|Year : 2014 | Volume
| Issue : 5 | Page : 52-55
Aidi injection combined with FOLFOX4 chemotherapy regimen in the treatment of advanced colorectal carcinoma
Tao Wang1, Huilan Nan2, Chunze Zhang3, Yan Wang4, Xipeng Zhang3, Yuwei Li3, Mulati5
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 Publication||30-Aug-2014|
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
Source of Support: None, Conflict of Interest: None
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|| |
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.  In China, the colorectal cancer incidence was rapidly increased since 1980 and ranked as the fifth leading cause of cancer-related death.  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.  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. 
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. 
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|| |
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.
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),  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].
Chemotherapy related toxicity evaluation
The chemotherapy related toxicity were assessed and graded according to WHO criteria. 
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|| |
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].
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].
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).
| > Discussion|| |
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. , For early stage non-metastatic colorectal cancer, the standard surgical procedure was colectomy with en bloc removal of the regional lymph nodes.  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.  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. 
Currently, the FOLFOX4 regimen is commonly administered for advanced colorectal cancer as an effective regimen. , However, how to increase efficacy and decrease toxicity of FOLFOX4 remains a focus in this area. 
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. , 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. 
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.
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[Table 1], [Table 2], [Table 3]