Department of Colorectal and Anal Surgery, First Affiliated Hospital, Guangxi Medical University, Nanning, Guangxi, People's Republic of China.
Cancer Chemother Pharmacol. 2010 Apr;65(5):849-61. doi: 10.1007/s00280-009-1090-x. Epub 2009 Aug 13.
To assess the efficacy and safety of cetuximab-based therapy versus non-cetuximab therapy for advanced cancer.
A total of 7,954 patients from 17 randomized controlled trials are identified, with 3,965 patients in the cetuximab group and 3,989 patients in the non-cetuximab group. The outcome was progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and grade 3/4 advent events.
There was a significant improvement of PFS (HR 0.83, 95%CI 0.78-0.88), OS (HR 0.89, 0.84-0.95), and ORR in the cetuximab group (OR 1.39, 1.22-1.58). In subgroup analysis, in colorectal cancer, there was a significant improvement of PFS (0.72, 0.66-0.78), OS (0.90, 0.81-1.00), and ORR in the cetuximab group (1.36, 1.15-1.60). In head and neck carcinoma, there was a significant improvement of PFS (0.63, 0.54-0.73), OS (0.78, 0.67-0.91), and ORR in the cetuximab group (1.57, 1.15-2.16). In non-small-cell lung cancer, there was a significant improvement of OS (0.86, 0.76-0.96) in the cetuximab group, and no difference on PFS (0.82, 0.64-1.07) and ORR (1.56, 0.85-2.88). In pancreatic cancer, there was no difference on PFS (1.11, 0.97-1.28), OS (1.07, 0.93-1.25), and ORR (0.94, 0.66-1.33). There were higher incidences of grade 3-4 toxicity (OR 1.84), skin-related toxicity (OR 31.80), acneiform rash (OR 30.14), and hypomagnesemia (OR 6.72) in the cetuximab group.
Cetuximab-based therapy improved PFS and OS, and better ORR versus non-cetuximab therapy. The severe adverse events should be predictable and manageable.
评估西妥昔单抗为基础的治疗与非西妥昔单抗治疗晚期癌症的疗效和安全性。
共纳入来自 17 项随机对照试验的 7954 例患者,西妥昔单抗组 3965 例,非西妥昔单抗组 3989 例。结局指标为无进展生存期(PFS)、总生存期(OS)、总缓解率(ORR)和 3/4 级不良事件。
西妥昔单抗组 PFS(HR 0.83,95%CI 0.78-0.88)、OS(HR 0.89,0.84-0.95)和 ORR(OR 1.39,1.22-1.58)显著改善。亚组分析显示,在结直肠癌中,西妥昔单抗组 PFS(0.72,0.66-0.78)、OS(0.90,0.81-1.00)和 ORR(1.36,1.15-1.60)显著改善。在头颈部癌中,西妥昔单抗组 PFS(0.63,0.54-0.73)、OS(0.78,0.67-0.91)和 ORR(1.57,1.15-2.16)显著改善。在非小细胞肺癌中,西妥昔单抗组 OS(0.86,0.76-0.96)显著改善,PFS(0.82,0.64-1.07)和 ORR(1.56,0.85-2.88)无差异。在胰腺癌中,PFS(1.11,0.97-1.28)、OS(1.07,0.93-1.25)和 ORR(0.94,0.66-1.33)无差异。西妥昔单抗组 3/4 级毒性(OR 1.84)、皮肤相关毒性(OR 31.80)、痤疮样皮疹(OR 30.14)和低镁血症(OR 6.72)的发生率较高。
与非西妥昔单抗治疗相比,西妥昔单抗为基础的治疗可改善 PFS 和 OS,且 ORR 更高。严重不良事件是可预测和可管理的。