| Purpose:To systematically review the effectiveness and safety of sorafenib versus immunotherapy or evaluate the efficacy and safety of sorafenib plus immunotherapy versus sorafenib alone in patients with advanced renal cell carcinoma.Methods:Databases including The Cochrane Library, PubMed, Web of Science, CBM, CNKI, VIP and WanFang Data were electronically searched from inception to Feb.2014, for the randomized controlled trials (RCTs) on sorafenib versus immunotherapy and sorafenib plus immunotherapy versus sorafenib alone for advanced renal cell carcinoma. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality. Then, systematic review was performed using RevMan 5.0 software.Result:Finally,8 studies were included involving 674 patients. The results of meta-analysis showed that, ① Compared with immunotherapy, sorafenib demonstrate greater clinical benefit in terms of PFS[MD=1.46,95% CI (0.07,2.85), P=0.04]. There were no statistically differences in overall effective rate[OR=1.53,95%CI (0.93,2.51), P=0.09] and control rate[OR=1.42,95%CI (0.41,4.91), P=0.58]. In common adverse events(fatigue, diarrhea, nausea+vomiting, hand-foot skin reaction), the incidence of nausea+vomiting in sorafenib group was lower than immunotherapy group. However, there were no statistical significance in other adverse events.② There were no statistical differences between sorafenib plus immunotherapy and sorafenib alone on overall effective rate[OR=1.40,95%CI (0.75,2.61), P=0.29], control rate[OR=1.70,95%CI(0.99,2.94),P=0.06] and adverse events rate[OR=1.12,95%CI (0.32,3.92), P=0.85].Conclusions:Based on current clinical evidence, there was a significant prolongation of PFS in sorafenib-treated patients with advanced renal cell carcinoma comparing with the immunotherapy, and the combination therapy was not superior to the monotherapy. |
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