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Efficacy of Chemoradiation in Locally Advanced (Borderline Resectable and Unresectable) Pancreatic Cancer Remaining Unresectable After Neoadjuvant Chemotherapy
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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
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