Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase Ⅰ studies,two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one tria1,118 patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT trial), with radio-therapy of DT50 Gy/25 F/5 wks to the pelvis, and capecitabine at a dose of 1600 mg/m2/d(d1-d14,3 weeks per cycle). In the other trial, 90 patients received concurrent oxaliplatin, capecitabine and radiothera-py(Cap-Oxa-CRT trial), with the same radiotherapy schedule, while oxaliplatin at a dose of 70 mg/m2(d1, d8) and capecitabine of 1300 mg/m2/d(d1-d14,3 weeks per cycle). Results There was no significant difference in the delay of radiotherapy (10.2% vs 6.7%, X2=0.80, P=0.460) or chemotherapy (9.3% vs 19.1%, X2=4.80,P=0.090) between Cap-CRT and Cap-Oxa-CRT trials. Grade 1-4 leukopenia,diar-rhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2%, 65.9% and 42.3%, respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1-4 non-hemotological toxicities, mainly in Gl,including nausea (68.9% vs 22.0%, X2=46.90, P= 0.000), diarrbea(76.7% vs 57.6%, X2=13.50, P=0.009), fatigne(47.8% vs 13.7%, X2=18.90,P= 0.000), hand-foot syndrome (14.4% vs 4.2%, X2=7.10, P=0.029), and inappetence (50.0% vs. 27.9%, X2 = 25.70, P=0.000), but not in hematological toxities of leukopenia, anemia or thrombocytope-nia. Of all the patients,grade 3 and grade 4 toxicities were diarrhea(24.0% and 1.0%),leukopenia(4.3% and 0.0%),radiation-induced dermatitis(3.8% and 0.0%),cramping abdominal pain(1.0% and 0.0%) and fatigue(0.5% and 0.0%). Only grade 3 and 4 diarrhea was significantly more in Cap-Oxa-CRT trial than in Cap-CBT trial(33.0% vs 18.6%, X2=5.90,P=0.023). Conclusions For patients with stage Ⅱ and Ⅲ rectal cancer,both the postoperative concurrent radiochemotherapy regimens are tolerable,though Cap-Oxa-CRT trial has more grade 3 and 4 diarrhea.     

三维放疗联合顺铂同期化疗局部晚期宫颈癌疗效分析

Objective To analyze the therapeutic efficacy and treatment related toxicities for patients with locally advanced cervical cancer treated with three-dimensional conformal radiotherapy (3DCRT) combined with concurrent chemotherapy. Methods From January 2007 to February 2008, 181 patients with stage ⅡA-ⅣA cervical cancer were retrospectively analyzed. All patients were treated with CT-based three-dimensional external beam and 192Ir intracavity radiotherapy combined with concurrent weekly cisplatin-based chemotherapy. The median age was 50 years (range, 32 to 82 years). The overall survival ( OS), disease-free survival (DFS) and local control (LC) rates were calcalated by Kaplan-Meier method and the difference was compared using Log-rank test. The treatment related toxicities were evaluated according to Radiotherapy Oncology Group (RTOG) criteria. Results With a median follow-up time of 34 months and following rate of 92. 2%, the 3-year OS, DFS and LC rates were 73.4%, 70. 4% and 91.3%,respectively. The 3-year OS rate was 66. 9% for patients with tumor diameter ≥4 cm and 86. 4% for those with tumor diameter ＜4 cm( χ2 =6. 29 ,P =0. 012). The incidences of grade 1 and grade 2 acute toxicities of the lower gastrointestinal tract and the genitourinary system were 40. 0% ,45.0% and 19. 9% ,4. 4%,retrospectively. There were no grade 3 or more acute toxicities. The incidence of grades 3 or 4 late toxicities of the lower gastrointestinal tract was 4. 9%. Conclusions CT-based three-dimensional external beam and 192Ir intracavity radiotherapy combined with concurrent chemotherapy can achieve good therapeutic effects for locally advanced cervical cancer. The acute and late toxicities are significantly reduced compared with historic controls as a result of incorporation of 3DCRT technique.     

Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients:A phaseⅡclinical trial

Objective:To investigate the safety and efficacy of nimotuzumab combined with radiotherapy for elderly patients with non-resectable esophageal carcinoma(EC).Methods:Eligible patients were aged 70 years or older and had treatment-naive,histologically proven inoperable locally advanced EC.Enrolled patients received radiotherapy with a total dose of 50-60 Gy in 25-30 fractions,concurrent with weekly infusion of nimotuzumab.The primary end point was the rate of more than grade 3 toxicities.Results:From June 2011 to July 2016,46 patients with stageⅡ-IV EC with a median age of 76.5 years were enrolled.There were 10,28 and 8 patients with stageⅡ,III and IV disease,respectively.The common acute toxicities included esophagitis(grade 1-2,75.4%;grade 3,8.7%),pneumonitis(grade 1,4.3%;grade 2,6.5%;grade3,2.2%),leukopenia(grade 1-2,60.9%;grade 3-4,4.4%),gastrointestinal reaction(grade 1-2,17.3%;grade 3,2.2%),thrombocytopenia(grade 1-2,21.7%;grade 3,2.2%),and radiothermitis(grade 1-2,39.2%).The incidence of grade 3-4 adverse effects was 17.4%.No grade 5 toxicities were observed.Clinical complete response,partial response,stable disease,and progressive disease were observed in 1(2.2%),31(67.4%),12(26.1%),and 2(4.3%)patients,respectively.The median overall survival(OS)and progression-free survival(PFS)were 17 and 10 months,respectively.The 2-,3-,and 5-year OS and PFS rates were 30.4%,21.7%,19.6%,and 26.1%,19.6%,19.6%,respectively.Conclusions:Nimotuzumab combined with radiotherapy is a safe and effective therapy for elderly patients who are not surgical candidates.Further studies are warranted to confirm its therapeutic effects in elderly EC patients.     

奥沙利铂联合卡培他滨治疗晚期及复发转移性胃癌的临床观察

Objective To investigate the therapeutic effect and side effect of combined capecitabine with oxaliplatin on advanced and recurrent gastric cancer.Methods 56 patients with advanced and recurrent gastric cancer were treated with combined oxaliplatin and capecitabine chemotherapy,and the therapeutic effect and side effect were analyzed retrospectively.Results Among all 56 patients treated with combined oxaliplatin and capecitabine chemotherapy,4 patients (7.1%) were complete remission,26 patients (46.4 %)were partial remission,20 patients (35.7 %) were stabilization,6 patients (10.7 %) were progression,and the response rate was 53.6 %.The median remission time was 7.8 months,and the median survival time was 11.3 months.The main side effects were nausea and vomiting,diarrhea,hand-foot syndrome,peripheral nerve toxicity,transaminase increasing and leuco cytopenia,however,the side effects were mainly grade Ⅰ and Ⅱwhich could be tolerated by patients.Conclusion The combined oxaliplatin and capecitabine chemotherapy is an effective method and has better tolerance in treatment of advanced gastric cancer and is well worth clinical application.     

术前同期放化疗治疗肺上沟瘤的疗效分析

Objective: To compare the clinical effect and toxicities of preoperative concurrent chemoradiotherapy (CT/RT)with radiotherapy (RT) alone in patients with superior sulcus lung tumor. Methods: Fifty-six patients with superior sulcus lung tumor were divided randomly into two groups: twenty-six patients received concurrent chemoradiotherapy, the other thirty patients received only radiotherapy. For both groups, the same radiation technic was given with the convention fraction. The total dose was 45 Gy/25 Fr/5 Wk. For the CT/RT group, the patients were also given with concurrent chemotherapy (navelbine 15-18 mg/m2 on the 1st and 8th day, cisplatin 60 mg/m2 on the 1 st day). Results: The rate of complete resection in the CT/RT group was significantly higher than that in the RT group (92.3% vs 80%, P ＜ 0.05). The complete pathological response rate and 2-year survival rate in the CT/RT group were significantly higher than those in the RT group (P ＜ 0.01, P ＜ 0.01). The incidences of grades Ⅲ-Ⅳ radiation esophagitis and leukopenia in the CT/RT group were significantly higher than those in the RT group (23.1% and 23.1% vs 6.7% and 0, P ＜ 0.01, P ＜ 0.01). Conclusion: Preoperative concurrent chemoradiotherapy has the potential of improving the survival rate of superior sulcus lung tumors. Though this treatment regimen also increases the acute toxic effect, all patients can tolerate it. It is expected to be a new "standard treatment" for this malignant tumor.     

奥沙利铂联合卡培他滨治疗晚期及复发转移性胃癌的临床观察

Objective To investigate the therapeutic effect and side effect of combined capecitabine with oxaliplatin on advanced and recurrent gastric cancer.Methods 56 patients with advanced and recurrent gastric cancer were treated with combined oxaliplatin and capecitabine chemotherapy,and the therapeutic effect and side effect were analyzed retrospectively.Results Among all 56 patients treated with combined oxaliplatin and capecitabine chemotherapy,4 patients (7.1%) were complete remission,26 patients (46.4 %)were partial remission,20 patients (35.7 %) were stabilization,6 patients (10.7 %) were progression,and the response rate was 53.6 %.The median remission time was 7.8 months,and the median survival time was 11.3 months.The main side effects were nausea and vomiting,diarrhea,hand-foot syndrome,peripheral nerve toxicity,transaminase increasing and leuco cytopenia,however,the side effects were mainly grade Ⅰ and Ⅱwhich could be tolerated by patients.Conclusion The combined oxaliplatin and capecitabine chemotherapy is an effective method and has better tolerance in treatment of advanced gastric cancer and is well worth clinical application.     

Phase II study ofoxaliplatin combined withS-1 andleucovorin (SOL) forChinese patients withmetastatic colorectal cancer

Background:Fluoropyrimidine and oxaliplatin are widely used for patients with colorectal cancer. This phase II study was conducted to evaluate the effcacy and safety of the combination of S?1, oxaliplatin, and leucovorin (SOL) in the treatment of Chinese patients with metastatic colorectal cancer (mCRC). Methods:Eligible patients with untreated mCRC from four hospitals in China received intravenous oxaliplatin (85mg/m2) on day 1, oral S?1 twice daily (80–120mg per day) on day 1–7, and leucovorin twice daily (50mg per day) simultaneously with S?1, every 2weeks. Results and discussion:Forty patients were enrolled in our study. In total, 296 cycles of SOL were administered. The overall response rate was 50.0%. At a median follow?up of 27months, progression?free survival and overall survival were 7.0months (95% conifdence interval [CI] 6.0–10.6months) and 22.2months (95% CI 15.1–29.3months), respec?tively. The most common grade 3/4 non?hematological adverse events were diarrhea (n=8, 20.0%), nausea (n=3, 7.5%), and vomiting (n=3, 7.5%). The most common grade 3/4 hematological toxicities were thrombocytopenia (n=3, 7.5%), neutropenia (n=1, 2.5%), and abnormal alanine transaminase/aspartate transaminase levels (n=1, 2.5%). There was one treatment?related death. Conclusions:The data indicate that the SOL regimen is effective and moderately tolerated in Chinese patients with mCRC. Trial registration: Clinical trial information: ChiCTR?TNRC?100000838.     

三维放疗联合顺铂同期化疗局部晚期宫颈癌疗效分析

目的 分析CT图像为基础三维适形放疗联合顺铂同期化疗对晚期宫颈癌患者疗效及副反应情况.方法 回顾分析2007-2008年本科收治的181例Ⅱa～Ⅳa期宫颈癌患者资料,其中年龄32～82岁(中位数50岁).放疗采用以CT图像为基础的三维适形放疗和三维192Ir后装照射技术,同期联合顺铂单药每周化疗方案.结果 随访中位数34个月,随访率为92.2%.全组患者3年总生存率为73.4%、无瘤生存率为70.4%、盆腔控制率为91.3%.肿瘤直径≥4 cm和＜4 cm者总生存率分别为66.9%和86.4%(χ2=6.29,P=0.012).RTOG分级急性胃肠道副反应1、2级发生率分别为40.0%、45.0%,泌尿系副反应l、2级发生率分别为19.9%、4.4%.RTOG分级晚期下消化道副反应3+4级发生率为4.9%.结论 以CT图像为基础三维适形放疗和三维192Ir后装照射技术联合顺铂同期化疗对局部晚期宫颈癌患者疗效较好,并对降低晚期严重副反应的发生有益.

Abstract：

Objective To analyze the therapeutic efficacy and treatment related toxicities for patients with locally advanced cervical cancer treated with three-dimensional conformal radiotherapy (3DCRT) combined with concurrent chemotherapy. Methods From January 2007 to February 2008, 181 patients with stage ⅡA-ⅣA cervical cancer were retrospectively analyzed. All patients were treated with CT-based three-dimensional external beam and 192Ir intracavity radiotherapy combined with concurrent weekly cisplatin-based chemotherapy. The median age was 50 years (range, 32 to 82 years). The overall survival ( OS), disease-free survival (DFS) and local control (LC) rates were calcalated by Kaplan-Meier method and the difference was compared using Log-rank test. The treatment related toxicities were evaluated according to Radiotherapy Oncology Group (RTOG) criteria. Results With a median follow-up time of 34 months and following rate of 92. 2%, the 3-year OS, DFS and LC rates were 73.4%, 70. 4% and 91.3%,respectively. The 3-year OS rate was 66. 9% for patients with tumor diameter ≥4 cm and 86. 4% for those with tumor diameter ＜4 cm( χ2 =6. 29 ,P =0. 012). The incidences of grade 1 and grade 2 acute toxicities of the lower gastrointestinal tract and the genitourinary system were 40. 0% ,45.0% and 19. 9% ,4. 4%,retrospectively. There were no grade 3 or more acute toxicities. The incidence of grades 3 or 4 late toxicities of the lower gastrointestinal tract was 4. 9%. Conclusions CT-based three-dimensional external beam and 192Ir intracavity radiotherapy combined with concurrent chemotherapy can achieve good therapeutic effects for locally advanced cervical cancer. The acute and late toxicities are significantly reduced compared with historic controls as a result of incorporation of 3DCRT technique.     

不能手术的Ⅲ期非小细胞肺癌患者每周紫杉醇和卡铂并同步放疗的诱导化疗:一个Ⅱ期研究结果(英文)

Objective: several trials have suggested the superiority of concurrent chemoradiotherapy. It has been hypothesized that the addition of systemic dose sequential chemotherapy to concurrent chemoradiotherapy, as induction or as consolidation, might further improve survival rates. So we sought to evaluate the safety and efficacy of induction paclitaxel and carboplatin followed by weekly paclitaxel and carboplatin with concurrent radiotherapy in inoperable stage Ⅲ non-small cell lung cancer (NSCLC). Methods: Fifty-six patients with stage Ⅲ inoperable NSCLC received induction chemotherapy with 2 cycles of paclitaxel 200 mg/m2 and carboplatin AUC-6 every 3 weeks then patients were assigned to concurrent chemoradiotherapy with paclitaxel 45 mg/m2 and carboplatin AUC-2 weekly along with concurrent radiotherapy at dose of 60 Gy (1.8 Gy/d x 5 d/week). Results: Median age of the 56 eligible patients was 61 years, most of them were males (87.5%). Squamous cell carcinoma was the most common pathological type (55.4%) and 85.7% had a performance status of 1. The majority of patients were presented with stage ⅢB (62.5%). Neutropenia was the most common toxicity during induction therapy (12.5% expressed grade 3) whereas esophagitis was the most common non hematologic adverse reaction during concurrent chemoradiotherapy (14.3% of grade 3). The overall response rate was 71.6% with complete response in 19.6%. After median follow up of 20 months, the median survival time was 13 months (95% CI: 10.917-15.083) and 1 year overall survival rate was 53.6%. Conclusion: This regimen has demonstrated an acceptable toxicity profile and encouraging response to treatment. Evaluation of this regimen in larger number and a phase Ⅲ trial are recommended.     

Capecitabine maintenance therapy for XT chemotherapy-sensitive patients with metastatic triple-negative breast cancer

Objective： To investigate the efficacy and safety of capecitabine maintenance therapy（MT） after initial capecitabine plus docetaxel（XT） chemotherapy in patients with metastatic triple-negative breast cancer（m TNBC）.
Methods： Fifty-five m TNBC patients treated with XT chemotherapy between May 2007 and June 2013 were retrospectively analyzed. When initial disease control was achieved by the combination chemotherapy, capecitabine was continued for 32 patients（MT）, while 23 patients remained without any treatment（nonMT）. We compared progression-free survival（PFS） and safety of both groups.
Results： The median PFS of 55 patients was 8.1 months, overall median PFS time of 32 patients in the capecitabine MT group and 23 in the non-MT group was 10.1 vs. 6.7 months（P=0.032）, respectively. When compared PFS time of maintenance treatment, single-agent capecitabine prolonged PFS by 7.1 months, for non-MT patients, the PFS without any treatment was 3.1 months, and this between-group difference was statistically significant（P=0.003）. Adverse events, including of hematologic toxicity, gastrointestinal toxicities, hand-foot syndrome and abnormal liver function were not significantly different between two groups.
Conclusions： After initial disease control was achieved with the XT combination chemotherapy, capecitabine MT can significantly prolong PFS time with a favorable safety profile in m TNBC patients.     

伊立替康或奥沙利铂联合卡培他滨治疗晚期胃癌的疗效比较

目的 观察并比较伊立替康(CPT-11)联合卡培他滨(CAP)与奥沙利铂(L-OHP)联合CAP治疗晚期胃癌的近期疗效和毒副反应.方法 将63例晚期胃癌患者随机分为两组,CPT-11+CAP组32例,应用CPT-11联合CAP方案治疗;L-OHP+CAP组31例,应用L-OHP联合CAP方案治疗.2个周期后评价疗效及毒副反应,有效病例4周后进行疗效确认.结果 CPT-11+CAP组PR 13例,有效率为40.6%,中位无进展生存期为6.3个月.L-OHP+CAP组PR 12例,有效率为38.7%,中位无进展生存期为6.1个月.两组有效率及中位无进展生存期比较,差异均无统计学意义(P＞0.05).两组的主要毒副反应为胃肠道反应、周围神经毒性和骨髓抑制.CPT-11+CAP组Ⅲ、Ⅳ度腹泻的发生率(28.1%)高于L-OHP+CAP组(3.2%,P=0.018),Ⅲ、Ⅳ度周围神经毒性的发生率(3.1%)低于L-OHP+CAP组(25.8%,P=0.027).两组均无化疗相关性死亡.结论 CPT-11联合CAP方案与L-OHP联合CAP方案对晚期胃癌均有较好的疗效,毒副反应均可耐受.

Abstract：

Objective To observe and compare the response rate and toxicity of irinotecan or oxaliplatin combined with capecitabine in the treatment of advanced gastric cancer.Methods Sixty-three patients with advanced gastric cancer were randomly divided into two groups.The CPT-11 + CAP group consisted of 32 patients who received irinotecan plus capocitabine: CPT-11 100 mg/m2 was injected in 90 minutes on d 1,8 ;capecitabine 2000 mg/m2, bid, with the first dose in the evening of day 1 and last dose the morning of day 15, repoated for every 21 days.The L-OHP + CAP group consisted of 31 patients who received oxaliplatin plus capecitabine: oxaliplatin 100 mg/m2 on day 1, capocitabine 2000 mg/m2, bid,with the first dose in the evening of day 1 and last dose the morning of day 15, repeated for every 21 days.Two or more cycle chemotherapy was completed in each group.Results In the CPT-11 + CAP group, no patient achieved complete response and 13 patients achieved partial response.The overall response rate was 40.6% (13/32), and the median progression-free survival time was 6.3 months.In the L-OHP + CAP group, no patient achieved complete response and 12 patients achieved partial response.The overall response rate was 38.7% (12./31), and the median progression-free survival time was 6.1 months.There was no significant difference between them (P ＞ 0.05 ).The most common toxicities were gastrointestinal reaction,peripheral neuropathy and myelosuppression in the two groups.Patients in CPT-11 + CAP group experienced more Ⅲ/Ⅳ diarrhea (28.1%/3.2%, P =0.018).On the contrary, the rate of Ⅲ/Ⅳ neurotoxicity in the group B was higher (25.8%/3.1%, P = 0.027).No chemotherapy-related death occurred.Conclusion The therapeutic effects of irinotecan or oxaliplatin combined with capecitabine in the treatment of advanced gastric cancer are good and comparable, and their toxicities are tolerable.