None. J. Morton: None. S. Pant: None. S. George: None. R. Aljumaily: None. R. Postier: None. T.S. Herman: None.
2475 Efficacy of Chemoradiation in Locally Advanced (Borderline Resectable and Unresectable) Pancreatic Cancer Remaining Unresectable After Neoadjuvant Chemotherapy J.S. Weir,1 K. McLean,1 C. Henson,1 J. Morton,2 S. Pant,2 S. George,2 R. Aljumaily,2 R. Postier,3 and T.S. Herman1,2; 1University of Oklahoma Health Science Center, Stephenson Cancer Center, Department of Radiation Oncology, Oklahoma City, OK, 2University of Oklahoma Health Science Center, Stephenson Cancer Center, Department of Hematology & Oncology, Oklahoma City, OK, 3University of Oklahoma Health Science Center, Department of Surgery, Oklahoma City, OK Purpose/Objective(s): Pancreatic cancer is largely borderline resectable (BR) or unresectable (UR) at time of diagnosis (80%). Surgery remains the only curative option, but only a small percentage (20-30%) undergoes resection. Neoadjuvant treatments aim to improve resection rates, but consensus guidelines have yet to be established. Our aim is to evaluate the efficacy of chemoradiation (CRT) following neoadjuvant chemotherapy (NACT) in patients with BR/UR remaining unresectable after NACT. Materials/Methods: Retrospective chart review was completed for patients with BR/UR who underwent NACT (2008-2016). Resectability was determined by initial imaging with CT per pancreatic protocol and/or PET/ CT. All patients received NACT, repeated imaging, and were reviewed by our multidisciplinary tumor board to determine resectability or further neoadjuvant therapy with CRT. Primary endpoints include resectability rate (RR) and overall survival (OS). Results: Sixty-five patients were eligible, 35 BR and 30 UR. Median F/U was 13.5 months. Twenty-eight (BRZ16, URZ12) patients received
2476 Chinese Medicinal Formulas as Retention Enemas in Patients With Radiation Proctitis: A Multicenter Retrospective Survey W. He,1 X. LIU,2 O. Jiang,3 K. LEI,4 Q. Zhou,2 L. WANG,5 X. Chen,4 R. Ding,1 and Q. Wen1; 1Department of Oncology, the Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China, 2Department of Oncology, Suining Central Hospital, Suining, Sichuan, China, 3The Second People’s Hospital of Neijiang, Neijiang, Sichuan, China, 4Department of Oncology, the Second People’s Hospital of Yibin, Yibin, Sichuan, China, 5 Department of Oncology, Zigong First People’s Hospital, Zigong, Sichuan, China Purpose/Objective(s): This study aimed to assess whether Chinese medicinal formulas as retention enemas could effectively treat radiation proctitis following radiotherapy in patients with pelvic malignant disease. Materials/Methods: This study was an open-label, retrospective, multicenter study of patients with radiation proctitis treated with Chinese medicinal formulas as retention enemas. The diagnosis adhered to the Diagnostic Criteria for Radiation Proctitis (GBZ 111-2002). The degree of radiation proctitis was classified into a graded system devised by Radiation Therapy Oncology Group (RTOG). Retrospective data were collected from patients’ medical records in 5 hospitals for the 2011-2016 period. Patient follow-up was conducted via outpatient service and telephone. The patients were divided into 3 treatments based on the ingredient present in the Chinese medicinal formulas, as follows: Treatment A (intestinal mucosa protector, symptomatic treatment), Treatment B (symptomatic treatment), and Treatment C (Chinese Medicinal Formulae, symptomatic treatment). Data were analyzed using SPSS ver. 20.0, and quantitative data were summarized using meanstandard deviation. Comparison of treatments was conducted using analysis of variance (one-way ANOVA). Qualitative data were analyzed using the chi-square test or Fisher’s exact probabilities test. PÓ,0.05 was considered statistically significant. Results: A total of 1463 patients who received pelvic radiotherapy were reviewed in our study. The incidence rate of radiation proctitis was
Volume 99 Number 2S Supplement 2017 10.1% (nZ148), consisting of acute radiation proctitis (ARP) and chronic radiation proctitis (CRP) at 5.6% (nZ83) and 5.1% (nZ75), respectively. The retention enema was used in 105 cases of patients with radiation proctitis, including ARP (nZ49) and CRP (nZ56). The patients mostly experienced RTOG acute grade 1 (nZ34) or 2 (nZ15), or chronic grade 1 (nZ35) to 2 (nZ21) toxicities. Most patients suffered from diarrhea, bleeding, pain, and tenesmus. The symptoms were partially or completely improved in 85.7% of patients with ARP after therapy. The response rates of ARP administered with Treatments A, B, and C, were 70.6%, 90.5%, and 100%, respectively.Approximately 69.6% of patients with CRP exhibited partial to good response after retention enema. The response rates of CRP administered with Treatments A, B, and C, were 46.1%, 66.6%, and 84%, respectively. The response of grade-1 CRP to Treatment C (93.3%) was better than its response to Treatments A (50%) and B (70%). Kangfuxin (nZ34) and Xilei powder (nZ33) were the most common intestinal mucosa protective agent and Chinese Medicinal Formulae in the treatment of radiation proctitis in Groups A and C, respectively. Conclusion: Kangfuxin and Xilei powder in Chinese medicinal formulas used as retention enemas may significantly improve the clinical symptoms of patients with radiation proctitis. In particular, Xilei powder for grade-1 CRP exhibited an obvious effect. Author Disclosure: W. He: None. X. LIU: None. O. Jiang: None. K. LEI: None. Q. Zhou: None. L. WANG: None. X. Chen: None. R. Ding: None. Q. Wen: None.
2477 Lymphocyte-Sparing Effect of Stereotactic Body Radiation Therapy Compared to Conventional Fractionated Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer G. Wu,1 N. Zhao,2 S. Li,3 M. Baine,3 and C. Lin3; 1Department of Radiation Oncology Henan Provincial People’s Hospital, Zhenzhou, China, 2Medical Sciences Interdepartmental Area, University of Nebraska Medical Center, Omaha, NE, 3Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, NE Purpose/Objective(s): Conventional fractionated radiation therapy (CFRT)-induced lymphopenia has been reported to be associated with compromised survival in patients with glioblastoma, lung cancer, and pancreatic cancer. However, it is unknown if stereotactic body radiation therapy (SBRT) will induce lymphopenia and its relationship with survival outcomes. Due to smaller fields and a faster dose fall off of SBRT, we hypothesize that SBRT will induce less lymphopenia when compared to CFRT, which may lead to improved survival outcomes on patients with locally advanced pancreatic adenocarcinoma. Materials/Methods: Medical records of patients with locally advanced pancreatic adenocarcinoma treated at UNMC with neoadjuvant or definitive CFRT or SBRT following induction chemotherapy from 2004-2016 were reviewed. Patients who had baseline and follow-up total lymphocyte counts (TLCs) measured at our institution were included in this study. Patients were stratified into 4 groups: 1) CFRT/5-fluorouracil (5FU), 2) SBRT/5FU, 3) SBRT/Nelfinavir (NVF) and 4) SBRT alone. Median CFRT and SBRT prescription doses were 50.4 Gy (range 8 e 50.4 Gy) at 1.8-2 Gy per fraction and 35 Gy (range 25 - 40 Gy) in 5 fractions, respectively. Serial TLCs from day 0 (the first day of RT) to 40 were recorded. Multiple comparisons were performed using the KruskaleWallis test and P values were adjusted with Bonferroni method. Linear regression was used to estimate the slope of TLCs change with time. The Kaplan-Meier plot was used for survival analysis. Results: Among 103 patients identified, 28 were treated with CFRT/5FU, 17 SBRT/5FU, 46 SBRT/NVF and 12 SBRT alone. The median pre-RT baseline TLCs were 1.5 (range 0.5-2.8), 1 (range 0.4-3.3), 1.2 (range 0.32.6) and 1.5 (range 0.7-2.3) cells/mm3, respectively. There was no difference in median baseline TLCs among 4 groups (p > 0.05). The median slopes of TLCs changed from day 0 to 40 after starting radiation and were
Poster Viewing E199 increasing in the following sequence: CFRT/5FU (-0.0239) < SBRT/5FU (-0.0042) < SBRT/NFV (-0.0016) < SBRT alone (0.0024). The median lowest TLCs were 0.2 (range 0-1.6), 0.4 (range 0.1-1.5), 0.7 (range 0-1.6) and 1.1 (range 0.3-1.5) cells/mm3, respectively. CFRT patients had significantly lower lowest TLCs than all SBRT subgroups (P <0.001). The median time to lowest TLCs were 30, 26, 28 and 23 days, respectively. There was no difference in time to lowest TLCs among groups (P >0.05). Survival analysis revealed no significant difference in median overall survival among all groups. Conclusion: SBRT is associated with significant less treatment-induced lymphopenia than CFRT. This did not translate into survival benefit. Further study of the effect of radiation technique on immune status is warranted. Author Disclosure: G. Wu: None. N. Zhao: None. S. Li: None. M. Baine: None. C. Lin: Research Grant; DHHS/NIH/NCI, Eppley Cancer center at UNMC, Quest Pharma Tech, Inc.. To purchase a research drug; Eppley Cancer center at UNMC. Focus is on translational studies that address basic and clinical issues of importance to improving outcome of patients with pancreatic cancer. Role: Project Leader Title of the project: Novel Tar.
2478 Phase 2 Study of Intensity-Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma K. Wu, H. Wang, and X. Fan; Fudan University Shanghai Cancer Center, shanghai, China Purpose/Objective(s): The treatment of locally advanced esophageal carcinoma remains a great challenge. For patients who are not surgical candidates, the majority of them are managed primarily with chemoradiation. However, radiation dose has been controversial. A prospective phase II study (ChiCTR-OIC-17010485) was conducted to determine the tolerance and efficacy of high dose intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy for inoperable locally advanced esophageal squamous cell carcinoma (SCC). Materials/Methods: Eligibility criteria were: (1) histologically or cytologically proven esophageal SCC; (2) age 18-80 years; (3) Karnofsky performance status (KPS) 70; (4) clinical stages of I-IVA (AJCC,2002) with disease unresectable or inoperable, or the refusal of surgery; (5) no chemotherapy or surgery before enrollment; (6) normal liver, kidney and bone marrow functions; (7) no previous cancer history. Patients underwent IMRT for thoracic esophageal SCC. PTV1 composed of a 1.2-1.5 cm margin lateral around GTV and 3.0 cm margin superior/inferior of GTV. PTV2 encompassed GTV with a margin of 0.5-0.7 cm. The dose for PTV1 was 50 Gy in 2 Gy daily fractions; subsequently, PTV2 received a boost of 16 Gy in 2 Gy daily fractions to a total dose of 66 Gy. The concurrent chemotherapy regiments were fluorouracil (600mg/m2,d1-3) combined ciplatin (25mg/m2, d1-3) with 2 cycles and consolidate chemotherapy 2 cycles. Results: A total of 86 patients were included with a median age of 64 years. The number of patients with stage I, II,III,IVA were 1,20,37 and 28, respectively. The median follow-up time was 19 months. None experienced CTCAE grade 4. The hematological toxicity with CTCAE grade 1,2,3 was 19%, 48.1% and 22.8%. The acute radiation esophagitis developed in 70% of patients with RTOG grades 1-2,and in 3.8% with grade 3. RTOG 1-2 radiation pneumonitis occurred in 20.8% of patients and in 1.3% with grade III. The rate of two-year overall survival, progression-free survival, distant metastasis and local control were 62.3%,35.5%,52.8% and 48.9%, respectively. Conclusion: Patients with inoperable locally advanced esophageal cancer received high dose of 66Gy IMRT with concurrent chemotherapy had a good tolerance and two-year overall survival was 62.3%. We warrant further studies evaluating the effectiveness of this approach compared with standard dose of 50.4Gy and chemotherapy. Author Disclosure: K. Wu: None. H. Wang: None. X. Fan: None.
International Journal of Radiation Oncology Biology Physics
to the planning target volume (PTV) with a median of 54 Gy/1.8-2.0Gy fraction. The boost dose was given to the primary tumor and metastatic regional lymph nodes to a median total dose of 61.5Gy/2.0-2.3Gy fraction. For patients with conventional fractionated radiotherapy (CFR), PTV was prescribed to 60Gy/1.8-2.0Gy fraction. A propensity score matching (PSM) method (1:1 for SIB-IMRT vs CFR) was used to identify 932 wellbalanced patients for validation studies. Actuarial survival was calculated with the Kaplan-Meier method, and univariate comparison between groups was performed by using the log-rank test. Cox regression served as a multivariate technique using a backward elimination model for all covariates. Results: Median age was 64 years, and most patients were male (72.7 %). Primary tumor location in cervical, upper, middle and lower of esophagus were determined in 6%, 35%, 48% and 12%. The patients were clinically staged as stage IIa/b (22%), III (56%), and IVa/b (without visceral metastasis or positive lymph node out of regional site) (22%), according to AJCC 6th TNM classification. After PSM, the 2-year overall survival (OS) and median survival were 51.5% and 28 months in SIB-IMRT group, which is significantly higher than that in CFR group (46.5% and 24 months, P<0.001). In the multivariate survival analysis, clinical stage (Hazard Ratio [HR]: 1.53, 95% CI: 1.38-1.97, P < 0.001), tumor length (HR: 1.05, 95% CI: 1.02-1.08, P Z 0.001), female (HR: 0.81, 95% CI: 0.69-0.95, P Z 0.011), concurrent chemoradiotherapy (HR: 0.76, 95% CI: 0.67-0.88, P < 0.001) and SIB-IMRT (HR: 0.89, 95% CI: 0.77-0.97, P Z 0.034) were independent prognostic factors. Subgroup analysis suggested patients with age 70, upper 1/3 esophageal cancer, tumor length 5cm, and cN0 stage tumors were more likely to demonstrate survival benefit from SIB-IMRT. Conclusion: Compared with CFR, SIB-IMRT may provide a survival benefit to LESCC patients. A prospective study is needed to verify our findings and to provide scientific evidence for this subject. Author Disclosure: X. Wang: None. J. Chen: None. W. Zhang: None. Q. Yuan: None. X. Wang: None. Y. Xu: None. N. Lu: None. Q. Pang: None. K. Zhang: None. C. Hao: None. Y. Wang: None. W. Deng: None. W. Ni: None. C. Li: None. X. Chang: None. L. Deng: None. W. Wang: None. J. Liang: None. Z. Xiao: None. Y. Zhao: None. G. Li: None. Z.g. Zhou: None. X. Qiao: None. S. Qie: None. M. Liu: None.
NACT alone, while 37 (BRZ19, URZ18) received CRT. For the NACT alone group, T- and N-stages were 57.1% T3, 42.9% T4, 53.6% N0, and 46.4% N1. NACT was FOLFIRINOX (39.3%) or gemcitabine-based (60.7%), with a median of 4 cycles. RR for the NACT cohort was 60.7% (BRZ13, URZ4), with R0 in 13 (BRZ10, URZ3) and R1 in 4 (BRZ3, URZ1). Median OS for the R0 and R1 groups were 16.5 and 8 months, respectively. Eleven (BRZ3, URZ8) did not undergo resection due to disease progression and/or were deemed medically inoperable. After NACT, 37 patients remained unresectable (BRZ19, URZ18) and subsequently received CRT. T-stages for this cohort were 2.6% T1, 2.6% T2, 34.2% T3, and 60.6% T4. N-stages were 63.1% N0 and 36.9% N1. NACT was FOFIRINOX (43.2%) or gemcitabine-based (48.6%), with a median of 4 cycles. CRT was predominantly 5-FU-based (94.6%). Radiation utilized IMRT, the PTV encompassed the primary tumor and vasculature involved, and was to a median dose of 50.4Gy in 18 fractions (BED of 63.1Gy). RR for the CRT cohort was 37.8%, with R0 in 11 (BRZ5, URZ6) and R1 in 3 (BRZ2, URZ1). Median OS for R0 and R1 groups were 17 and 8 months, respectively. Twenty-three patients remained unresectable (BRZ12, URZ11). Median OS for non-surgical patients was 7.5 months, and no late Grade 3 or 4 toxicities were reported. At the time of this analysis, 11 (40.7%) patients from the NACT cohort were alive and 8 (28.6%) declared NED. For the CRT cohort, 12 (32.4%) patients were alive and 7 (18.9%) declared NED. Conclusion: This study shows the addition of neoadjuvant CRT can improve RR and OS in patients with BR/UR pancreatic cancer and approximates the outcomes of patients with upfront resectable disease. CRT after NACT is well-tolerated and should be considered in non-responders suitable for curative-intent surgery. Author Disclosure: J.S. Weir: None. K. McLean: None. C. Henson: None. J. Morton: None. S. Pant: None. S. George: None. R. Aljumaily: None. R. Postier: None. T.S. Herman: None.
2475 Efficacy of Chemoradiation in Locally Advanced (Borderline Resectable and Unresectable) Pancreatic Cancer Remaining Unresectable After Neoadjuvant Chemotherapy J.S. Weir,1 K. McLean,1 C. Henson,1 J. Morton,2 S. Pant,2 S. George,2 R. Aljumaily,2 R. Postier,3 and T.S. Herman1,2; 1University of Oklahoma Health Science Center, Stephenson Cancer Center, Department of Radiation Oncology, Oklahoma City, OK, 2University of Oklahoma Health Science Center, Stephenson Cancer Center, Department of Hematology & Oncology, Oklahoma City, OK, 3University of Oklahoma Health Science Center, Department of Surgery, Oklahoma City, OK Purpose/Objective(s): Pancreatic cancer is largely borderline resectable (BR) or unresectable (UR) at time of diagnosis (80%). Surgery remains the only curative option, but only a small percentage (20-30%) undergoes resection. Neoadjuvant treatments aim to improve resection rates, but consensus guidelines have yet to be established. Our aim is to evaluate the efficacy of chemoradiation (CRT) following neoadjuvant chemotherapy (NACT) in patients with BR/UR remaining unresectable after NACT. Materials/Methods: Retrospective chart review was completed for patients with BR/UR who underwent NACT (2008-2016). Resectability was determined by initial imaging with CT per pancreatic protocol and/or PET/ CT. All patients received NACT, repeated imaging, and were reviewed by our multidisciplinary tumor board to determine resectability or further neoadjuvant therapy with CRT. Primary endpoints include resectability rate (RR) and overall survival (OS). Results: Sixty-five patients were eligible, 35 BR and 30 UR. Median F/U was 13.5 months. Twenty-eight (BRZ16, URZ12) patients received
2476 Chinese Medicinal Formulas as Retention Enemas in Patients With Radiation Proctitis: A Multicenter Retrospective Survey W. He,1 X. LIU,2 O. Jiang,3 K. LEI,4 Q. Zhou,2 L. WANG,5 X. Chen,4 R. Ding,1 and Q. Wen1; 1Department of Oncology, the Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China, 2Department of Oncology, Suining Central Hospital, Suining, Sichuan, China, 3The Second People’s Hospital of Neijiang, Neijiang, Sichuan, China, 4Department of Oncology, the Second People’s Hospital of Yibin, Yibin, Sichuan, China, 5 Department of Oncology, Zigong First People’s Hospital, Zigong, Sichuan, China Purpose/Objective(s): This study aimed to assess whether Chinese medicinal formulas as retention enemas could effectively treat radiation proctitis following radiotherapy in patients with pelvic malignant disease. Materials/Methods: This study was an open-label, retrospective, multicenter study of patients with radiation proctitis treated with Chinese medicinal formulas as retention enemas. The diagnosis adhered to the Diagnostic Criteria for Radiation Proctitis (GBZ 111-2002). The degree of radiation proctitis was classified into a graded system devised by Radiation Therapy Oncology Group (RTOG). Retrospective data were collected from patients’ medical records in 5 hospitals for the 2011-2016 period. Patient follow-up was conducted via outpatient service and telephone. The patients were divided into 3 treatments based on the ingredient present in the Chinese medicinal formulas, as follows: Treatment A (intestinal mucosa protector, symptomatic treatment), Treatment B (symptomatic treatment), and Treatment C (Chinese Medicinal Formulae, symptomatic treatment). Data were analyzed using SPSS ver. 20.0, and quantitative data were summarized using meanstandard deviation. Comparison of treatments was conducted using analysis of variance (one-way ANOVA). Qualitative data were analyzed using the chi-square test or Fisher’s exact probabilities test. PÓ,0.05 was considered statistically significant. Results: A total of 1463 patients who received pelvic radiotherapy were reviewed in our study. The incidence rate of radiation proctitis was
Volume 99 Number 2S Supplement 2017 10.1% (nZ148), consisting of acute radiation proctitis (ARP) and chronic radiation proctitis (CRP) at 5.6% (nZ83) and 5.1% (nZ75), respectively. The retention enema was used in 105 cases of patients with radiation proctitis, including ARP (nZ49) and CRP (nZ56). The patients mostly experienced RTOG acute grade 1 (nZ34) or 2 (nZ15), or chronic grade 1 (nZ35) to 2 (nZ21) toxicities. Most patients suffered from diarrhea, bleeding, pain, and tenesmus. The symptoms were partially or completely improved in 85.7% of patients with ARP after therapy. The response rates of ARP administered with Treatments A, B, and C, were 70.6%, 90.5%, and 100%, respectively.Approximately 69.6% of patients with CRP exhibited partial to good response after retention enema. The response rates of CRP administered with Treatments A, B, and C, were 46.1%, 66.6%, and 84%, respectively. The response of grade-1 CRP to Treatment C (93.3%) was better than its response to Treatments A (50%) and B (70%). Kangfuxin (nZ34) and Xilei powder (nZ33) were the most common intestinal mucosa protective agent and Chinese Medicinal Formulae in the treatment of radiation proctitis in Groups A and C, respectively. Conclusion: Kangfuxin and Xilei powder in Chinese medicinal formulas used as retention enemas may significantly improve the clinical symptoms of patients with radiation proctitis. In particular, Xilei powder for grade-1 CRP exhibited an obvious effect. Author Disclosure: W. He: None. X. LIU: None. O. Jiang: None. K. LEI: None. Q. Zhou: None. L. WANG: None. X. Chen: None. R. Ding: None. Q. Wen: None.
2477 Lymphocyte-Sparing Effect of Stereotactic Body Radiation Therapy Compared to Conventional Fractionated Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer G. Wu,1 N. Zhao,2 S. Li,3 M. Baine,3 and C. Lin3; 1Department of Radiation Oncology Henan Provincial People’s Hospital, Zhenzhou, China, 2Medical Sciences Interdepartmental Area, University of Nebraska Medical Center, Omaha, NE, 3Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, NE Purpose/Objective(s): Conventional fractionated radiation therapy (CFRT)-induced lymphopenia has been reported to be associated with compromised survival in patients with glioblastoma, lung cancer, and pancreatic cancer. However, it is unknown if stereotactic body radiation therapy (SBRT) will induce lymphopenia and its relationship with survival outcomes. Due to smaller fields and a faster dose fall off of SBRT, we hypothesize that SBRT will induce less lymphopenia when compared to CFRT, which may lead to improved survival outcomes on patients with locally advanced pancreatic adenocarcinoma. Materials/Methods: Medical records of patients with locally advanced pancreatic adenocarcinoma treated at UNMC with neoadjuvant or definitive CFRT or SBRT following induction chemotherapy from 2004-2016 were reviewed. Patients who had baseline and follow-up total lymphocyte counts (TLCs) measured at our institution were included in this study. Patients were stratified into 4 groups: 1) CFRT/5-fluorouracil (5FU), 2) SBRT/5FU, 3) SBRT/Nelfinavir (NVF) and 4) SBRT alone. Median CFRT and SBRT prescription doses were 50.4 Gy (range 8 e 50.4 Gy) at 1.8-2 Gy per fraction and 35 Gy (range 25 - 40 Gy) in 5 fractions, respectively. Serial TLCs from day 0 (the first day of RT) to 40 were recorded. Multiple comparisons were performed using the KruskaleWallis test and P values were adjusted with Bonferroni method. Linear regression was used to estimate the slope of TLCs change with time. The Kaplan-Meier plot was used for survival analysis. Results: Among 103 patients identified, 28 were treated with CFRT/5FU, 17 SBRT/5FU, 46 SBRT/NVF and 12 SBRT alone. The median pre-RT baseline TLCs were 1.5 (range 0.5-2.8), 1 (range 0.4-3.3), 1.2 (range 0.32.6) and 1.5 (range 0.7-2.3) cells/mm3, respectively. There was no difference in median baseline TLCs among 4 groups (p > 0.05). The median slopes of TLCs changed from day 0 to 40 after starting radiation and were
Poster Viewing E199 increasing in the following sequence: CFRT/5FU (-0.0239) < SBRT/5FU (-0.0042) < SBRT/NFV (-0.0016) < SBRT alone (0.0024). The median lowest TLCs were 0.2 (range 0-1.6), 0.4 (range 0.1-1.5), 0.7 (range 0-1.6) and 1.1 (range 0.3-1.5) cells/mm3, respectively. CFRT patients had significantly lower lowest TLCs than all SBRT subgroups (P <0.001). The median time to lowest TLCs were 30, 26, 28 and 23 days, respectively. There was no difference in time to lowest TLCs among groups (P >0.05). Survival analysis revealed no significant difference in median overall survival among all groups. Conclusion: SBRT is associated with significant less treatment-induced lymphopenia than CFRT. This did not translate into survival benefit. Further study of the effect of radiation technique on immune status is warranted. Author Disclosure: G. Wu: None. N. Zhao: None. S. Li: None. M. Baine: None. C. Lin: Research Grant; DHHS/NIH/NCI, Eppley Cancer center at UNMC, Quest Pharma Tech, Inc.. To purchase a research drug; Eppley Cancer center at UNMC. Focus is on translational studies that address basic and clinical issues of importance to improving outcome of patients with pancreatic cancer. Role: Project Leader Title of the project: Novel Tar.
2478 Phase 2 Study of Intensity-Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma K. Wu, H. Wang, and X. Fan; Fudan University Shanghai Cancer Center, shanghai, China Purpose/Objective(s): The treatment of locally advanced esophageal carcinoma remains a great challenge. For patients who are not surgical candidates, the majority of them are managed primarily with chemoradiation. However, radiation dose has been controversial. A prospective phase II study (ChiCTR-OIC-17010485) was conducted to determine the tolerance and efficacy of high dose intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy for inoperable locally advanced esophageal squamous cell carcinoma (SCC). Materials/Methods: Eligibility criteria were: (1) histologically or cytologically proven esophageal SCC; (2) age 18-80 years; (3) Karnofsky performance status (KPS) 70; (4) clinical stages of I-IVA (AJCC,2002) with disease unresectable or inoperable, or the refusal of surgery; (5) no chemotherapy or surgery before enrollment; (6) normal liver, kidney and bone marrow functions; (7) no previous cancer history. Patients underwent IMRT for thoracic esophageal SCC. PTV1 composed of a 1.2-1.5 cm margin lateral around GTV and 3.0 cm margin superior/inferior of GTV. PTV2 encompassed GTV with a margin of 0.5-0.7 cm. The dose for PTV1 was 50 Gy in 2 Gy daily fractions; subsequently, PTV2 received a boost of 16 Gy in 2 Gy daily fractions to a total dose of 66 Gy. The concurrent chemotherapy regiments were fluorouracil (600mg/m2,d1-3) combined ciplatin (25mg/m2, d1-3) with 2 cycles and consolidate chemotherapy 2 cycles. Results: A total of 86 patients were included with a median age of 64 years. The number of patients with stage I, II,III,IVA were 1,20,37 and 28, respectively. The median follow-up time was 19 months. None experienced CTCAE grade 4. The hematological toxicity with CTCAE grade 1,2,3 was 19%, 48.1% and 22.8%. The acute radiation esophagitis developed in 70% of patients with RTOG grades 1-2,and in 3.8% with grade 3. RTOG 1-2 radiation pneumonitis occurred in 20.8% of patients and in 1.3% with grade III. The rate of two-year overall survival, progression-free survival, distant metastasis and local control were 62.3%,35.5%,52.8% and 48.9%, respectively. Conclusion: Patients with inoperable locally advanced esophageal cancer received high dose of 66Gy IMRT with concurrent chemotherapy had a good tolerance and two-year overall survival was 62.3%. We warrant further studies evaluating the effectiveness of this approach compared with standard dose of 50.4Gy and chemotherapy. Author Disclosure: K. Wu: None. H. Wang: None. X. Fan: None.