Abstract

Huaier Granule, a type of traditional Chinese biomedical preparation (TCBP), is considered to be a promising adjuvant therapy for breast cancer. Although an analysis of the published literature has been performed, the exact effects and safety of Huaier Granule remains controversial. Therefore, a wide-ranging systematic search of electronic databases from which to draw conclusions was performed. Data from 27 trials, including 2562 patients with breast cancer were analyzed. The results indicated that, compared with conventional treatment alone, the combination of conventional treatment and Huaier Granule markedly improved patients’ overall response (P=0.02) and quality of life (P<0.00001), and significantly prolonged 2-year (P=0.02), 3-year (P<0.0001) and 5-year (P=0.004) overall survival rates, and 1-year (P=0.003), 2-year (P<0.00001), 3-year (P<0.00001) and 5-year (P=0.03) disease-free survival. The immune function of patients was also significantly enhanced after combined intervention treatment, indicated by clearly increased percentages of CD3+ (P=0.05), CD4+ (P<0.00001) and natural killer cells (P<0.0001), and CD4+/CD8+ ratio (P<0.00001). The incidence of myelosuppression (P=0.001) and hepatotoxicity (P=0.05) was lower in breast cancer patients treated with Huaier Granule, whereas other adverse events did not differ significantly between the two groups (P>0.05). In summary, results of this meta-analysis suggest that the combination of conventional treatment and Huaier Granule is more effective for the treatment of breast cancer than conventional treatment alone.

Highlights

  • Breast cancer is the second most common cancer and the fourth leading cause of cancer-related deaths worldwide [1,2]

  • Huaier Granule was manufactured by Qidong Gaitianli Pharmaceutical Co., Ltd, and granted a manufacturing approval number issued by the Chinese State Food and Drug Administration (SFDA) (Z20000109)

  • The study assessed whether Huaier Granule could prolong the long-term survival rates of breast cancer patients, and the results showed that the 2, 3and 5-year Overall survival (OS) and 1, 2, 3- and 5-year disease-free survival (DFS) of patients were all significantly prolonged compared with the control group

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Summary

Introduction

Breast cancer is the second most common cancer and the fourth leading cause of cancer-related deaths worldwide [1,2]. It was estimated that 2,088,849 new cases (11.6% of all sites) of breast cancer and 626,679 (6.6% of all sites) breast cancer-related deaths occurred worldwide in 2018 [1,2]. Due to the negligence of women regarding the self-inspection and clinical examination of the breast, early detection of breast cancer remains difficult [3,4]. In patients who have been identified with breast tumor, different strategies of management are used such as hormonal therapy, radiation therapy, surgery and chemotherapy [4–8]. It is known that the above conventional treatment methods often fail to remove the tumor completely [9,10]. The unpleasant side effects of breast cancer treatment are one of the most motivating factors to find some alternative methods [9,10]

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