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ORIGINAL ARTICLE
Year : 2014  |  Volume : 10  |  Issue : 5  |  Page : 52-55

Aidi injection combined with FOLFOX4 chemotherapy regimen in the treatment of advanced colorectal carcinoma


1 Department of Colorectal Surgery, Tianjin Union Medicine Center; Tianjin University of Traditional Chinese Medicine, Tianjin, China
2 Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin Geriatrics Institute, Tianjin, China
3 Department of Colorectal Surgery, Tianjin Union Medicine Center, Tianjin, China
4 Department of Colorectal Surgery, Anorectal Hospital Affiliated to Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
5 Department of Gastrointestinal Thyroid Surgery, the First Affiliated Hospital of Shihezi University, Shihezi, Xinjiang Uygur Autonomous Region, China

Date of Web Publication30-Aug-2014

Correspondence Address:
Mulati
Department of Gastrointestinal Thyroid Surgery, the First Affiliated Hospital of Shihezi University, Shihezi, 832000 China. Shibei 2 Road, Shihezi City, Xinjiang Uygur Autonomous Region, Shihezi, P.R.C 832000
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.139760

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 > Abstract 

Objective: The aim of this retrospectively study was to evaluate the clinical efficacy of Aidi injection (ADI) combined with FOLFOX4 chemothreapy regimen in the treatment of advanced colorectal carcinoma.
Patients and Methods: One hundred and twenty one patients with pathology confirmed advanced colorectal carcinoma were retrospectively analyzed in the department of colorectal surgery in Union Medical Center, Tianjin (UMC). Of the included 121 cases, 58 subjects received the treatment of ADI combined with FOLFOX4 chemotherapy (experiment group) and the other 63 cases received the FOLFOX4 chemotherapy alone (control group). After two cycles chemotherapy treatment, the short-term clinical efficacy such as complete response (CR), partial response (PR) and objective response rate (ORR) were compared between the two groups. The quality of life improvement and chemotherapy related toxicity were also recorded and analyzed.
Results: The response rate including CR, PR and ORR were not statistical different between the experiment group and control group (P > 0.05); The KPS score was significant decrease in the control group compared to that in experiment group (P < 0.05); The risk of developing grade-II nausea vomiting and diarrhea was much lower in experiment than that in control group (Pall < 0.05).
Conclusion: ADI combined with FOLFOX4 chemotherapy can improve the quality of life and decrease some of the toxicity related to chemotherapy in patients with advanced colorectal cancer.

Keywords: Advanced colorectal cancer, aidi injection, clinical efficacy


How to cite this article:
Wang T, Nan H, Zhang C, Wang Y, Zhang X, Li Y, Mulati. Aidi injection combined with FOLFOX4 chemotherapy regimen in the treatment of advanced colorectal carcinoma. J Can Res Ther 2014;10, Suppl S1:52-5

How to cite this URL:
Wang T, Nan H, Zhang C, Wang Y, Zhang X, Li Y, Mulati. Aidi injection combined with FOLFOX4 chemotherapy regimen in the treatment of advanced colorectal carcinoma. J Can Res Ther [serial online] 2014 [cited 2020 Feb 29];10:52-5. Available from: http://www.cancerjournal.net/text.asp?2014/10/5/52/139760

Tao Wang, Huilan Nan and Chunze Zhang contribute equally to this work



 > Introduction Top


Colorectal cancer is the third most commonly diagnosed cancer in males and the second in females, with over 1.2 million new cancer cases and 608,700 deaths estimated to have occurred in 2008. [1] In China, the colorectal cancer incidence was rapidly increased since 1980 and ranked as the fifth leading cause of cancer-related death. [2] Thus, colorectal cancer has become one of the most common solid tumors in China which seriously hazard to public health. For patients with early stage of this disease, the surgery procedure was always used with acceptable 5 year survival. But for patients with advanced stage or metastasis lesions the operation was generally not suitable. Accord to the National Comprehensive Cancer Network (NCCN) clinical practice guideline in colon cancer, patients with advanced state can benefit from the systematic chemotherapy compared to best supportive care. And the most common use chemotherapy regimen were FOLFOX4, FOLFIR, CapeOx and etc. [3] With systematic chemotherapy or chemoradiation the life expectancy could be prolonged in patients with advanced colorectal cancer. But the chemotherapy drug usually damage the immune system and decrease the patients quality of life in period of chemotherapy. [3]

Aidi injection (ADI), made by extraction from Renshen (Ginseng Radix et Rhizoma), Huangqi (Astragali Rdix), Ciwujia (Acanthopanacis Senticosi Radix et Rhizoma seu Caulis), and Banmao (Mylabris), is used for the clinical treatment of several types of carcinomas including non-small cell lung cancer, gastric cancer, colorectal cancer and etc. [4]

In this study, we retrospectively analyzed 58 and 63 subjects treated with FOLFOX4 + ADI and FOLFOX4 chemotherapy alone respectively to evaluate the clinical efficacy of ADI in the treatment of advanced colorectal carcinoma.


 > PATIENTS and METHOD Top


Patients

One hundred and twenty one patients with pathology confirmed advanced colorectal carcinoma were retrospectively analyzed in the department of colorectal surgery in Union Medical Center, Tianjin (UMC). Of the included 121 cases, 58 subjects received the treatment of ADI combined with FOLFOX4 chemotherapy (experiment group) and the other 63 cases received the FOLFOX4 chemotherapy alone (control group). The inclusion criteria were: (1) Patients more than 18-years-old; (2) Pathologically confirmed colorectal carcinoma; (3) With at least one appreciable lesion; (4) Received FOLFOX4 or FOLFOX4 + ADI; (5) With completely clinical data of response rate, quality assessment and chemotherapy related toxicity.

Methods

In this study, 63 cases received the FOLFOX4 chemotherapy regimen. The detailed chemotherapy drug was administrated as intravenous (iv) leucovorin calcium at a dose of 200 mg/m 2 , iv bolus Fluorouracil (5-FU) at a dose of 400 mg/m 2 and continuous iv 5-FU at a dose of 600 mg/m 2 on day 1, day 2, Oxaliplatin 85 mg/m 2 repeated every 2 weeks. ADI delivery as 60-80 ml intravenous infusion on iv, once daily, for 7 days when giving FOLFOX4 chemotherapy regimen.

Short-term efficacy evaluation

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.

Quality of life assessment

Quality of life was evaluated in accordance with the Karnofsky Scale (KPS). The KPS runs from 100-0, where 100 is "perfect" health and 0 is death. The detail score evaluation system was demonstrated in [Table 1].
Table 1: The Karnofsky scoring system


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Chemotherapy related toxicity evaluation

The chemotherapy related toxicity were assessed and graded according to WHO criteria. [6]

Statistical analysis

STATA11.0 software was used to do the statistical analysis. Measurement data was expressed as mean values ± standard deviation (SD). Data were evaluated by student t-test; The dichotomous data was expressed as percentage (%) and evaluated by Chi-square. The two side P < 0.05 was considered statistical difference.


 > Results Top


The ORR was 34.5% (20/58) and 33.3% (21/63) in the experiment group and control group respectively. The results demonstrated there was no statistical difference of ORR between the two groups (P > 0.05) [Table 2].
Table 2: The short-term efficacy between the two groups (n, (%))


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The KPS score was 78.5 ± 12.5 and 80.1 ± 15.2 in the experiment and control groups prior treatment respectively. And after treatment three cycles treatment, the KPS score was 77.6 ± 14.2 and 70.2 ± 15.6. Significant decrease of KPS score was found in the control group to that in experiment group (P < 0.05) [Figure 1].
Figure 1: The KPS score between the two groups prior and post treatment

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The chemotherapy related toxicity was showed in [Table 3]. The risk of developing grade-II nausea, vomiting and diarrhea in FOLFOX4 group was much higher than that in FOLFOX4 + ADi with significant statistics (P < 0.05).
Table 3: Chemotherapy related toxicity between the two groups (n, (%))


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 > Discussion Top


Colorectal cancer is the fourth most frequently diagnosed cancer and the second leading cause of cancer related death in the USA. In China, colorectal cancer incidence was rapidly increased since 1980 and ranked as the fifth leading cause of cancer-related death. [2],[7] For early stage non-metastatic colorectal cancer, the standard surgical procedure was colectomy with en bloc removal of the regional lymph nodes. [8] And for patients with advanced stage or metastatic colorectal carcinoma, the systematic chemotherapy was preferred and recommended which could prolong the life expectancy of patients compared to best supportive care. [9] Although the systematic chemotherapy can prolong the life expectancy, the treatment also damaged the immune system and cause severe side effects, which could compromise the quality of patients' life and sometimes interrupt the planned course of treatment. [10]

Currently, the FOLFOX4 regimen is commonly administered for advanced colorectal cancer as an effective regimen. [11],[12] However, how to increase efficacy and decrease toxicity of FOLFOX4 remains a focus in this area. [13]

ADI has been developed and manufactured by Guizhou Ebay Pharmaceutical Co., Ltd in China. Its functional components include Ban Mao (Mylabri), Ci Wu Jia (Radix Acantropanacis Senticosi), Huang Qi (Radix Astragali) and Ren Shen (Radix Ginsheng). ADI is one of the Chinese herbal preparation with anticancer activity, which used for the treatment of several tumors including colorectal cancer. [14],[15] Several experiments demonstrated that ADI has the antitumor function with the mechanism of inducing apoptosis, decreasing chemotherapy related toxicity and improving the immune system of patients. [16]

In this retrospective study, we included 121 patients with advanced colorectal cancer who received FOLFOX4 chemotherapy regimen or FOLFOX4 plus ADI therapy. After three cycles of treatment, the response rate including CR, PR and ORR were not statistical different between the experiment group and control group (P > 0.05); The KPS score was significant decrease in the control group compared to that in experiment group (P < 0.05); The risk of developing grade-Ͳς nausea, vomiting and diarrhea was much lower in experiment than that in control group (Pall < 0.05). The results indicated that ADi combined with FOLFOX4 chemotherapy can improve the quality of life and decrease some of the toxicity related to chemotherapy in patients with advanced colorectal cancer. Although the clinical efficacy of ADI in the assistant treatment of colorectal cancer has been confirmed in this study, the retrospective experiment design and limited number of patients included with a single medical center made the conclusion a limitation.

 
 > 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.Deng SX, Gao J, An W, Yin J, Cai QC, Yang H, et al. Colorectal cancer screening behavior and willingness: An outpatient survey in China. World J Gastroenterol 2011;17:3133-9.  Back to cited text no. 2
    
3.National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon cancer, V.3.2013. Available from: https://www.nccn.org/store/login/login.aspx?ReturnURL=http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf [Last accessed on 2014 Jun 20].  Back to cited text no. 3
    
4.Zhang MM, Liu YL, Chen ZG, Li XR, Xu QM, Yang SL. A new triterpenoid saponin from aidi injection. Chinese Herbal Medicines 2014;4:84-6.  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.Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-14.  Back to cited text no. 6
[PUBMED]    
7.Chen HM, Weng YR, Jiang B, Sheng JQ, Zheng P, Yu CG, et al. Epidemiological study of colorectal adenoma and cancer in symptomatic patients in China between 1990 and 2009. J Dig Dis 2011;12:371-8.  Back to cited text no. 7
    
8.Shin A, Jung KW, Won YJ. Colorectal cancer mortality in Hong Kong of China, Japan, South Korea, and Singapore. World J Gastroenterol 2013;19:979-83.  Back to cited text no. 8
    
9.Popov I, Jelic S, Krivokapic Z, Micev M, Babic D, Zdrale Z. What is the best sequence of chemotherapy in advanced colorectal cancer? Final results of a five-arm study. Chemotherapy 2006;52:20-2.  Back to cited text no. 9
    
10.Cecchin E, D'Andrea M, Lonardi S, Zanusso C, Pella N, Errante D, et al. A prospective validation pharmacogenomic study in the adjuvant setting of colorectal cancer patients treated with the 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX4) regimen. Pharmacogenomics J 2013;13:403-9.  Back to cited text no. 10
    
11.Masi G, Cupini S, Marcucci L, Cerri E, Loupakis F, Allegrini G, et al. Treatment with 5-fluorouracil/folinic acid, oxaliplatin, and irinotecan enables surgical resection of metastases in patients with initially unresectable metastatic colorectal cancer. Ann Surg Oncol 2006;13:58-65.  Back to cited text no. 11
    
12.Souglakos J, Androulakis N, Syrigos K, Polyzos A, Ziras N, Athanasiadis A, et al. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): A multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer 2006;94:798-805.  Back to cited text no. 12
    
13.Sugihara K, Ohtsu A, Shimada Y, Mizunuma N, Gomi K, Lee PH, et al. Analysis of neurosensory adverse events induced by FOLFOX4 treatment in colorectal cancer patients: A comparison between two Asian studies and four Western studies. Cancer Med 2012;1:198-206.  Back to cited text no. 13
    
14.Lou HZ, Pan HM, Jin W. Clinical study on treatment of primary liver cancer by Aidi injection combined with cool-tip radiofrequency ablation. Zhongguo Zhong Xi Yi Jie He Za Zhi 2007;27:393-5.  Back to cited text no. 14
    
15.Wang D, Chen Y, Ren J, Cai Y, Liu M, Zhan Q. A randomized clinical study on efficacy of Aidi injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer. Zhongguo Fei Ai Za Zhi 2004;7:247-9.  Back to cited text no. 15
    
16.Xu XT, Song Y, Qin S, Wang LL, Zhou JY. Radio-sensitization of SHG44 glioma cells by Aidi injection in vitro. Mol Med Rep 2012;5:1415-8.  Back to cited text no. 16
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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