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.     

Ⅱ和Ⅲ期直肠癌术后卡培他滨±奥沙利铂同步放化疗急性副反应比较

目的 比较两个前瞻性非随机对照直肠癌术后同步放化疗临床Ⅱ期研究的急性毒副反应及耐受性.方法 2005年3月至2007年11月分别进行卡培他滨术后同步放化疗(单药组,n=118)和奥沙利铂+卡培他滨术后同步放化疗(双药组,n=90)的Ⅱ期临床研究.两组均予真骨盆放疗DT50 Gy分25次5周完成,化疗药物予以连用2周停1周,放疗中共用2周期的方法 .单药组卡培他滨每天2次1600 mg/m2双药组奥沙利铂每周1次70 mg/m2,卡培他滨每天2次1300 mg/m2.结果 双药组患者中断放疗(10.2%:6.7%,X2=0.80,P=0.460)或化疗的比率(9.3%:19.1%,X2=4.80,P=0.090)与单药组相似.双药组1～4级急性非血液学毒副反应发生率显著高于单药组,主要为恶心(X2=46.90,P=0.000),腹泻(X2=13.50,P=0.009),乏力(X2=18.90,P=0.000),手足综合症(X2=7.10,P=0.029)和食欲下降(X2=19.90,P=0.000).全组发生3、4级以上严重副反应包括腹泻(24.0%、1.0%)、白细胞下降(4.3%、0.0%)、放射性皮炎(3.8%、0.0%)、腹痛(1.0%、0.0%)和乏力(0.5%、0.0%),但只有3、4级腹泻发生率双药组显著高于单药组(33.0%:18.6%,X2=5.90,P=0.023).结论 接受奥沙利铂+卡培他滨双药同步放化疗患者3、4级腹泻发生率显著高于卡培他滨单药同步放化疗,但其他严重副反应发生率低且两组相似.     

Ⅱ+Ⅲ期直肠癌根治术后卡培他滨单药±奥沙利铂同期放化疗疗效对比

目的 比较Ⅱ、Ⅲ期直肠癌根治术后卡培他滨 ±奥沙利铂同期放化疗疗效。方法 回顾分析2002—2010年分别接受卡培他滨术后同期放化疗(单药组,427例)和奥沙利铂+卡培他滨术后同期放化疗(双药组,248例)的临床资料。治疗模式均为全直肠系膜切除术+同期放化疗 ±辅助化疗。放疗方法为真骨盆 45.0~50.4 Gy分25次。结果 采用倾向评分配比法按1∶1平衡基线特征后产生单双药组各 248例,其中单药、双药组 5年样本数分别为81、104例。匹配后单、双药组的 5年OS (78.1%∶74.9%)、DFS (74.4%∶67.9%)、LRC (94.5%∶92.8%)和DMFS (77.1%∶70.9%)均相近(P=0.547、0.292、0.484、0.364),但双药组3、4级不良反应发生率显著高于单药组(38.3%∶24.6%,P=0.001)。结论 Ⅱ、Ⅲ期直肠癌根治术后卡培他滨+奥沙利铂同期放化疗疗效未优于卡培他滨单药同期放化疗,而不良反应增加。单药卡培他滨同期放化疗仍为标准方案。