Wang Chuan, Liu Min, Li Zhongdong
2016, 18(1): 19.
ObjectiveTo evaluate the incidence of equal to or greater than grade 3 adverse reactions of cetuximab combined with chemotherapeutic drugs or only chemotherapeutic drugs in treatment of patients with advanced colorectal cancer (ACRC)or metastatic colorectal cancer (mCRC).MethodsThe databases of MEDLINE, PubMed, Embase, Cochrane Library, China National Knowledge Infrastruc-ture, Wanfang Database and Vip Database from the inception to September 2014 were searched. The randomized controlled trial (RCT) which were about cetuximab combined with chemotherapy drugs (experimental group) or only chemotherapy drugs (control group) in treatment of patients with ACRC or mCRC were collected. The software of Review Manager 5.3 was used for meta-analysis. The incidence of equal to or greater than grade 3 adverse reactions of cetuximab combined with chemotherapy drugs or only chemotherapy drugs between the two groups were compared. The results were shown by odds ratio (OR) and 95% confidence intervals (CI).ResultsA total of 14 papers were enrolled into this Meta-analysis. There were 9 RCTs without the blinding design, 3 RCTs without the number of lost and 2 RCTs without the patients' basic information out of the 14 papers. The result of the test of heterogeneity showed no significant heterogeneity among the RCTs. A total of 9 876 patients were enrolled into the Meta-analysis, including 4 927 patients in the experimental group and 4 949 in the control group. The incidence of 9 kinds of ≥3 grade of adverse reactions among the 11 adverse reactions which reported in the 14 papers in the experimental group were higher than those of the control group, such as acneform rash [14.2% (695/4 886) vs. 0.2% (12/4 926), OR=57.03, 95% CI: 33.85-96.10, P<0.001], oral mucositis [5.4% (134/2 466) vs. 1.9% (48/2507), OR=2.97, 95% CI: 2.13-4.16, P<0.001], hand-foot syndrome [7.9% (114/1 439) vs. 3.1% (45/1 436), OR=2.68, 95%CI: 1.88-3.83, P<0.001], anaphylactic reaction [5.2% (102/1 973) vs. 1.9% (39/2 014), OR=2.66, 95%CI: 1.84-3.86, P<0.001], anorexia [4.3% (124/2 878) vs. 2.4% (70/2 914), OR=1.82, 95%CI: 1.35-2.45, P<0.001], diarrhea [17.9% (876/4886) vs. 12.6%(539/4926), OR=1.80, 95% CI: 1.60-2.02, P<0.001], fatigue [6.4% (242/3 793) vs. 4.2% (162/3 818), OR=1.53, 95% CI: 1.24-1.87, P<0.001], nausea and vomiting [8.4% (380/4 548) vs. 7.1% (325/4 590), OR=1.22, 95%CI: 1.04-1.42, P<0.001], and leucopenia [17.8% (869/4 886) vs. 16.1% (794/4 926), OR=1.14, 95%CI: 1.02-1.27, P=0.02]. There was no significant difference in the incidence of anemia between the experiment group and the control group [2.6% (33/1 258) vs. 2.4% (29/1 231), OR=1.11, 95% CI: 0.68-1.83, P=0.67]. The incidence of peripheral neuropathy in the experiment group was lower than that in the control group[10.5% (170/1 620) vs. 14.7% (237/1 608), OR=0.67, 95%CI: 0.54-0.83, P<0.001]. The sensibility analysis showed the above-mentioned results were steady and dependable. ConclusionComparison with only using chemotherapeutic drugs in treatment of patients with ACRC or mCRC, cetuximab combined with chemotherapy drugs may increase the incidence of ≥ 3 grade adverse reactions except severe anemia and severe peripheral neuropathy.