First Oncology Clinic, Errikos Dunant Hospital, Athens, Greece.
Oncology. 2010;78(5-6):376-81. doi: 10.1159/000320520. Epub 2010 Aug 27.
The objective of this phase III trial was to compare chemotherapy combined with bevacizumab versus chemotherapy alone in the treatment of patients with advanced colorectal cancer.
From September 2004 till September 2008, 222 treatment-naive patients were enrolled and divided into 2 arms: 114 arm A patients were treated with leucovorin, 5-fluorouracil plus irinotecan in combination with bevacizumab, and 108 arm B patients were treated as above without bevacizumab. All patients were stage IV with histologically confirmed adenocarcinoma.
The median overall survival of arm A patients was 22.0 months (95% CI: 18.1-25.9) and 25.0 months (CI: 18.1-31.9) for arm B patients. There was no statistically significant difference between the 2 arms (p = 0.1391). No statistically significant difference between the 2 arms regarding the response rate was observed: partial response, 42 patients (36.8%) and 38 patients (35.2%) for arms A and B, respectively. Hematologic toxicity did not differ in the comparison of the 2 arms. Nonhematologic toxicity in arm A involved hypertension in 23 (20.2%) of the patients and proteinuria in 7 (6.1%); 3 patients experienced hemorrhage and 1 patient intestinal perforation. None of these side effects was observed in arm B patients.
No statistically significant difference in median overall survival in patients with advanced colorectal cancer treated with bevacizumab plus a combination therapy (arm A) and those treated with the combination only, without bevacizumab (arm B), was observed.
本三期临床试验的目的在于比较化疗联合贝伐单抗与单纯化疗治疗晚期结直肠癌患者的疗效。
2004 年 9 月至 2008 年 9 月，共纳入 222 例初治患者，分为两组：A 组 114 例患者接受亚叶酸钙、5-氟尿嘧啶联合伊立替康联合贝伐单抗治疗，B 组 108 例患者接受单纯化疗。所有患者均为 IV 期，组织学证实为腺癌。
A 组患者的中位总生存期为 22.0 个月（95%CI：18.1-25.9），B 组为 25.0 个月（CI：18.1-31.9）。两组间无统计学差异（p = 0.1391）。两组间的缓解率无统计学差异：A 组部分缓解 42 例（36.8%），B 组 38 例（35.2%）。两组间血液学毒性无差异。A 组非血液学毒性包括高血压 23 例（20.2%）和蛋白尿 7 例（6.1%）；3 例患者出现出血，1 例患者出现肠穿孔。B 组患者均未出现上述副作用。
在接受化疗联合贝伐单抗治疗（A 组）和单纯化疗（B 组）的晚期结直肠癌患者中，中位总生存期无统计学差异。
