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 Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 11  |  Issue : 3  |  Page : 558-564

A meta-analysis of Kang`ai injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer


1 Graduate School of Beijing University of Chinese Medicine; Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
2 Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

Date of Web Publication9-Oct-2015

Correspondence Address:
Hongsheng Lin
Chief Physician, Doctoral Tutor, Chief Researcher in China Academy of Chinese Medical Sciences, Xi Cheng-100 053, Beijing
China
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Source of Support: The Traditional Chinese Medicine Industry Scientific Research (No. 201307006), Conflict of Interest: None


DOI: 10.4103/0973-1482.158034

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 > Abstract 

Objective: The purpose of this study was to evaluate the Kang`ai injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC) by meta-analysis.
Materials and Methods: Electronic search of the Cochrane library, PubMed, EMBASE, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), and Wanfang Database was conducted to collect appropriate studies about Kang`ai injection combined with chemotherapy versus chemotherapy alone in the treatment of NSCLC. All data were analyzed by using RevMan 5.2 software provided by Cochrane, which involved the odds ratio (OR) and 95% confidence intervals (95% CIs) calculated with fixed-effect models according to the heterogeneity test.
Results: Eighteen studies were included in this meta-analysis. The meta-analysis showed that Kang`ai injection combined with chemotherapy could enhance the efficacy of the tumor response (OR = 1.51, 95% CI: 1.23-1.85, Z = 3.94, P < 0.0001), improve the quality of life (OR = 3.37, 95% CI: 2.71-4.20, Z = 10.86, P < 0.00001), alleviate the adverse reaction of digestive tract (OR = 0.42, 95% CI: 0.32-0.55, Z = 6.34, P < 0.00001) and reduce the risk of the bone marrow suppression (OR = 0.38, 95% CI: 0.29-0.49, Z = 7.37, P < 0.00001) compared with chemotherapy alone. Asymmetries were observed in funnel plots, which indicated an evidence of publication bias.
Conclusion: Kang`ai injection combined with chemotherapy can enhance the short-term efficacy, improve the quality of life, and alleviate the chemotherapy-induced adverse reaction in the treatment of advanced NSCLC, although these results need to be further confirmed by more high-quality trials.

Keywords: Chemotherapy, Kang`ai injection, meta-analysis, non-small cell lung cancer, traditional Chinese medicine


How to cite this article:
Wang X, Lin H, Liyuan L V, Zhang Y, Liu J, Liu Z, Shi H. A meta-analysis of Kang`ai injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer. J Can Res Ther 2015;11:558-64

How to cite this URL:
Wang X, Lin H, Liyuan L V, Zhang Y, Liu J, Liu Z, Shi H. A meta-analysis of Kang`ai injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer. J Can Res Ther [serial online] 2015 [cited 2019 Sep 19];11:558-64. Available from: http://www.cancerjournal.net/text.asp?2015/11/3/558/158034


 > Introduction Top


Nowadays, lung cancer is one of the most common malignancies, whose morbidity and mortality both rank first in the world. [1] According to the biological characteristics, lung cancer can be divided into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). [2] There into; NSCLC is more common, accounting for about 80-85%. [3] Since the signs and symptoms of NSCLC are not obvious in the early stage, most of the cases are usually diagnosed with advanced cancer. In modern medicine, chemotherapy has become the dominant method to cure advanced NSCLC. In China, traditional Chinese medicine (TCM) has been one of the most important methods of treating cancer. A number of researches [4],[5],[6],[7] show that TCM combined chemotherapy can improve the efficacy and reduce the toxicity. Kang`ai injection is one of the representatives in TCM, but little is known about it outside of China. Meanwhile, in China there are still some debates about whether Kang`ai injection can increase the efficacy, improve the quality of life, and reduce the toxicity in the treatment of advanced NSCLC. Thus, we performed this meta-analysis to assess the effectiveness of Kang`ai injection for the treatment of advanced NSCLC in English.


 > Materials and methods Top


Literature source and search strategy

We considered all studies examining the efficacy and safety of combination therapy of Kang`ai injection with chemotherapy for the advanced NSCLC patients. And we searched the following sources up to October 13 th 2014: The Cochrane library, PubMed, EMBASE, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), and Wanfang Database. The searching terms were "lung cancer" or "lung carcinoma" or ""bronchial neoplasms" or "lung neoplasms" or "lung tumor" or "non-small cell lung cancer" or "NSCLC" AND "chemotherapy" AND "Kang`ai injection". The search was done on studies conducted on human subjects without restriction on language.

Inclusion criteria

(i) The study design should be prospective randomized controlled trails (RCTs) with or without blinding. (ii) Patients included in each trails were cytologically or pathologically confirmed cases of NSCLC. (iii) Patient belonging to Stage III or IV. (iv) Karnofsky performance scale (KPS) ≥ 50. (v) Participants in treatment group received combination therapy consisting of Kang`ai injection and chemotherapy and chemotherapy alone in control group. (vi) The control group was only given first-line chemotherapy regimen of National Comprehensive Cancer Network (NCCN). (vii) Reported data on the outcomes at least including tumor response, quality of life (QoL) using the KPS, or the adverse reaction of chemotherapy. (viii) Only adults were included in the clinical trial.

Exclusion criteria

(i) Duplicated publications or overlapping study population. (ii) The postoperative within three months after the operation. (iii) Multiple TCM intervention in the experimental group. (iv) Neoadjuvant chemotherapy. (v) Document of data errors. (vii) Dosage of Kang`ai injection unreasonable. (vii) Less than two cycles of chemotherapy treatment or the period of chemotherapy ambiguous.

Study selection, data extraction, and quality evaluation

The titles and abstracts of potentially eligible studies were screened through the literature search and reviewed independently by two authors, and the disagreements were resolved by discussion or consulting the third reviewer according to the Cochrane handbook. Two authors independently examined full text articles to determine whether they met the inclusion criteria. Meanwhile, the general characteristics such as authors of study, year of publication, sample number of patients included in each arm, treatment of regimen for each arm, tumor response criteria, and outcome measures were extracted. We used Cochrane risk of bias tool to assess the methodological quality of included RCTs. The trails were evaluated by the following six domains: (i) Adequate sequence generation, (ii) allocation concealment, (iii) blinding, (iv) incomplete outcome data addressed, (v) free of selective reporting, and (vi) free of other bias. There are three kinds of judgment given as "high risk", "unclear risk", or "low risk": "low risk" meant trails met all the criteria, "high risk" showed entries met none of the criteria, and "unclear risk" indicated the others were neither "high risk" nor "low risk".

Evaluation criteria

We evaluated the tumor responses of these studies according to Response Evaluation Criteria in Solid Tumors (RECIST) [8] published by World Health Organization (WHO), or according to modified RECIST [9] published in 2000. The tumor responses were divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Tumor response involved cases of CR and PR. We assessed the quality of life by the (KPS. [10] After treatment, we put the results into three types: Improvement, increased by more than 10; deterioration: Reduced by more than 10; and stabilization: Changing within 10. We evaluated the adverse reaction of chemotherapy according to Standard Classification of WHO or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), whose standard classification to the side reaction of digestive tract and the bone marrow suppression almost showed no difference. We evaluated adverse reaction of digestive tract mainly according to the degree of nausea and vomiting. Similarly, we assessed bone marrow suppression mainly based on the degree of leukocyte or neutrophil decreasing.

Statistical method

All data were analyzed with the RevMan 5.2 software provided by Cochrane Collaboration. Dichotomous data were expressed as risk ratio (RR) or odds ratio (OR) and continuous outcomes as weighted mean difference (WMD), with their 95% confidence intervals (CI), respectively. If there was little heterogeneity, we pooled the data using a fixed-effect model (defining heterogeneity test: P > 0.1 or I 2 < 50%); otherwise we used random-effects model (P < 0.1 or I 2 > 50%). [11]


 > Results Top


General characteristics of included trials

The flow chart of our study is shown in [Figure 1]. We identified 305 potential relevant references through database searching. A total of 134 studies were left after removal of duplicated publications. After screening the titles and abstracts, 68 studies were excluded according to inclusion and exclusion criteria. Full texts of 66 papers were retrieved, and finally 18 RCTs were included. These RCTs were conducted in China and published in Chinese. The search for ongoing registered trials identified no trials.
Figure 1: Flow diagram of the study selection procedure. RCT = Randomized controlled trials, NCCN = National Comprehensive Cancer Network

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The detailed characteristics of the 18 RCTs were summarized in [Table 1]. According to the inclusion and exclusion criteria, 18 studies [12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25],[26],[27],[28],[29] including 1,523 cases on Kang`ai injection combined with chemotherapy versus chemotherapy alone in the treatment of advanced NSCLC were finally included in this meta-analysis. The age of participants ranged from 26 to 84 years. The most common chemotherapy regimens were Taxol and platinum, Vinorelbine and platinum, Gemcitabine and platinum, and Docetaxel and platinum; which were the first-line regimen of NCCN. The dosage of Kang`ai injection is 40-60 ml by intravenous injection once a day. The injection was used at the start of chemotherapy or 1 day before it, which was accompanied by chemotherapy. After treatment time of more than two cycles; the tumor response (18 studies), KPS (18 studies), and adverse reaction of chemotherapy mainly including the reaction of digestive tract (12 studies) and bone marrow suppression (14 studies) was evaluated. The tumor response was assessed by two different criteria: Seven trails [12],[13],[14],[15],[16],[17],[18] used RECIST published by WHO, and the other 11 trails [19],[20],[21],[22],[23],[24],[25],[26],[27],[28],[29] used modified RECIST. In addition, none of the trials reported long-term follow-up.
Table 1: Characteristics of included studies

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Methodological quality of included trials

The methodological quality of 18 included trials was demonstrated in [Figure 2] and [Figure 3]. We phoned the authors of the studies when we had something unclear about the trails' details. At last, we only contacted to one author who completed the study. [28] The study was proved to be a RCT of high methodological quality, which was a Phase IV clinical trial (computer generation of random number table, center for random, blinding, and no attrition and reporting bias). The other authors could not be contacted. The methodological quality of the other 17 trials which were only evaluated according to papers was generally low. The 17 included trials all referred to the randomized allocation, but only two trials [15],[18] mentioned the methods of sequence generation of random number table. All of the 17 trials did not mention allocation concealment, double blind, or blinding of outcome assessment. All of the 18 trials did not report any dropout or withdrawal. In addition, since the protocols of the four included trials [14],[25],[26],[27] were not accessible, selective reporting was unclear.
Figure 2: Risk of bias summary: Review authors' judgments about each risk of bias item for each included study. CI = Confidence interval, M-H = Mantel-Haenszel, RECIST = Response Evaluation Criteria in Solid Tumors, KA = Kang`ai injection

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Figure 3: Risk of bias graph: Review authors' judgments about each risk of bias item presented as percentages across all included studies

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Objective tumor response

All the 18 included studies compared the objective tumor response between the treatment and control groups after intervention. Because evaluating criteria were different, this meta-analysis was divided into two subgroups according to modified RECIST and RECIST. All the included trials indicated that homogeneity was in the consistency of their results (χ2 = 9.84, P = 0.91, I 2 = 0%). Thus, the fixed-effects model should be used for statistical analysis. The pooled results showed that objective tumor response was significantly improved in the group of chemotherapy combined with Kang`ai injection compared with chemotherapy alone (n = 1,523, OR = 1.51, 95% CI: 1.23-1.85, Z = 3.94, P < 0.0001). The results of the heterogeneity test and tumor response statistical analysis in the two subgroups were the same as the study including 18 trials [Figure 4].
Figure 4: Forest plot of odds ratio (OR) for evaluation of objective tumor response

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The KPS improvement

Eighteen studies showed little significant heterogeneity on the KPS improvement (χ2 = 7.25, P = 0.98, I 2 = 0%). The results for statistical analysis according to the fixed-effects model demonstrated that the combined treatment group can improve the KPS more (n = 1,523, OR = 3.37, 95% CI: 2.71-4.20, Z = 10.86, P < 0.00001) [Figure 5].
Figure 5: Forest plot of OR for evaluation of the Karnofsky performance scale improvement

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The reaction of digestive tract

Twelve studies [14],[15],[16],[17],[19],[20],[21],[23],[24],[26],[28],[29] reported the chemotherapy-induced adverse reaction of digestive tract on nausea and vomiting. We applied the fixed-effects model because of little heterogeneity (χ2 = 6.76, P = 0.82, I 2 = 0%). And the pooled results exhibited that Kang`ai injection could decrease the risk of chemotherapy-induced nausea and vomiting (n = 1,027, OR = 0.42, 95% CI: 0.32-0.55, Z = 6.34, P < 0.00001) [Figure 6].
Figure 6: Forest plot of OR for evaluation of the reaction of digestive tract

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The bone marrow suppression

Fourteen studies [14],[15],[16],[17],[19],[20],[21],[22],[23],[24],[26],[27],[28],[29] provided the data of the bone marrow suppression. There was little heterogeneity by the heterogeneity test among the studies (χ2 = 6.76, P = 0.82, I 2 = 0%). Thus, the fixed-effects model should be used for statistical analysis. The pooled results indicated that Kang`ai injection had certain protective efficacy on the function of the bone marrow (n = 1,146, OR = 0.38, 95% CI: 0.29-0.49, Z = 7.37, P < 0.00001) [Figure 7].
Figure 7: Forest plot of OR for evaluation of the bone marrow suppression

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Publication bias

Funnel plots based on the data of the each effect size are shown in [Figure 8]. All the four parts in the Figure were asymmetrical, which indicated that publication bias might influence the results of the analysis. Although we carried out comprehensive searching and tried to avoid bias, we could not exclude potential publication bias because of all the included trials published in Chinese; (a) funnel plot of objective tumor response, (b) funnel plot of the KPS, (c) funnel plot of the reaction of digestive tract, and (d) funnel plot of the bone marrow suppression.
Figure 8: Funnel plot for evaluation of the publication bias (a) Funnel plot of objective tumor response, (b) Funnel plot of the Karnofsky performance scale, (c) Funnel plot of the reaction of digestive tract, (d) Funnel plot of the bone marrow suppression

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 > Discussion Top


At present, systematic reviews or meta-analysis is the highest-level of evidence in the evidence-based medicine. Meta-analysis can permit the user to perform statistical synthesis and can be used to enhance the statistical power and get a more credible conclusion. Thus, in order to demonstrate whether Kang`ai injection can increase the efficacy, improve the quality of life, and decrease the toxicity when combined with systematic chemotherapy for advanced NSCLC; we carried out this meta-analysis. The results suggested that Kang`ai injection could increase the objective response rate (OR = 1.51, 95% CI: 1.23-1.85, Z = 3.94, P < 0.0001), improve the quality of life (OR = 3.37, 95% CI: 2.71-4.20, Z = 10.86, P < 0.00001), decrease the adverse reaction of digestive tract (OR = 0.42, 95% CI: 0.32-0.55, Z = 6.34, P < 0.00001), and prevent bone marrow suppression (OR = 0.38, 95% CI: 0.29-0.49, Z = 7.37, P < 0.00001). This study might confirm that Kang`ai injection combined with chemotherapy could increase short-term efficacy, improve quality of life, and reduce chemotherapy toxicity. Meanwhile, it could also provide supplementing evidence for TCM combined with chemotherapy in the treatment of advanced NSCLC.

Kang`ai injection consists of extraction of Astragalus membranaceus (huangqi) and ginseng (renshen), combined with oxymatrine. Astragalus membranaceus and ginseng are Chinese medicinal herbs, which are used to tonify Qi for improving the symptoms of Qi deficiency in TCM. In modern medicine, the two herbs have been confirmed that they both have the immunomodulation function and are usually used to alleviate the adverse effects of chemotherapy through their pharmacological activity researches. [30],[31],[32] Oxymatrine is an effective ingredient of Sophora flavescens. The research demonstrated that oxymatrine can increase the sensitivity of chemotherapy to kill tumor cells effectively. [33] Kang`ai injection is developed from Astragalus membranaceus, ginseng, and Sophora flavescens; which suggests that the injection's effect in the treatment of NSCLC may be related to their mutual pharmacological activities. However, there still exist many questions unclear about Kang`ai injection, such as specific immunological mechanisms, the interactions among them, the main effective targets, etc., Thus, we should require further researches for answering these questions.

This meta-analysis has the following limitations. First, all included trials were published in Chinese and funnel plot was asymmetrical, due to which publication bias might exist. Second, only one author of the papers was contacted, and then the trial details were obtained. We tried to contact the other authors to get further information, but failed. So the other trials' quality evaluations were only according to the papers. We found that both allocation concealment and blinding were not described in these trials, and there were 15 trials not mentioning the methods of sequence generation, which might result in the emergence of bias and overestimation of efficacy. Third, the study periods were generally short, and none of the included trials made a long-term follow-up. Since NSCLC has been seen as a chronic condition, it should be a great concern of patients about the effect of long-term treatment. Thus, designing RCTs of Kang`ai injection to measure the follow-up is necessary. Because of above reasons, the evidence from this study might be insufficient, so the medicine should be carefully evaluated and disseminated. However, although there might exist above questions which prevented us from drawing a definite conclusion for Kang`ai injection, it still provided helpful information for clinical practice that Kang`ai injection can enhance the efficacy and reduce the chemotherapy-induced toxicity. In order to make better development of TCM and get more convincing evidence, more well-designed clinical trials are needed.


 > Conclusion Top


In conclusion, this meta-analysis indicated that Kang`ai injection could increase the efficacy, improve the quality of life, and reduce the chemotherapy toxicity, when combined with systematic chemotherapy for advanced NSCLC. But considering the limitations, the conclusion should be interpreted carefully.

 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
 
 
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