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Comparing Capecitabine Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin With Concurrent Capecitabine Radiation Therapy in Completely Resected Gastric Cancer
S316
International Journal of Radiation Oncology Biology Physics
for 5 weeks) and 10.4 Gy to residual or microscopic area as a boost. Capecitabine was administered twice daily in every radiation therapy day at a dosage of 625 (Level I, n Z 6), 700 (Level II, n Z 6), 800 (Level III, n Z 6), 900 (Level IV, n Z 0), 1000 mg/m2 (Level V, n Z 0). DLT was defined as grade 3 or 4 hematologic and nonhematologic toxicities. Results: Between June 2008 and May 2009, 18 consecutive patients (R0 11; R1 2; R2 5) were recruited. Grade 1-3 leukopenia, anorexia, and nausea were the most common toxic side effects, which accounted for 16 (88.9%), 15 (83.3%) and 15 patients (83.3%), though most were within Grade 1-2. Grade 3 anorexia and nausea and grade 4 vomit were observed in 1/6 patient in level I. In level II, 1 of first 3 patients encountered grade 3 anorexia and nausea. When upgraded to level III, 2 patients had grade 3 neutropenia and 1 had grade 3 radiation esophagitis. Therefore, the trial was ended and no more upgrade to the next levels of IV and V. Conclusions: In patients with locally advanced gastric cancer treated with concurrent capecitabine and IMRT as an adjuvant setting, the MTD of capecitabine is 800 mg/m2, twice daily and the DLT are leukopenia, anorexia, nausea/vomit and radiation esophagitis. A phase II study is warranted to test the defined dose level in the future. Author Disclosure: X. Wang: None. J. Jing: None. Y. Li: None. S. Wang: None. W. Wang: None. Y. Song: None. Y. Liu: None. H. Ren: None. H. Fang: None.
Conclusions: In our study, less neurosensory toxicity was detected in chemoradiation therapy although the benefit of combination of XELOX chemotherapy and radiation therapy cannot be found. A larger scale investigation is to be expected. Author Disclosure: L.Y. Zhang: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047. Y.Y. Wu: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047. J.J. Qian: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b055z, Social development projects in Suzhou city ss08047. L.S. Chen: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047. Y. Tian: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047.
2258 Comparing Capecitabine Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin With Concurrent Capecitabine Radiation Therapy in Completely Resected Gastric Cancer L.Y. Zhang,1 Y.Y. Wu,2 J.J. Qian,1 L.S. Chen,1 and Y. Tian1; 1Department of Radiotherapy & Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China, 2Department of General Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China Purpose/Objective(s): Postoperative chemoradiation therapy has been adopted as standard treatments in the USA and Europe for patients with resectable gastric cancer. However, the recommendation has not been totally accepted in China. Adjuvant chemotherapy with capecitabine and oxaliplatin (XELOX) was proved to be beneficial for the patients with D2 gastrectomy in CLASSIC study. The purpose of current study is to demonstrate whether the combination of XELOX chemotherapy and radiation therapy concurrently with capecitabine chemotherapy will improve the clinical outcome of the patients with curatively resected gastric cancer in China. Materials/Methods: A total of 78 patients with stage IIA-IIIC gastric cancer were collected from our hospital. After surgery, they were assigned to two groups: the chemoradiation therapy group and the single chemotherapy group. The technique of intensity-modulated radiation therapy was adopted. The chemotherapy arm received 6w8 cycles of XELOX (capecitabine 2,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130 mg/m2 on day 1, repeated every 3 weeks) chemotherapy. The chemoradiation therapy arm received 45-Gy XRT (capecitabine 1,250 mg/m2 per day for 5 weeks, excluding weekends) followed by 4w6 cycles of XELOX. The 1year survival rate was evaluated, as well as the hematologic, neurosensory, and gastrointestinal toxic effects. Acute toxic reactions were evaluated using the criteria described by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Results: Of 78 patients, 38 patients received sequence chemoradiation therapy following radical resection, and 40 patients received chemotherapy alone following radical resection. More than 80% had undergone D2 gastrectomy. Median follow-up was 17 months, the rate of follow-up is 96%. The 1-year survival rate of the sequence chemoradiation therapy group was 92% while 88% in the chemotherapy only group. The free disease survival rate was 87% and 80% respectively. The local control rate was 97% and 90% respectively. Although in the two groups no statistic significant difference was found in the hematologic and gastrointestinal toxic effects, grade 3 neurosensory toxicity was more frequent in chemotherapy group(9% Vs 28%, 0.01
2259 Sociodemographic Factors Associated With Management of Gastric Cancer: QRRO/CURE Results J. Owen,1 A. Ho,1 L.A. Kachnic,2 B.D. Minsky,3 K.A. Goodman,4 N. Khalid,1 J. Wilson,5 and C.R. Thomas6; 1American College of Radiology Clinical Research Center, Philadelphia, PA, 2Boston University Medical Center, Boston, MA, 3University of Chicago Medical Center, Chicago, IL, 4Memorial Sloan-Kettering Cancer Center, New York, NY, 5 Medical College of Wisconsin, Milwaukee, WI, 6Oregon Health & Science University, Portland, OR Purpose/Objective(s): Quality Research in Radiation Oncology (QRRO) surveyed US radiation therapy (RT) facilities to evaluate the quality of gastric cancer (GC) treatment in 2005-07. The specific aim of this report is to describe sociodemographic (SOC) factors that influence work-up and treatment of GC patients (pts). Materials/Methods: The QRRO national survey used a two-stage stratified random sample of GC treated with RT: 250 cases from 45 institutions (6 facilities had no eligible pts). Eligibility: RT receipt in 2005-2007 for stomach or gastroesophageal (GE) junction tumors with stages Ib-IV (nonmetastatic); histology of adenocarcinoma, squamous, adenosquamous; Karnofsky score 60. Exclusions: distant metastases or prior malignancy within 5 yrs. Five SOC variables based on 2000 US Census data were analyzed for association with clinical factors: pts living in urban vs. rural settings (U/R), median household income (HI), % below poverty level (POV), % unemployed (U) and % with college education (CE). U/R had three categories: 100% urban, 100% rural or urban/rural mix. HI, POV, U, and CE were defined as above or below the median values of this sample. Pts were linked to census data values by home ZIP code. Six pts did not link and were excluded from the analysis. National estimates used weighted averages. Results: Of the 244 cases 96.2% had adenocarcinoma; 13.7% were Stage 1b, 27.4% II, 30.1% IIIA, 9.2% IIIB, 13.5% IV, 6.0% unknown. Primary location was 35.0% antrum, 14.0% corpus, 11.7% cardia, 32.9% GE junction, 6.5% unknown. Median age was 63 yrs; 64.7% were male; 17.3% African American; 14.3% Hispanic. Median RT dose was 45 Gy; median RT duration 36 days. A total of 14.7% had AP/PA technique, 14.2% 3field, 45.9% 4-field, 19.8% >4 fields. Gastrointestinal bleeding and transfusion use (T) varied by U/R (20.8% no T, 16.4% T in urban; 7.2% No T, 13.8% T U/R mixed; 9.9% No T, 2.7% T rural; p Z 0.03). Endoscopy was performed in >95% of cases in each area. Use of endoscopic ultrasound varied by U/R (16.7% in urban, 36.8% U/R mixed, 22.6% rural; p Z 0.03). Chest CT was done more in lower U (85.2% vs. 63.8%; p Z 0.02), PET more in lower POV (58.0% vs. 38.0%; p Z 0.02) and lower U areas (58.3% vs. 37.8%; p Z 0.02), MRI more in lower POV and U (both 11.4% vs. 1.7%; p Z 0.03). Surgical resection was done less in lower POV (71.7% vs. 87.8%; p Z 0.02). External beam technique varied by U/R with AP/PA more common in rural and 4-field more common in urban areas (p Z 0.02). IMRT use varied by U/R (27.6% urban, 12.5% U/R mixed, 0% rural; p < 0.01).
International Journal of Radiation Oncology Biology Physics
for 5 weeks) and 10.4 Gy to residual or microscopic area as a boost. Capecitabine was administered twice daily in every radiation therapy day at a dosage of 625 (Level I, n Z 6), 700 (Level II, n Z 6), 800 (Level III, n Z 6), 900 (Level IV, n Z 0), 1000 mg/m2 (Level V, n Z 0). DLT was defined as grade 3 or 4 hematologic and nonhematologic toxicities. Results: Between June 2008 and May 2009, 18 consecutive patients (R0 11; R1 2; R2 5) were recruited. Grade 1-3 leukopenia, anorexia, and nausea were the most common toxic side effects, which accounted for 16 (88.9%), 15 (83.3%) and 15 patients (83.3%), though most were within Grade 1-2. Grade 3 anorexia and nausea and grade 4 vomit were observed in 1/6 patient in level I. In level II, 1 of first 3 patients encountered grade 3 anorexia and nausea. When upgraded to level III, 2 patients had grade 3 neutropenia and 1 had grade 3 radiation esophagitis. Therefore, the trial was ended and no more upgrade to the next levels of IV and V. Conclusions: In patients with locally advanced gastric cancer treated with concurrent capecitabine and IMRT as an adjuvant setting, the MTD of capecitabine is 800 mg/m2, twice daily and the DLT are leukopenia, anorexia, nausea/vomit and radiation esophagitis. A phase II study is warranted to test the defined dose level in the future. Author Disclosure: X. Wang: None. J. Jing: None. Y. Li: None. S. Wang: None. W. Wang: None. Y. Song: None. Y. Liu: None. H. Ren: None. H. Fang: None.
Conclusions: In our study, less neurosensory toxicity was detected in chemoradiation therapy although the benefit of combination of XELOX chemotherapy and radiation therapy cannot be found. A larger scale investigation is to be expected. Author Disclosure: L.Y. Zhang: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047. Y.Y. Wu: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047. J.J. Qian: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b055z, Social development projects in Suzhou city ss08047. L.S. Chen: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047. Y. Tian: E. Research Grant; Project of Postgraduate’s Innovation of Jiangsu Province cx10b-055z, Social development projects in Suzhou city ss08047.
2258 Comparing Capecitabine Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin With Concurrent Capecitabine Radiation Therapy in Completely Resected Gastric Cancer L.Y. Zhang,1 Y.Y. Wu,2 J.J. Qian,1 L.S. Chen,1 and Y. Tian1; 1Department of Radiotherapy & Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China, 2Department of General Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China Purpose/Objective(s): Postoperative chemoradiation therapy has been adopted as standard treatments in the USA and Europe for patients with resectable gastric cancer. However, the recommendation has not been totally accepted in China. Adjuvant chemotherapy with capecitabine and oxaliplatin (XELOX) was proved to be beneficial for the patients with D2 gastrectomy in CLASSIC study. The purpose of current study is to demonstrate whether the combination of XELOX chemotherapy and radiation therapy concurrently with capecitabine chemotherapy will improve the clinical outcome of the patients with curatively resected gastric cancer in China. Materials/Methods: A total of 78 patients with stage IIA-IIIC gastric cancer were collected from our hospital. After surgery, they were assigned to two groups: the chemoradiation therapy group and the single chemotherapy group. The technique of intensity-modulated radiation therapy was adopted. The chemotherapy arm received 6w8 cycles of XELOX (capecitabine 2,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130 mg/m2 on day 1, repeated every 3 weeks) chemotherapy. The chemoradiation therapy arm received 45-Gy XRT (capecitabine 1,250 mg/m2 per day for 5 weeks, excluding weekends) followed by 4w6 cycles of XELOX. The 1year survival rate was evaluated, as well as the hematologic, neurosensory, and gastrointestinal toxic effects. Acute toxic reactions were evaluated using the criteria described by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Results: Of 78 patients, 38 patients received sequence chemoradiation therapy following radical resection, and 40 patients received chemotherapy alone following radical resection. More than 80% had undergone D2 gastrectomy. Median follow-up was 17 months, the rate of follow-up is 96%. The 1-year survival rate of the sequence chemoradiation therapy group was 92% while 88% in the chemotherapy only group. The free disease survival rate was 87% and 80% respectively. The local control rate was 97% and 90% respectively. Although in the two groups no statistic significant difference was found in the hematologic and gastrointestinal toxic effects, grade 3 neurosensory toxicity was more frequent in chemotherapy group(9% Vs 28%, 0.01
2259 Sociodemographic Factors Associated With Management of Gastric Cancer: QRRO/CURE Results J. Owen,1 A. Ho,1 L.A. Kachnic,2 B.D. Minsky,3 K.A. Goodman,4 N. Khalid,1 J. Wilson,5 and C.R. Thomas6; 1American College of Radiology Clinical Research Center, Philadelphia, PA, 2Boston University Medical Center, Boston, MA, 3University of Chicago Medical Center, Chicago, IL, 4Memorial Sloan-Kettering Cancer Center, New York, NY, 5 Medical College of Wisconsin, Milwaukee, WI, 6Oregon Health & Science University, Portland, OR Purpose/Objective(s): Quality Research in Radiation Oncology (QRRO) surveyed US radiation therapy (RT) facilities to evaluate the quality of gastric cancer (GC) treatment in 2005-07. The specific aim of this report is to describe sociodemographic (SOC) factors that influence work-up and treatment of GC patients (pts). Materials/Methods: The QRRO national survey used a two-stage stratified random sample of GC treated with RT: 250 cases from 45 institutions (6 facilities had no eligible pts). Eligibility: RT receipt in 2005-2007 for stomach or gastroesophageal (GE) junction tumors with stages Ib-IV (nonmetastatic); histology of adenocarcinoma, squamous, adenosquamous; Karnofsky score 60. Exclusions: distant metastases or prior malignancy within 5 yrs. Five SOC variables based on 2000 US Census data were analyzed for association with clinical factors: pts living in urban vs. rural settings (U/R), median household income (HI), % below poverty level (POV), % unemployed (U) and % with college education (CE). U/R had three categories: 100% urban, 100% rural or urban/rural mix. HI, POV, U, and CE were defined as above or below the median values of this sample. Pts were linked to census data values by home ZIP code. Six pts did not link and were excluded from the analysis. National estimates used weighted averages. Results: Of the 244 cases 96.2% had adenocarcinoma; 13.7% were Stage 1b, 27.4% II, 30.1% IIIA, 9.2% IIIB, 13.5% IV, 6.0% unknown. Primary location was 35.0% antrum, 14.0% corpus, 11.7% cardia, 32.9% GE junction, 6.5% unknown. Median age was 63 yrs; 64.7% were male; 17.3% African American; 14.3% Hispanic. Median RT dose was 45 Gy; median RT duration 36 days. A total of 14.7% had AP/PA technique, 14.2% 3field, 45.9% 4-field, 19.8% >4 fields. Gastrointestinal bleeding and transfusion use (T) varied by U/R (20.8% no T, 16.4% T in urban; 7.2% No T, 13.8% T U/R mixed; 9.9% No T, 2.7% T rural; p Z 0.03). Endoscopy was performed in >95% of cases in each area. Use of endoscopic ultrasound varied by U/R (16.7% in urban, 36.8% U/R mixed, 22.6% rural; p Z 0.03). Chest CT was done more in lower U (85.2% vs. 63.8%; p Z 0.02), PET more in lower POV (58.0% vs. 38.0%; p Z 0.02) and lower U areas (58.3% vs. 37.8%; p Z 0.02), MRI more in lower POV and U (both 11.4% vs. 1.7%; p Z 0.03). Surgical resection was done less in lower POV (71.7% vs. 87.8%; p Z 0.02). External beam technique varied by U/R with AP/PA more common in rural and 4-field more common in urban areas (p Z 0.02). IMRT use varied by U/R (27.6% urban, 12.5% U/R mixed, 0% rural; p < 0.01).