Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 

 Table of Contents  
ORIGINAL ARTICLE
Year : 2014  |  Volume : 10  |  Issue : 5  |  Page : 70-74

Shenqifuzheng injection combined with chemotherapy in the treatment of advanced gastric cancer: A systematic review and meta-analysis


1 Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng, China
2 Department of Nephrology, Huaihe Hospital of Henan University, Kaifeng, China

Date of Web Publication30-Aug-2014

Correspondence Address:
Xuequn Ren
Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng - 475 000
China
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.139768

Rights and Permissions
 > Abstract 

Objective: The aim of this systematic review and meta-analysis was to evaluate the clinical efficacy of Shenqifuzheng (SQFZ) injection combined with chemotherapy in the treatment of advanced gastric cancer.
Materials and Methods: We conducted an electronic search by using PubMed, EMBASE, ASCO, ESMO and Chinese National Knowledge Infratructure (CNKI), databases. The randomized controlled trials about Shenqifuzheng injection combined with chemotherapy versus chemotherapy alone in the treatment of advanced gastric cancer were reviewed and collected. Pooled odds ratio (OR) for the response rate and KPS improvement were calculated using the software MetaAnalyst 3.1.
Results: Fifteen trials met our inclusion criteria and finally included in this meta-analysis. The objective response rate (ORR) in patients treated with Shenqifuzheng injection combined with chemotherapy was much higher than that of chemotherapy only (OR = 1.66, 95% CI: 1.20-2.29) with statistical significance (P < 0.05). The pooled data showed the combined treatment can significant increase the Karnofsky score (KPS) compared with the chemotherapy only (OR = 3.74, 95% CI: 2.66-5.27 (P < 0.05).
Conclusion: SQFZ injection combined with chemotherapy treatment regimen can improve the clinical efficacy and performance status in patients with advanced gastric cancer compared with chemotherapy alone.

Keywords: Advanced gastric cancer, advanced gastric cancer, meta-analysis, chemotherapy, shenqifuzheng injection


How to cite this article:
Yao K, Ma Y, Ma W, Hu J, Wang C, Chen J, Zhang J, Hua L, Ren X. Shenqifuzheng injection combined with chemotherapy in the treatment of advanced gastric cancer: A systematic review and meta-analysis. J Can Res Ther 2014;10, Suppl S1:70-4

How to cite this URL:
Yao K, Ma Y, Ma W, Hu J, Wang C, Chen J, Zhang J, Hua L, Ren X. Shenqifuzheng injection combined with chemotherapy in the treatment of advanced gastric cancer: A systematic review and meta-analysis. J Can Res Ther [serial online] 2014 [cited 2020 Feb 29];10:70-4. Available from: http://www.cancerjournal.net/text.asp?2014/10/5/70/139768


 > Introduction Top


Gastric cancer is one of the leading cause worldwide. It was reported that about 989,600 new stomach cancer cases and 738,000 deaths were estimated to have occurred in 2008, accounting for 8% of the total cases and 10% of total deaths. [1] Over 70% of new cases and deaths occur in developing countries [1] especially in China. According to two national mortality surveys conducted in 1973-1975 and 1990-1992, organized by the National Office for Cancer Prevention of Control, the mortality rates of gastric cancer was relative high and stomach cancer was still the major cause of cancer related death in China. [2]

Recent statistics demonstrated that stomach cancer rates have decreased substantially in most parts of the world, [1] in part due to factors related to the increased use and availability of refrigeration including the increased availability of fresh fruits and vegetables, and a decreased reliance on salted and preserved foods. Other major determinants for the favorable trends are reductions in chronic Helicobacter pylori infection in most parts of the world and smoking in some parts of the developed world. [1]

Early stage stomach cancer can be treated with surgery with acceptable prognosis, but advanced gastric cancer in general lose the opportunity of operation which should be treated by chemotherapy or radiotherapy. The general aim of systematic chemoradiation was to prolong the life expectancy and improve the quality of life. Senqifuzheng (SQFZ) injection was extracted from Codonopsis pilosula and astragali which was generally used to improve the immune system of patients with several types of carcinoma, including non-small cell lung cancer (NSCLC), stomach carcinoma, liver cancer etc. [3],[4] Several trials have demonstrated that the SQFZ injection combined with systematic chemotherapy can increase the objective response rate and improve the quality of life. But the small number in each study made the clinical evidence limitation. Thus, we performed this systematic meta-analysis to evaluate the clinical efficacy of SQFZ injection combined with chemotherapy in the treatment of advanced gastric cancer.


 > Materials and methods Top


Search strategy

Two authors searched the databases independently. The studies comparing SQFZ injection combined with chemotherapy versus chemotherapy alone, published before May 2014, were reviewed and collected from the databases of European Society of Medical Oncology (ESMO) and the conference proceedings of the American Society of Clinical Oncology (ASCO), the Cochrane central register of controlled trials, EMBASE and Chinese National Knowledge Infrastructure (CNKI) databases. The search terms were "gastric carcinoma/gastric cancer/stomach cancer/stomach carcinoma", "chemotherapy","Shenqifuzheng". Searches were limited to human trials, with the language restriction of English and Chinese.

Data extraction and quality assessment

Two investigators extract the general information from each individual study independently. Any dispute was solved via discussion. Only if both investigators approved the study that it could be included in this meta-analysis. Characteristics of the study including first author name, publication time, number of subjects in each arm, treatments regimen and jaded score of each trials were extracted from each study. The summary of methodological quality was evaluated using a four-question instrument Jadad score system with a full score of 7. The four-question were randomization, concealment of allocation, double blinding and withdrawals and drops. The trial quality was deemed as high with score of 4-7 and low with score of 0-3.

Response criteria

According to the Response Evaluation Criteria in Solid Tumors (RECST) developed by the World Health Organization (WHO), [5] the tumor response were divided to complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). The objective response rate (ORR) was definite as CR + PR. And the exact definition for CR, PR, SD and PD was as follows:

  • Complete Response (CR): Disappearance of all target lesions
  • Partial Response (PR): At least a 30% decrease in the sum of the Longest diameter (LD) of target lesions, taking as reference the baseline sum LD
  • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
  • Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.


Statistical analysis

MetaAnalyst 3.13 was used to do the statistical analysis. Dichotomous data are calculated as the odd ratio (OR) with the 95% confidence interval (CI). The primary end points of this meta-analysis was OR of objective response rate and KPS improvement. Statistical heterogeneity of the results across trials was assessed by Chi-square (χ2 ) test, [6] and the inconsistency was calculated by I 2 . [7] If heterogeneity was found (χ2 , I 2 > 50%), the random-effect method (Dersimonian-Laird method) was used to pool the data and subgroups analysis was done for further evaluation. Inversely, without significant heterogeneity, fixed-effect method was used. The funnel plots were used for evaluation possible publication bias.


 > Results Top


Included trials and characteristics

We firstly identified 236 potentially relevant potential trials from electronic database searching. By excluding the inappropriate studies, 15 trials [8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22] were finally included in this meta-analysis. The general characteristics of the included studies were demonstrated in [Table 1].
Table 1: The general characteristics of included trials


Click here to view


The summary of methodological quality was evaluated using a four-question instrument Jadad score system with a full score of 7. In this meta-analysis, the median Jadad score was 3.0 which demonstrated the general quality of the included studies was relative low, [Table 1].

Objective response rate

Ten articles included in this meta-analysis provided the individual objective rate. In the combined treatment regimen group, 176 subjects reached CR or PR, with and median ORR of 56.6%. In the chemotherapy alone group, 121 cases reached CR or PR, with and median ORR of 42.9%. The pooled data shows that the ORR in patients treated with SQFZ injection combined with chemotherapy was much higher than that of chemotherapy only (OR = 1.66, 95% CI: 1.20-2.29) with statistical significance (P < 0.05) [Figure 1].
Figure 1: Forest plot for objective response rate

Click here to view


KPS score improvement

In the combined treatment group, KPS score improved more than 10 points was observed in 428 subjects and in the chemotherapy alone group, the number of KPS score improved more than 10 points was 263. The pooled data showed the combined treatment can significant increase the KPS score compared with the chemotherapy only (OR = 3.74, 95% CI: 2.66-5.27, P < 0.05) [Figure 2].
Figure 2: Forest plot for KPS improvement

Click here to view


Publication bias

No evidence of publication bias was found according to the shape of funnel plots [Figure 3].
Figure 3: Funnel plot for evaluation the publication bias (a: ORR; b: KPS)

Click here to view



 > Discussion Top


In this meta-analysis, we finally included 15 trials about SQFZ injection plus chemotherapy regimen versus chemotherapy only in the treatment of advance gastric cancer. Of the included 15 studies, 11 trials presents the individual data for complete response and partial response which could be drawn for further calculation of pooled ORR. And 12 studies providing the data of performance status improve rate which could be extracted for evaluation of pooled OR for improvement of KPS rate. For ORR, the pooled results of the 15 trials demonstrated that the ORR in patients treated with SQFZ injection combined with chemotherapy was much higher than that of chemotherapy only (OR = 1.66, 95% CI: 1.20-2.29) with statistical significance (P < 0.05); For KPS improvement, the pooled data showed the combined treatment can significant increase the KPS score compared with the chemotherapy only (OR = 3.74, 95% CI: 2.66-5.27, P < 0.05). The pooled results of this meta-analysis indicated that SQFZ injection combined with chemotherapy treatment regimen can improve the clinical efficacy and performance status in patients with advanced gastric cancer compared with chemotherapy alone.

SQFZ injection was extracted from Codonopsis pilosula and Astragali which was generally used to improve the immune system of patients with several types of carcinoma, including non-small cell lung cancer, stomach carcinoma, liver cancer and et al. [3],[4] According to most studies included in this meta-analysis, patients in the combined treatment group generally benefit much from receiving SQFZ compared with the patients who does not received the SQFZ injection. This results indicated that SQFZ injection could improve the recent clinical efficacy and improve the quality. As known, the gold standard for evaluation the treatment regiments efficacy was overall survival (OS) and disease free survival (DFS). But in this meta-analysis, for lacking of long-term follow up data of each individual trials, the pooled results for OS and DFS could not be calculated. And another drawbacks of this study was the relative low quality of each individual trials included in this meta-analysis. The median score for each study was only three which demonstrated the methodology quality was relative poor. The relative low quality of each trial made the pooled results limitation. Thus, the general methodological quality for performing the prospective randomized controlled trials should be improved in the future clinical trials associated traditional Chinese medicine.

 
 > References Top

1.Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011;61:69-90.  Back to cited text no. 1
    
2.Chen KX, Wang PP, Zhang SW, Li LD, Lu FZ, Hao XS. Regional variations in mortality rates of pancreatic cancer in China: Results from 1990 - 1992 national mortality survey. World J Gastroenterol 2003;9:2557-60.  Back to cited text no. 2
    
3.Huang WL. Clinical study on primary liver cancer treated by shen qi fu zheng injection combined interventional therapy. Guide Chin Med 2011;20:2.  Back to cited text no. 3
    
4.Yao DJ, Chen Y. A clinical study of Shenqifuzheng injection combined with GP chemotherapy regimen in the treatment of advanced non-small cell lung cancer. Chin J Clin Res 2013:1378-9.  Back to cited text no. 4
    
5.Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clin Cancer Res 2009;15:7412-20.  Back to cited text no. 5
    
6.DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7:177-88.  Back to cited text no. 6
[PUBMED]    
7.Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327:557-60.  Back to cited text no. 7
    
8.Liu H, Han D. Effects of Shenqifuzheng injection on the immunolologic function and clinic efficacy in the elderly patients with advanced gastric cancer. J Chin Pharmacol 2011;27:177-83.  Back to cited text no. 8
    
9.Jia JW, Liu YQ. The E‡Ubct of Shenqi Fuzheng Injection Combined with FoLFoX4 Regimen in the Treatment of Advanced Gastric Cancer. Pract J Cancer 2009;3:273-5.  Back to cited text no. 9
    
10.Zhou KX, Wang JH, Liu BK, Zhou CY, Xin M, Zhi JL, et al. Clinical study on effect of shenqi fuzheng injection combined with chemotherapy in treating gastric cancer. Chin J Integr Trad Western Med 1999;1:1-6.  Back to cited text no. 10
    
11.Xiong W. A clinical study of SQFZ injection combined with DCF chemotherapy regimen in the treatment of advanced gastric carcinoma. Guangming J Chin Med 2010;25:635-6.  Back to cited text no. 11
    
12.Wan LX, Wang Y. Shenqifuzheng injection combined with FOLFOX4 chemotherapy regimen in the treatment of advanced stomach cancer. J Med Forum 2006;27:96-7.  Back to cited text no. 12
    
13.Li ZY, Huang QH, Xu HS, Ruan XF. A clinical observation of Shenqifuzheng injection combined with chemotherapy in the treatment of gantric cancer. J Liaoning Univ Trad Chin Med 2006;8:89-90.  Back to cited text no. 13
    
14.Zhao JM, Wu AZ, Shi LR, Yang XX, Li J, Wu CP. CIinicaI treatment of advanced gastric cancer by combined use of shenqi fuzheng injection, ocetaxel, fiurouracil and calcium folinate. Chin J Integr Med 2007;27:736-8.  Back to cited text no. 14
    
15.Zhu LF, Zhang YS, Wu Q. A clinical study of Shenqifuzheng injection combined with chemotherapy in the treatmento of gastric cancer. Shanghai Med J 2007;30:542-3.  Back to cited text no. 15
    
16.Chen M, Zhang P. Shenqifuzheng injection combined with chemotherapy in the treatment of gastric cancer patients who recied surgery. Chin Commun Doct 2010;12:113-4.  Back to cited text no. 16
    
17.Fang XY. Observation of efficacy of Shenqi Fuzheng injection combined witIl FOLFOX4 chemotherapy in treatment of advanced gastric cancer. Chin J Pract Med 2010;37:23-4.  Back to cited text no. 17
    
18.Zhang WH, Wang J, Tan YQ, Yuan XR, Liu CX. Shenqifuzheng injection combined with chemotherapy in the treatment of eldder gastric patients: A clinical study with 30 cases. J Baotou Med Coll 2012;28:86-7.  Back to cited text no. 18
    
19.Wang M, Lin HJ. Efficacy observation of ShenqiFuzheng injection combined with FOLFOX4 chemotherapy in treatment of advanced gastric cancer. Chin Modern Med 2011;18:89-90.  Back to cited text no. 19
    
20.Luo PF. A clinical study of Shenqifuzheng injection combined with chemotherapy in the treatment of advanced gastric carcimona. Modern Med Health 2011;27:1170-1.  Back to cited text no. 20
    
21.Pa TM, Gu LZ. Clinical observation of Shenqifuzheng injection combined with FOLFOX4 regimen in the treatment of advanced gastric cancer. World Latest Med Inform 2012:46-7.  Back to cited text no. 21
    
22.Ren YZ, Wang F. Infuluece of advanced gastric cancer treatment with Shenqifuzheng injection combined with cheotherapy on effect and immune funtion. J Basic Clin Oncol 2012;25:394-6.  Back to cited text no. 22
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1]



 

Top
 
 
  Search
 
Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
Access Statistics
Email Alert *
Add to My List *
* Registration required (free)

  >Abstract>Introduction>Materials and me...>Results>Discussion>Article Figures>Article Tables
  In this article
>References

 Article Access Statistics
    Viewed1487    
    Printed67    
    Emailed2    
    PDF Downloaded62    
    Comments [Add]    

Recommend this journal


[TAG2]
[TAG3]
[TAG4]