Abstract

Background Cinobufacin is a Chinese patent medicine widely used for breast cancer in China. However, no systematic review and meta-analysis have been published to validate its effects in breast cancer treatment. We, therefore, summarize the efficacy and safety of Cinobufacin combined with chemotherapy in order to provide rigid evidence for its clinical application. Methods By searching multiple databases incepted to December 2019, the RCTs of breast cancer patients treated with Cinobufacin were screened according to the inclusion criteria, and the meta-analysis and sensitivity analysis were conducted using RevMan5.3. Results A total of 1163 articles were retrieved, and 16 studies were included. The total sample size was 1331 cases, including 666 cases in the treatment group receiving Cinobufacin combined with chemotherapy and 665 cases in the control group receiving chemotherapy alone. Our study found that the ORR (overall response rate) (RR = 1.35, 95% CI: [1.23, 1.49], P < 0.00001), CBR (clinical benefit rate) (RR = 1.14, 95% CI: [1.08, 1.21], P < 0.00001), KPS scores (RR = 1.98, 95% CI: [1.45, 2.68], P < 0.0001), and pain relief rate (RR = 1.34, 95% CI: [1.01, 1.78] P=0.04 of the Cinobufacin combined with chemotherapy group were better than those of the chemotherapy group, and the difference was statistically significant. Our study also discovered that the tumor markers (CA125, CA153, and CEA) in the Cinobufacin combined with chemotherapy group were lower than those in the chemotherapy group, which heterogeneity was derived from the low-quality literature included in the study, but the results were robust. In addition, in terms of safety, we found that the incidences of gastrointestinal reactions (RR = 0.58, 95% CI: [0.48, 0.70], P < 0.00001), liver and kidney damage (RR = 0.57, 95% CI: [0.38, 0.84], P=0.004), and hair loss (RR = 0.61, 95% CI: [0.40, 0.92], P=0.02) in the Cinobufacin combined chemotherapy group were lower than those in the chemotherapy group, and the difference was statistically significant, but the incidences of peripheral neurotoxicity (RR = 0.69, 95% CI: [0.26, 1.85], P=0.46) and myelosuppression (RR = 0.78, 95% CI: [0.46, 1.34], P=0.37) in the combined group were similar to those of the chemotherapy group, and the difference was not statistically significant. Conclusions Cinobufacin combined with chemotherapy can improve the clinical efficacy of breast cancer patients, enhance the quality of life of the patients, reduce the value of tumor markers such as CA125, CA153, and CEA, and lower the occurrence of adverse reactions such as gastrointestinal reactions, liver and kidney damage, and hair loss.

Highlights

  • Breast cancer is the malignant tumor with the highest female morbidity and the second highest mortality after lung cancer in the world

  • Tumor Markers. e six studies [13, 14, 18, 20, 26, 28] were reported the changes of CA153 and CEA, of which 4 studies [14, 18, 20, 26] reported changes in CA125. rough a comparative analysis of tumor markers before and after treatment in 1372 patients, we found that the heterogeneity between CA125, CA153, and CEA groups before treatment was relatively small and the fixed effects model was selected for meta-analysis. e results showed that there was no statistical difference in tumor markers before treatment (P > 0.05) (Figure 6)

  • The meta-analysis method was used to merge and analyze 16 randomized controlled literature studies on the efficacy and safety of Cinobufacin combined with chemotherapy for breast cancer. e results of meta-analysis showed that the overall response rate (ORR), clinical benefit rate (CBR), Karnofsky Performance Status CR (KPS) scores, and pain relief rate of the Cinobufacin combined with chemotherapy group were better than those of the chemotherapy-alone group, which suggested that Cinobufacin combined with chemotherapy could improve the clinical efficacy and quality of life of the patients with breast cancer

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Summary

Introduction

Breast cancer is the malignant tumor with the highest female morbidity and the second highest mortality after lung cancer in the world. Chemotherapy is one of the commonly used treatment methods for advanced breast cancer, Evidence-Based Complementary and Alternative Medicine but its application is limited because of its severe side effects, including gastrointestinal symptoms, myelosuppression, liver and kidney damage, etc [3]. Erefore, we carried out a meta-analysis of Cinobufacin based on the RCT literature of breast cancer to evaluate the efficacy and safety of its treatment and to provide guidance for the clinical application of Cinobufacin. Cinobufacin combined with chemotherapy can improve the clinical efficacy of breast cancer patients, enhance the quality of life of the patients, reduce the value of tumor markers such as CA125, CA153, and CEA, and lower the occurrence of adverse reactions such as gastrointestinal reactions, liver and kidney damage, and hair loss

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