Efficacy and safety of Shenqi Fuzheng injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer

Abstract Background: Shenqi Fuzheng injection (SFI) is a commonly used anti-cancer Chinese patent medicine and has long been prescribed as adjunctive treatment to platinum-based chemotherapy (PBC) in patients with stage III/IV non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy remain unclear. Methods: A systematic review and meta-analysis will be conducted following the Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Seven databases will be searched for relevant studies from their inception to the present date: PubMed, Web of Science, Cochrane Library, EMBASE, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI), and Wanfang Databases. All randomized clinical trials comparing SFI in combination with PBC versus PBC alone will be retrieved and assessed for inclusion. Two researchers will independently perform the selection of the studies, data extraction, and synthesis. The Cochrane Risk of Bias Tool will be used to evaluate the risk of bias of the RCTs. The primary endpoint is the disease control rate (DCR), the secondary outcomes are the objective response rate (ORR), survival rate, quality of life (QOL), cellular immune function, and toxicities. Review Manager 5.3 (Nordic Cochrane Centre, Cochrane Collaboration, 2014 Copenhagen, Denmark) will be used to analyze the outcomes. Results: This study will systematically evaluate the efficacy and safety of SFI combined with platinum-based chemotherapy in the treatment of stage III/IV NSCLC. The results will be published in a peer-reviewed journal. Conclusion: This systematic review will evaluate the effects of SFI as adjunctive treatment to platinum-based chemotherapy in the patients with stage III/IV non-small cell lung cancer, thus providing evidence to the clinical application of this combination therapy. PROSPERO registration number: CRD42019137196

[1]  Xinbing Sui,et al.  Elemene injection as adjunctive treatment to platinum-based chemotherapy in patients with stage III/IV non-small cell lung cancer: A meta-analysis following the PRISMA guidelines. , 2019, Phytomedicine : international journal of phytotherapy and phytopharmacology.

[2]  C. Gridelli,et al.  Diagnosis and first-line treatment of non-small cell lung cancer in the era of novel immunotherapy: recommendations for clinical practice , 2019, Expert review of respiratory medicine.

[3]  E. Leung,et al.  Concurrent use of herbal products with prescription drugs is a double-edged sword and evidence-based medicine contributes to reshaping the practice. , 2019, Pharmacological research.

[4]  Jiarui Wu,et al.  Shenqi Fuzheng Injection in the Treatment of Breast Cancer: A Meta-analysis of Randomized Controlled Trials , 2018, Integrative cancer therapies.

[5]  Qiuyu Zhao,et al.  Shenqi Fuzheng Injection Reverses Cisplatin Resistance through Mitofusin-2-Mediated Cell Cycle Arrest and Apoptosis in A549/DDP Cells , 2018, Evidence-based complementary and alternative medicine : eCAM.

[6]  A. Jemal,et al.  Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries , 2018, CA: a cancer journal for clinicians.

[7]  Yan Li,et al.  ShenQi FuZheng Injection combined with chemotherapy in the treatment of colorectal cancer: A meta-analysis , 2017, PloS one.

[8]  P. Tagliaferri,et al.  Systemic therapy treatment patterns in patients with advanced non‐small cell lung cancer (NSCLC): PIvOTAL study , 2017, European journal of cancer care.

[9]  Wang Xiaoying,et al.  Immunoregulation of Shenqi Fuzheng Injection Combined with Chemotherapy in Cancer Patients: A Systematic Review and Meta-Analysis , 2017, Evidence-based complementary and alternative medicine : eCAM.

[10]  Xiu-qiong Fu,et al.  In vitro assays suggest Shenqi Fuzheng Injection has the potential to alter melanoma immune microenvironment. , 2016, Journal of ethnopharmacology.

[11]  D. Cao,et al.  The Effect of ShenQi FuZheng Injection in Combination with Chemotherapy versus Chemotherapy Alone on the Improvement of Efficacy and Immune Function in Patients with Advanced Non-Small Cell Lung Cancer: A Meta-Analysis , 2016, PloS one.

[12]  A. Jemal,et al.  Cancer statistics in China, 2015 , 2016, CA: a cancer journal for clinicians.

[13]  Lu Wang,et al.  Development and optimization of SPE-HPLC-UV/ELSD for simultaneous determination of nine bioactive components in Shenqi Fuzheng Injection based on Quality by Design principles , 2016, Analytical and Bioanalytical Chemistry.

[14]  Guijuan Zhang,et al.  Shenqi Fuzheng Injection Combined with Chemotherapy for Breast Cancer: A Meta-Analysis of Randomized Controlled Trials , 2015, Evidence-based complementary and alternative medicine : eCAM.

[15]  Y. Liu,et al.  Anti-Tumor Effect of Steamed Codonopsis lanceolata in H22 Tumor-Bearing Mice and Its Possible Mechanism , 2015, Nutrients.

[16]  Yanming Xie,et al.  Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici). , 2014, Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan.

[17]  W. Su,et al.  Bioactive components on immuno-enhancement effects in the traditional Chinese medicine Shenqi Fuzheng Injection based on relevance analysis between chemical HPLC fingerprints and in vivo biological effects. , 2014, Journal of ethnopharmacology.

[18]  Long Hua,et al.  Shenqifuzheng injection combined with chemotherapy in the treatment of advanced gastric cancer: a systematic review and meta-analysis. , 2014, Journal of cancer research and therapeutics.

[19]  M. Keane,et al.  Effect of chemotherapy on quality of life in patients with non-small cell lung cancer , 2014, Supportive Care in Cancer.

[20]  M. Walker,et al.  Interventions to reduce dependency in personal activities of daily living in community-dwelling adults who use homecare services: protocol for a systematic review , 2013, Systematic Reviews.

[21]  Elie A Akl,et al.  GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes. , 2013, Journal of clinical epidemiology.

[22]  Satomu Morita,et al.  Tubular nephrotoxicity induced by docetaxel in non-small-cell lung cancer patients , 2012, International Journal of Clinical Oncology.

[23]  Peter M. Ellis,et al.  First-Line Systemic Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer: A Systematic Review , 2010, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[24]  Xiqiao Zhou,et al.  The efficacy and safety of tiotropium in Chinese patients with stable chronic obstructive pulmonary disease: A meta‐analysis , 2009, Respirology.

[25]  Zhiguo Ding,et al.  [Effects of Shenqi Fuzheng injection on gene expression profile of liver tissue with metastatic carcinoma in mice]. , 2008, Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine.

[26]  R. Govindan,et al.  Trends in Stage Distribution for Patients with Non-small Cell Lung Cancer: A National Cancer Database Survey , 2010, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[27]  B. Lahiri,et al.  Preoperative evaluation of patients undergoing lung resection surgery. , 2003, Chest.

[28]  G. Smith,et al.  Bias in meta-analysis detected by a simple, graphical test , 1997, BMJ.

[29]  C. Begg,et al.  Operating characteristics of a rank correlation test for publication bias. , 1994, Biometrics.

[30]  A. Jemal,et al.  Cancer statistics, 2018 , 2018, CA: a cancer journal for clinicians.

[31]  Yang Lu,et al.  Inhibitory effect of Shenqi Fuzheng injection combined with docetaxel on lung cancer cells , 2017, Journal of Zhejiang University-SCIENCE B.

[32]  A. Jemal,et al.  Global Cancer Statistics , 2011 .