- Email: [email protected]
Phase I Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma
E120
International Journal of Radiation Oncology Biology Physics
Author Disclosure: N. Liu: None. X. Chen: None. L. Zhao: None. Y. Sun: None. J. WANG: None. K. Chen: None. P. Wang: None.
chemotherapy. Data recorded included details of treatment, toxicities, disease progression, and whether a colostomy was required during the follow-up period. Overall (OS), progression-free (PFS), and colostomyfree (CFS) survival were calculated with Kaplan-Meier methods. Results: The mean age was 63.7 years (range 33-98 years), 65% of the patients were female. The mean follow-up was 26 months (range 3 to 212.8 months). Most patients (90%) presented with a squamous cell histology. 15% of patients had T1 tumors, 50% T2 tumors, 30% T3, 5% T4. The mean tumor size was 3.6 cm. Lymph nodes were thought to be positive in 16% of patients. 169 patients (60%) received IMRT, and 112 patients (40,%) received 3DCRT. The median total tumor dose was 54 Gy (25 to 69.6 Gy). Most patients (80%) experienced acute complications, and 56 % required a treatment break. The IMRT group had fewer and shorter treatment breaks (48% vs 65%)(p Z0.0261) 19% of patients experienced late complications. Patients who received IMRT had a high significant reduction in all grade 3 acute toxicities versus grade 2 toxicities with respect to skin, hematological and GI symptoms and late GI toxicity, as compared to those treated with 3DCRT. The 3-year OS, PFS and CFS were 68, 78, and 91%, respectively. A univariate analysis showed that performance status, gender, dose and t-stage were statistically significant for OS. Performance status, t-stage, and treatment break predicted for PFS. There were no statistically significant predictors for CFS. On multivariate analysis, t-stage and performance status were significant of OS, t-stage, performance status and age for PFS, and no variable predicted for CFS. Conclusion: The present report represents one of the largest series directly comparing 3DCRT and IMRT for definitive treatment of anal cancer. Longterm outcomes did not significantly differ based on RT technique. IMRT for anal cancer reduces all grade 3 toxicities and the need for a treatment break compared to 3DCRT. Author Disclosure: G.A. Ferraris: None. M. Diaz Vazquez: None. M. Ferraris: None. S.E. Finkelstein: None. E. Fernandez: None.
2303 Neoadjuvant Versus Adjuvant Treatment of Gastroesophageal Junction Cancer: An Analysis of Data from the Surveillance, Epidemiology, and End Results (SEER) Registry J.A. Miccio,1,2 O.T. Oladeru,1,2 Y. Xue,3 J. Yang,3 H. Yoon,1 S. Ryu,1 and A. Stessin1; 1Stony Brook University, Department of Radiation Oncology, Stony Brook, NY, 2Stony Brook University School of Medicine, Stony Brook, NY, 3Stony Brook University, Department of Preventive Medicine, Stony Brook, NY Purpose/Objective(s): Cancer of the gastroesophageal junction (GEJ) has been rising in incidence in recent years. The role of radiation therapy (RT) in the treatment of GEJ cancer remains unclear, as the largest prospective trials advocating for either adjuvant or neoadjuvant chemoradiation therapy (CRT) combine GEJ cancer with either gastric or esophageal cancer. The aim of the present study was to examine the effect of neoadjuvant versus adjuvant treatment on overall and disease-specific survival for patients with surgically resected cancer of the true GEJ (Siewert type II). Materials/Methods: The Surveillance, Epidemiology, and End Results (SEER) registry database (2001-2011) was queried for cases of surgically resected Siewert type II gastroesophageal junction cancer. The variables obtained for each case include patient demographics (race/ethnicity, sex, age at presentation, year of diagnosis), disease characteristics (histologic grade, surgical stage/extent of disease, nodal status of the disease, presence of distant metastases), and treatment modalities (radiation sequence relative to surgery, type of surgery performed, and type of radiation administered). Patients with metastatic disease, no surgical intervention, and missing data were excluded from the cohort; 1497 patients with resectable GEJ cancer were identified, with 746 receiving adjuvant RT, and 751 receiving neoadjuvant RT. Retrospective analysis was performed with the endpoints of overall and disease-specific survival. Results: Using cox regression and controlling for independent covariates (age, sex, race, stage, grade, histology, and year of diagnosis), we showed that adjuvant RT resulted in significantly lower death risk (hazard ratio [HR], 0.84; 95% confidence interval 0.73-0.97; P-valueZ.0168) and significantly lower disease-specific death risk (HR, 0.84; 95% confidence interval, 0.72-0.97; P-valueZ.0211) Conclusion: This analysis of SEER data showed a survival benefit for the use of adjuvant RT over neoadjuvant RT for the treatment of Siewert type II GEJ cancer. We suggest future prospective studies to compare outcomes of adjuvant versus neoadjuvant treatment for true GEJ cancer. Author Disclosure: J.A. Miccio: None. O.T. Oladeru: None. Y. Xue: None. J. Yang: None. H. Yoon: None. S. Ryu: None. A. Stessin: None.
2304 Anal Cancer: Clinical Outcomes, Toxicities, and Colostomy Free Survival Comparing 3-D Conformal Radiation Therapy (3DCRT) Versus Intensity Modulated Radiation Therapy (IMRT) Techniques G.A. Ferraris,1 M. F. Diaz Vazquez,1 M. Ferraris,1 S.E. Finkelstein,2 and E. Fernandez3; 1Centro Medico Dean Funes, Co´rdoba, Argentina, 2 21st Century Oncology, Scottsdale, AZ, 321st Century Oncology, Fort Lauderdale, FL Purpose/Objective(s): Definitive techniques of chemoradiation for anal cancer, 3DCRT or IMRT result in excellent long- term outcomes as shown in RTOG protocols. Nevertheless, convincing data demonstrating its advantages remains scarce. The goal of contemporary treatment for this disease is cure without the need for a colostomy. We were interested in the outcomes of our patients who were treated in a community-based radiation treatment centers. Materials/Methods: This is a multi-center retrospective review of data in 281 patients who were treated with definitive chemoradiation therapy for locoregional anal carcinoma between 1992 and 2010. All of them were preoperatively assessed by a surgeon. Ninety-five percent underwent
2305 Phase I Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma S. Yu,1 Z. Xiao,2 Z. Zhou,3 H. Zhang,3 C. Dongfu,4 Q. Feng,5 and J. Liang6; 1Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China, 2Cancer Hospital, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China, 3Chinese Academy of Medical Science, Cancer Hospital, Peking Union Medical College, Beijing, China, 4Chinese Academy of Medical Science, Cancer Hospital, Peking Union Medical College Academy of Medical Science, Cancer Hospital, Peking Union Medical College, Beijing, China, 5Cancer Hospital/Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, CA, China, 6Cancer Institute & Hospital Chinese Academy of Medical Sciences, Beijing, China Purpose/Objective(s): To explore the maximum tolerated dose (MTD) and clinical target volume (CTV) of concurrent chemoradiation for thoracic esophageal squamous cell carcinoma with pathologically positive lymph nodes after radical esophagectomy. Materials/Methods: Eligible patients with thoracic esophageal squamous cell carcinoma after radical surgery had positive lymph nodes, and no allergic history. Patients received 5 or 6 weekly cycles of paclitaxel (20, 30, 40 or 50 mg/m2 for Dose Levels 1,2,3 and 4, respectively) and cisplatin (20mg/m2for Dose Levels 1-4) concurrent with continuous course of intensity modulated radiation therapy (54Gy in 30 fractions or 60Gy in 30fractions). The upper borderline of CTV was cricothyroid membrane and the lower borderline was celiac axis. The dose-limiting toxicities (DLT) were defined as Grade 4 leukopenia, Grade 3 thrombocytopenia or anemia, and Grade 3 non-hematologic toxicities. Results: Between July 2007 and December 2011, 33 patients were enrolled in the study. 75% of them were identified as StageT3-4. Median follow-up was 54.1 months. DLTs were observed as a grade 3 weight loss in the 3 patients of 1st level of 60Gy/2.0Gy/30f cohort one of the additional three patients experienced grade 4 leukopenia. In 54Gy/1.8Gy/30f
Volume 93 Number 3S Supplement 2015 cohort, one patient suffered from allergy to paclitaxel, the rest eleven patients completed whole treatment schedule. However, a Grade 4 leukopenia and a Grade 3 thrombocytopenia were observed in the 3 patients of 4th level of 54Gy/1.8Gy/30f cohort. The MTD was 5 or 6 weekly cycles of paclitaxel 40 mg/m2 and cisplatin 20 mg/m2concurrent with 54 Gy of radiation therapy. After that, CTV was adjusted into upper borderline of the first thoracic vertebra to 3cm below tumor bed. No DLT was observed in the 12 patients in 60 Gy/2.0 Gy/30f cohort. One year overall survival was 81.8%. The volume of clinical target and the mean dose of stomach were significantly reduced because of revision (P Z 0.006, P Z 0.015). One patient had abdominal lymph nodes below celiac axis recurrence after target modification. Conclusion: Weekly cycle of paclitaxel and cisplatin was proven to be safe and efficacious with postoperative radiation of suitable extent of CTV for node-positive thoracic esophageal carcinoma. A Phase II study evaluating Dose Level 4 is ongoing. Author Disclosure: S. Yu: None. Z. Xiao: None. Z. Zhou: None. H. Zhang: None. C. Dongfu: None. Q. Feng: None. J. Liang: None.
2306 Comparison of Perioperative Chemotherapy and Adjuvant Chemoradiation in Resected Gastric Cancer C.D. Corso,1 E.H. Wang,1 N.H. Lester-Coll,1 C.E. Rutter,1 D.N. Yeboa,1 B.R. Mancini,1 J.B. Yu,2 K.L. Johung,3 and H.S.M. Park1; 1Yale School of Medicine, New Haven, CT, 2Yale University, New Haven, CT, 3Yale University School of Medicine, New Haven, CT Purpose/Objective(s): The optimal perioperative management strategy for resectable gastric cancer is not well defined. The MAGIC and INT 0116 trials found an overall survival (OS) benefit of perioperative chemotherapy and adjuvant chemoradiation, respectively, over surgery alone. However, these two treatment regimens have not been directly compared in a randomized trial. In this study, we identify demographic and clinical factors associated with the receipt of each treatment and compare OS between the two regimens in a large national cohort. Materials/Methods: Using the National Cancer Data Base, we identified adult patients diagnosed with gastric adenocarcinoma between 2006-2011 who underwent margin-negative gastrectomy with lymph node examination and either (1) multiple courses of multi-agent neoadjuvant and adjuvant chemotherapy (CT) or (2) adjuvant concurrent chemotherapy and radiation therapy to 45 Gy targeted to the stomach or esophagus (CRT). Patients with M1 disease (clinical or pathologic stage) and T1N0 disease (clinical stage for CT and pathologic stage for CRT) were excluded. Multivariable logistic regression was performed to identify factors independently associated with receipt of each regimen. Analysis of OS was planned using the log-rank test and Cox proportional hazards regression. Propensity score matching (PSM) with 1:1 nearest-neighbor matching without replacement was performed using variables found to be significant on logistic regression. Results: We identified 746 patients who met inclusion criteria, among whom 513 (68.8%) received CRT while 233 patients (31.2%) received CT. The median age was 62, and 49.7% were clinically node-positive. Factors associated with receipt of CT on logistic regression included recent year of diagnosis, private insurance status, further travel distance to reporting facility, higher clinical T and N stage, and greater extent of gastrectomy (near-total/total vs. subtotal) (all P<0.001). In the unmatched cohort, there was no significant difference in OS between CT and CRT (3-year OS 60.1% vs. 66.5%, log-rank PZ0.62). Cox regression was not performed since the proportional hazards assumption was violated. PSM identified a matched cohort of 466 patients (233 per group). We identified no significant difference in OS between treatment groups in the matched cohort or in the clinically node-positive subset (both log-rank P>0.1). Conclusion: Perioperative chemotherapy and adjuvant chemoradiation are associated with similar OS in a national cohort of patients with marginnegative resected gastric cancer. These results suggest that both regimens
Poster Viewing Session E121 are reasonable treatment approaches and that further studies are needed to define patients who may benefit from radiation therapy. Author Disclosure: C.D. Corso: None. E.H. Wang: None. N.H. LesterColl: None. C.E. Rutter: None. D.N. Yeboa: None. B.R. Mancini: None. J.B. Yu: Research Grant; 21st Century. K.L. Johung: None. H.S. Park: None.
2307 A Phase II Study of Magnetic Resonance Imaging Guided Hematopoietical Bone Marrow Sparing Intensity Modulated Radiation Therapy With Concurrent Chemotherapy for Gastric Cancer J. Wang,1 Y. Tian,1 Y. Tang,1 X. Wang,1 N. Li,2 H. Ren,1 H. Fang,3 Y. Feng,1 J. Jin,1 S.L. Wang,1 Y. Song,1 Y. Liu,3 W. Wang,1 and Y. Li1; 1 Cancer Hospital & Institute, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 2Cancer Hospital & Institute, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 3Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China Purpose/Objective(s): Both radiation and chemotherapy are myelosuppressive and more than one-half of the body’s hematopoietically active bone marrow (BM) is located in the pelvic bones, thoracic (T) and lumbar vertebra (L) in adults. It is hypothesized that sparing the hematopoietical active bone marrow identified by magnetic resonance (MR) may reduce acute hematologic toxicity (HT) in postoperative gastric cancer patients treated with concurrent chemoradiation therapy. Materials/Methods: A prospective, open-label, single-arm phase II study (Clinicaltrials.gov registration number: NCT 01863420) was conducted in patients with histologically proven adenocarcinoma of the stomach and suitable for postoperative concurrent chemoradiation therapy. All the patients received MR scanning of vertebral body T8-L4 no later than 7 days before computer tomography (CT) simulation (CTsim). Then MR images were fused with CT-sim images. BM in T1weighted images showing a signal intensity equal to or slightly higher than that of muscle were contoured as active BM, which were contoured as an organ at risk in the treatment plan. Dose constraints for active BM were as follows: V5 (volume receiving a dose of 5 Gy or more) <90%, V10<85%, V20<75%, V30<60% and V40<35%. The treatment regimen consisted of 45 Gy of radiation at 1.8 Gy per day, with concurrent daily capecitabine (1600 mg/m2/d) postoperatively. Primary endpoints were hematologic nadirs and highest grade of each HT occurring within 60 days of initiation of chemoradiation therapy. Multivariable linear regression model is used to test to correlation between HT and dose-volume of BM. Results: A total of 25 staged II/III gastric cancer patients were prospectively enrolled. Twenty four patients (96%) had Stage T3-4 disease, and 22 patients (88%) had node-positive disease. The median age of cohort was 53 years (range, 28e73 years). Before concurrent chemoradiation therapy, adjuvant chemotherapy was administered with a mean cycle of 4.3 0.5. Only 4 patients (16%) developed Grade 3-4 HT during treatment, in which 2 (8.0%), 2 (8.0%), and 2 (8.0%) patients experienced acute Grade 3-4 leukopenia, neutropenia and thrombocytopenia, respectively. None of Grade 3-4 anemia happened. Multivariable logistic linear regression revealed BM-V5 (pZ0.03) and BM-V20 (pZ0.002) were significantly associated with decreased white blood cells (WBC) nadirs, BM-V20 (p<0.001) with decreased absolute neutrophil count nadirs, BM-V30 (pZ0.002) and volume of BM (pZ0.001) with decreased platelet count nadirs. Conclusion: Irradiation of active BM identified by MR is associated with HT. Techniques to limit low dose radiation to BM could reduce HT in gastric cancer patients. Author Disclosure: J. Wang: None. Y. Tian: None. Y. Tang: None. X. Wang: None. N. Li: None. H. Ren: None. H. Fang: None. Y. Feng: None. J. Jin: None. S. Wang: None. Y. Song: None. Y. Liu: None. W. Wang: None. Y. Li: None.
International Journal of Radiation Oncology Biology Physics
Author Disclosure: N. Liu: None. X. Chen: None. L. Zhao: None. Y. Sun: None. J. WANG: None. K. Chen: None. P. Wang: None.
chemotherapy. Data recorded included details of treatment, toxicities, disease progression, and whether a colostomy was required during the follow-up period. Overall (OS), progression-free (PFS), and colostomyfree (CFS) survival were calculated with Kaplan-Meier methods. Results: The mean age was 63.7 years (range 33-98 years), 65% of the patients were female. The mean follow-up was 26 months (range 3 to 212.8 months). Most patients (90%) presented with a squamous cell histology. 15% of patients had T1 tumors, 50% T2 tumors, 30% T3, 5% T4. The mean tumor size was 3.6 cm. Lymph nodes were thought to be positive in 16% of patients. 169 patients (60%) received IMRT, and 112 patients (40,%) received 3DCRT. The median total tumor dose was 54 Gy (25 to 69.6 Gy). Most patients (80%) experienced acute complications, and 56 % required a treatment break. The IMRT group had fewer and shorter treatment breaks (48% vs 65%)(p Z0.0261) 19% of patients experienced late complications. Patients who received IMRT had a high significant reduction in all grade 3 acute toxicities versus grade 2 toxicities with respect to skin, hematological and GI symptoms and late GI toxicity, as compared to those treated with 3DCRT. The 3-year OS, PFS and CFS were 68, 78, and 91%, respectively. A univariate analysis showed that performance status, gender, dose and t-stage were statistically significant for OS. Performance status, t-stage, and treatment break predicted for PFS. There were no statistically significant predictors for CFS. On multivariate analysis, t-stage and performance status were significant of OS, t-stage, performance status and age for PFS, and no variable predicted for CFS. Conclusion: The present report represents one of the largest series directly comparing 3DCRT and IMRT for definitive treatment of anal cancer. Longterm outcomes did not significantly differ based on RT technique. IMRT for anal cancer reduces all grade 3 toxicities and the need for a treatment break compared to 3DCRT. Author Disclosure: G.A. Ferraris: None. M. Diaz Vazquez: None. M. Ferraris: None. S.E. Finkelstein: None. E. Fernandez: None.
2303 Neoadjuvant Versus Adjuvant Treatment of Gastroesophageal Junction Cancer: An Analysis of Data from the Surveillance, Epidemiology, and End Results (SEER) Registry J.A. Miccio,1,2 O.T. Oladeru,1,2 Y. Xue,3 J. Yang,3 H. Yoon,1 S. Ryu,1 and A. Stessin1; 1Stony Brook University, Department of Radiation Oncology, Stony Brook, NY, 2Stony Brook University School of Medicine, Stony Brook, NY, 3Stony Brook University, Department of Preventive Medicine, Stony Brook, NY Purpose/Objective(s): Cancer of the gastroesophageal junction (GEJ) has been rising in incidence in recent years. The role of radiation therapy (RT) in the treatment of GEJ cancer remains unclear, as the largest prospective trials advocating for either adjuvant or neoadjuvant chemoradiation therapy (CRT) combine GEJ cancer with either gastric or esophageal cancer. The aim of the present study was to examine the effect of neoadjuvant versus adjuvant treatment on overall and disease-specific survival for patients with surgically resected cancer of the true GEJ (Siewert type II). Materials/Methods: The Surveillance, Epidemiology, and End Results (SEER) registry database (2001-2011) was queried for cases of surgically resected Siewert type II gastroesophageal junction cancer. The variables obtained for each case include patient demographics (race/ethnicity, sex, age at presentation, year of diagnosis), disease characteristics (histologic grade, surgical stage/extent of disease, nodal status of the disease, presence of distant metastases), and treatment modalities (radiation sequence relative to surgery, type of surgery performed, and type of radiation administered). Patients with metastatic disease, no surgical intervention, and missing data were excluded from the cohort; 1497 patients with resectable GEJ cancer were identified, with 746 receiving adjuvant RT, and 751 receiving neoadjuvant RT. Retrospective analysis was performed with the endpoints of overall and disease-specific survival. Results: Using cox regression and controlling for independent covariates (age, sex, race, stage, grade, histology, and year of diagnosis), we showed that adjuvant RT resulted in significantly lower death risk (hazard ratio [HR], 0.84; 95% confidence interval 0.73-0.97; P-valueZ.0168) and significantly lower disease-specific death risk (HR, 0.84; 95% confidence interval, 0.72-0.97; P-valueZ.0211) Conclusion: This analysis of SEER data showed a survival benefit for the use of adjuvant RT over neoadjuvant RT for the treatment of Siewert type II GEJ cancer. We suggest future prospective studies to compare outcomes of adjuvant versus neoadjuvant treatment for true GEJ cancer. Author Disclosure: J.A. Miccio: None. O.T. Oladeru: None. Y. Xue: None. J. Yang: None. H. Yoon: None. S. Ryu: None. A. Stessin: None.
2304 Anal Cancer: Clinical Outcomes, Toxicities, and Colostomy Free Survival Comparing 3-D Conformal Radiation Therapy (3DCRT) Versus Intensity Modulated Radiation Therapy (IMRT) Techniques G.A. Ferraris,1 M. F. Diaz Vazquez,1 M. Ferraris,1 S.E. Finkelstein,2 and E. Fernandez3; 1Centro Medico Dean Funes, Co´rdoba, Argentina, 2 21st Century Oncology, Scottsdale, AZ, 321st Century Oncology, Fort Lauderdale, FL Purpose/Objective(s): Definitive techniques of chemoradiation for anal cancer, 3DCRT or IMRT result in excellent long- term outcomes as shown in RTOG protocols. Nevertheless, convincing data demonstrating its advantages remains scarce. The goal of contemporary treatment for this disease is cure without the need for a colostomy. We were interested in the outcomes of our patients who were treated in a community-based radiation treatment centers. Materials/Methods: This is a multi-center retrospective review of data in 281 patients who were treated with definitive chemoradiation therapy for locoregional anal carcinoma between 1992 and 2010. All of them were preoperatively assessed by a surgeon. Ninety-five percent underwent
2305 Phase I Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma S. Yu,1 Z. Xiao,2 Z. Zhou,3 H. Zhang,3 C. Dongfu,4 Q. Feng,5 and J. Liang6; 1Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China, 2Cancer Hospital, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China, 3Chinese Academy of Medical Science, Cancer Hospital, Peking Union Medical College, Beijing, China, 4Chinese Academy of Medical Science, Cancer Hospital, Peking Union Medical College Academy of Medical Science, Cancer Hospital, Peking Union Medical College, Beijing, China, 5Cancer Hospital/Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, CA, China, 6Cancer Institute & Hospital Chinese Academy of Medical Sciences, Beijing, China Purpose/Objective(s): To explore the maximum tolerated dose (MTD) and clinical target volume (CTV) of concurrent chemoradiation for thoracic esophageal squamous cell carcinoma with pathologically positive lymph nodes after radical esophagectomy. Materials/Methods: Eligible patients with thoracic esophageal squamous cell carcinoma after radical surgery had positive lymph nodes, and no allergic history. Patients received 5 or 6 weekly cycles of paclitaxel (20, 30, 40 or 50 mg/m2 for Dose Levels 1,2,3 and 4, respectively) and cisplatin (20mg/m2for Dose Levels 1-4) concurrent with continuous course of intensity modulated radiation therapy (54Gy in 30 fractions or 60Gy in 30fractions). The upper borderline of CTV was cricothyroid membrane and the lower borderline was celiac axis. The dose-limiting toxicities (DLT) were defined as Grade 4 leukopenia, Grade 3 thrombocytopenia or anemia, and Grade 3 non-hematologic toxicities. Results: Between July 2007 and December 2011, 33 patients were enrolled in the study. 75% of them were identified as StageT3-4. Median follow-up was 54.1 months. DLTs were observed as a grade 3 weight loss in the 3 patients of 1st level of 60Gy/2.0Gy/30f cohort one of the additional three patients experienced grade 4 leukopenia. In 54Gy/1.8Gy/30f
Volume 93 Number 3S Supplement 2015 cohort, one patient suffered from allergy to paclitaxel, the rest eleven patients completed whole treatment schedule. However, a Grade 4 leukopenia and a Grade 3 thrombocytopenia were observed in the 3 patients of 4th level of 54Gy/1.8Gy/30f cohort. The MTD was 5 or 6 weekly cycles of paclitaxel 40 mg/m2 and cisplatin 20 mg/m2concurrent with 54 Gy of radiation therapy. After that, CTV was adjusted into upper borderline of the first thoracic vertebra to 3cm below tumor bed. No DLT was observed in the 12 patients in 60 Gy/2.0 Gy/30f cohort. One year overall survival was 81.8%. The volume of clinical target and the mean dose of stomach were significantly reduced because of revision (P Z 0.006, P Z 0.015). One patient had abdominal lymph nodes below celiac axis recurrence after target modification. Conclusion: Weekly cycle of paclitaxel and cisplatin was proven to be safe and efficacious with postoperative radiation of suitable extent of CTV for node-positive thoracic esophageal carcinoma. A Phase II study evaluating Dose Level 4 is ongoing. Author Disclosure: S. Yu: None. Z. Xiao: None. Z. Zhou: None. H. Zhang: None. C. Dongfu: None. Q. Feng: None. J. Liang: None.
2306 Comparison of Perioperative Chemotherapy and Adjuvant Chemoradiation in Resected Gastric Cancer C.D. Corso,1 E.H. Wang,1 N.H. Lester-Coll,1 C.E. Rutter,1 D.N. Yeboa,1 B.R. Mancini,1 J.B. Yu,2 K.L. Johung,3 and H.S.M. Park1; 1Yale School of Medicine, New Haven, CT, 2Yale University, New Haven, CT, 3Yale University School of Medicine, New Haven, CT Purpose/Objective(s): The optimal perioperative management strategy for resectable gastric cancer is not well defined. The MAGIC and INT 0116 trials found an overall survival (OS) benefit of perioperative chemotherapy and adjuvant chemoradiation, respectively, over surgery alone. However, these two treatment regimens have not been directly compared in a randomized trial. In this study, we identify demographic and clinical factors associated with the receipt of each treatment and compare OS between the two regimens in a large national cohort. Materials/Methods: Using the National Cancer Data Base, we identified adult patients diagnosed with gastric adenocarcinoma between 2006-2011 who underwent margin-negative gastrectomy with lymph node examination and either (1) multiple courses of multi-agent neoadjuvant and adjuvant chemotherapy (CT) or (2) adjuvant concurrent chemotherapy and radiation therapy to 45 Gy targeted to the stomach or esophagus (CRT). Patients with M1 disease (clinical or pathologic stage) and T1N0 disease (clinical stage for CT and pathologic stage for CRT) were excluded. Multivariable logistic regression was performed to identify factors independently associated with receipt of each regimen. Analysis of OS was planned using the log-rank test and Cox proportional hazards regression. Propensity score matching (PSM) with 1:1 nearest-neighbor matching without replacement was performed using variables found to be significant on logistic regression. Results: We identified 746 patients who met inclusion criteria, among whom 513 (68.8%) received CRT while 233 patients (31.2%) received CT. The median age was 62, and 49.7% were clinically node-positive. Factors associated with receipt of CT on logistic regression included recent year of diagnosis, private insurance status, further travel distance to reporting facility, higher clinical T and N stage, and greater extent of gastrectomy (near-total/total vs. subtotal) (all P<0.001). In the unmatched cohort, there was no significant difference in OS between CT and CRT (3-year OS 60.1% vs. 66.5%, log-rank PZ0.62). Cox regression was not performed since the proportional hazards assumption was violated. PSM identified a matched cohort of 466 patients (233 per group). We identified no significant difference in OS between treatment groups in the matched cohort or in the clinically node-positive subset (both log-rank P>0.1). Conclusion: Perioperative chemotherapy and adjuvant chemoradiation are associated with similar OS in a national cohort of patients with marginnegative resected gastric cancer. These results suggest that both regimens
Poster Viewing Session E121 are reasonable treatment approaches and that further studies are needed to define patients who may benefit from radiation therapy. Author Disclosure: C.D. Corso: None. E.H. Wang: None. N.H. LesterColl: None. C.E. Rutter: None. D.N. Yeboa: None. B.R. Mancini: None. J.B. Yu: Research Grant; 21st Century. K.L. Johung: None. H.S. Park: None.
2307 A Phase II Study of Magnetic Resonance Imaging Guided Hematopoietical Bone Marrow Sparing Intensity Modulated Radiation Therapy With Concurrent Chemotherapy for Gastric Cancer J. Wang,1 Y. Tian,1 Y. Tang,1 X. Wang,1 N. Li,2 H. Ren,1 H. Fang,3 Y. Feng,1 J. Jin,1 S.L. Wang,1 Y. Song,1 Y. Liu,3 W. Wang,1 and Y. Li1; 1 Cancer Hospital & Institute, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 2Cancer Hospital & Institute, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 3Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China Purpose/Objective(s): Both radiation and chemotherapy are myelosuppressive and more than one-half of the body’s hematopoietically active bone marrow (BM) is located in the pelvic bones, thoracic (T) and lumbar vertebra (L) in adults. It is hypothesized that sparing the hematopoietical active bone marrow identified by magnetic resonance (MR) may reduce acute hematologic toxicity (HT) in postoperative gastric cancer patients treated with concurrent chemoradiation therapy. Materials/Methods: A prospective, open-label, single-arm phase II study (Clinicaltrials.gov registration number: NCT 01863420) was conducted in patients with histologically proven adenocarcinoma of the stomach and suitable for postoperative concurrent chemoradiation therapy. All the patients received MR scanning of vertebral body T8-L4 no later than 7 days before computer tomography (CT) simulation (CTsim). Then MR images were fused with CT-sim images. BM in T1weighted images showing a signal intensity equal to or slightly higher than that of muscle were contoured as active BM, which were contoured as an organ at risk in the treatment plan. Dose constraints for active BM were as follows: V5 (volume receiving a dose of 5 Gy or more) <90%, V10<85%, V20<75%, V30<60% and V40<35%. The treatment regimen consisted of 45 Gy of radiation at 1.8 Gy per day, with concurrent daily capecitabine (1600 mg/m2/d) postoperatively. Primary endpoints were hematologic nadirs and highest grade of each HT occurring within 60 days of initiation of chemoradiation therapy. Multivariable linear regression model is used to test to correlation between HT and dose-volume of BM. Results: A total of 25 staged II/III gastric cancer patients were prospectively enrolled. Twenty four patients (96%) had Stage T3-4 disease, and 22 patients (88%) had node-positive disease. The median age of cohort was 53 years (range, 28e73 years). Before concurrent chemoradiation therapy, adjuvant chemotherapy was administered with a mean cycle of 4.3 0.5. Only 4 patients (16%) developed Grade 3-4 HT during treatment, in which 2 (8.0%), 2 (8.0%), and 2 (8.0%) patients experienced acute Grade 3-4 leukopenia, neutropenia and thrombocytopenia, respectively. None of Grade 3-4 anemia happened. Multivariable logistic linear regression revealed BM-V5 (pZ0.03) and BM-V20 (pZ0.002) were significantly associated with decreased white blood cells (WBC) nadirs, BM-V20 (p<0.001) with decreased absolute neutrophil count nadirs, BM-V30 (pZ0.002) and volume of BM (pZ0.001) with decreased platelet count nadirs. Conclusion: Irradiation of active BM identified by MR is associated with HT. Techniques to limit low dose radiation to BM could reduce HT in gastric cancer patients. Author Disclosure: J. Wang: None. Y. Tian: None. Y. Tang: None. X. Wang: None. N. Li: None. H. Ren: None. H. Fang: None. Y. Feng: None. J. Jin: None. S. Wang: None. Y. Song: None. Y. Liu: None. W. Wang: None. Y. Li: None.