|Year : 2014 | Volume
| Issue : 5 | Page : 79-81
Treatment of mid-late stage NSCLC using sodium cantharidinate/vitamin B6/GP regimen in clinic
Baoli Wang, Jiandong Cui
Department of Oncology, 303rd Hospital of People's Liberation Army, Nanning, Guangxi, China
|Date of Web Publication||30-Aug-2014|
Department of Oncology, 303rd Hospital of People's Liberation Army, Nanning, Guangxi, 530021
Source of Support: None, Conflict of Interest: None
Objective: The present study observed the clinical outcomes of the sodium cantharidinate/vitamin B6/GP regimen in the treatment of middle-late stage Non-small-cell lung carcinoma (NSCLC).
Materials and Methods: Eighty-six cases of NSCLC were selected and randomized into two groups. Forty-five cases in the treatment group were subject to 30 ml cantharidinate/vitamin B6+ GP regimen, for four 21-day cycles. Forty-one cases in the control group were subject to regular GP regimen, for four 21-day cycles.
Results: The effectiveness rate was 57.8% in the treatment group and 36.6% in the control group, suggesting statistical difference (P < 0.05); life quality in the treatment group was significantly better than that in the control group (P < 0.05); the occurrence rate of the toxic/adverse effects were significantly lower in the treatment group compared with that in the control group (P < 0.05).
Conclusion: Sodium cantharidinate/vitamin B6/GP regimen had fair effectiveness and synergistically improved the clinical outcomes. It lowered the toxic/adverse effects and its application is worth further investigation and promotion.
Keywords: GP regimen, non-small-cell lung carcinoma, sodium cantharidinate/vitamin B6 injection
|How to cite this article:|
Wang B, Cui J. Treatment of mid-late stage NSCLC using sodium cantharidinate/vitamin B6/GP regimen in clinic. J Can Res Ther 2014;10, Suppl S1:79-81
| > Introduction|| |
Lung cancer is one of the malignant tumors with high incidence rate in China, and also a primary reason for cancer death worldwide. Non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancers.  The ineffectiveness of lung cancer treatment is mainly attributed to the advance stage at diagnosis.  Therefore, chemotherapy plays important role in NSCLC treatment. In order to improve the efficacy of NSCLC chemotherapy of middle-late stage of NSCLC and lower the corresponding side effects, the present study applied sodium cantharidinate plus vitamin B6 to the GP protocol (treatment group) and results were compared with the regular GP protocol (control group). The data were reported below.
| > Materials and methods|| |
Case inclusion criteria
The selected cases all underwent computed tomography guided (CT-guided) needle biopsy or bronchoscopy biopsy combined with the pathological diagnosis. Stage III b or stage IV NSCLC patients all had measurable lesions, had not received chemo-/radio-therapy for nearly a month, did not have heart/lung/liver/kidney disorders, and had an expected survival of over 3 months.
Patients with middle-late stage NSCLC were randomized into two groups (lottery method). Treatment group: 23 cases of squamous cell carcinoma, 21 cases of adenocarcinoma, one case of adenosquamous carcinoma; 26 cases with stage III b , 19 cases with stage IV (30 first-time treatment cases, 15 re-treatment cases). Control group: 15 cases of squamous cell carcinoma, 23 cases of adenocarcinoma, three cases of adenosquamous carcinoma; 22 cases with stage III b , 19 cases with stage IV (31 first-time treatment cases, 10 re-treatment cases). PS scores in both groups ranged: 0-2.
Treatment groups were subject to the GP regimen with sodium cantharidinate plus vitamin B6: 30 ml sodium cantharidinate/vitamin B6 injection (Aiyisu, Guizhou Baiqiang Pharmaceutical Company Limited) was prepared with 500 ml 0.9% saline and administered through intravenous (IV) route once daily for continuous 14 days. Gemcitabine chloride (Jiangsu Haoshen Pharmaceutical Company), at a dose of 1000 mg/m 2 , was administered IV on day 1 and day 8, and cisplatin, at a dose of 75 mg/m 2 , was administered on day 1, followed by forced diuresis on the same day. A complete cycle is consisting of 21 days. The control group was subject to GP regimen without sodium cantharidinate plus vitamin B6 and followed the same protocol as above.
Observation items and evaluation criteria
Evaluation of the treatment outcomes
Tthe evaluation followed the World Health Organization (WHO) guidelines for solid tumor responses, CR - complete response, PR - partial response, NC - no change, and PD - progressive disease. The effectiveness rate was evaluated based on CR + PR. Adverse effects: On the basis of WHO standards for anticancer drug acute/subacute toxicity, a 0-4 grading system was used. Life quality: KPS grading system was followed and changes in body weights were recorded; if KPS score was 10 points higher after the treatment, the life quality was considered to be improved; if KPS score was 10 points lower after the treatment, the life quality was considered to be worsened; if the score change was between −/+10 points, the life quality was considered to be stable. An increase of 1 Kg in body weight was considered to be increased body weight, a decrease of 1 Kg in body weight was considered to be decreased body weight, and changes within 1 Kg was considered to be stable body weight.
Statistical method SPSS 13.0 software was used to process the data. Quantitative data was analyzed using t test, and counts data was analyzed using X2 test. P < 0.05 was considered to be statistically significant.
| > Results|| |
Comparison of short-term treatment outcomes between the two groups, both groups completed the test and no CR cases were observed. The effectiveness rate was 57.8% in the treatment group and 36.6% in the control group, indicating significant difference between the two groups (P < 0.05) [Table 1].
|Table 1: Evaluation of the treatment outcomes in treatment/ control group (# of cases, %) |
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Comparison of the life quality between the two groups On the basis of KPS grading standards, in the treatment group, 30 cases had improved life quality, and eight cases has worsened life quality; in the control group, 17 cases had improved life quality, and 15 cases has worsened life quality. The degree of life quality improvement displayed significant difference (P < 0.05), as shown in [Table 2].
|Table 2: Comparison of KPS between the treatment group and control group |
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Toxic/adverse effects In both groups, the toxic/adverse effects were myelosuppresion, damaged liver/kidney function, nausea, vomiting, cardiac toxicity, and phlebitis. The general occurrence rates of the myelosuppression in both groups were similar; however, the occurrence rate of the myelosuppression in stage III ~ IV patients of the treatment group was significantly lower than that in the control group. The former was 22.2% and the latter was 43.9% (P < 0.05). The occurrence rates of other toxic/adverse effects did not present significant differences (P > 0.05), as shown in [Table 3].
|Table 3: Toxic/adverse effects in the treatment group and the control group |
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| > Discussion|| |
Currently, outcomes of the middle-late stage NSCLS chemotherapy are better than that of the best support care (BSC). Platinum-based chemotherapy is effective in NSCLC treatment and has become the routine option for NSCLC treatment. However, the side effects resulting from the chemotherapy are intolerable for many patients, leading to the discontinuation of the treatment.  Seeking a drug that can improve the treatment outcomes, promote the host immunity, and lower the toxic/adverse effects of the chemotherapy is one of the directions in the current tumor treatment research. Traditional Chinese medicine (TCM) is unique in improving host immunity and lowering the toxic/adverse effects.  The major ingredient in sodium cantharidinate/vitamin B6 injection is sodium cantharidinate, which is derived from cantharidin. Sodium cantharidinate preserves the unique anticancer activity of cantharidin and has lower toxic/adverse effects. Its combination with the vitamin B6 can further lower the side effects of sodium cantharidinate. Sodium cantharidinate is the semi-synthetic derivative of cantharidin. It can inhibit the protein/nucleotide synthesis in tumor cells. Basic research shows that cantharidin can block the G/M phase entry from S phase in tumor cells, inhibit cell proliferation, and induce the apoptosis in the tumor cells. , Sodium cantharidinate also possesses the immunoregulatory function. It is capable of activating the natural killer cell (NK cell)/tumor-infiltrating lymphocytes (TIL), and stimulating the macrophage/lymphocytes to produce interleukin, so that the anticancer effects can be improved.  Studies in recent years showed that sodium cantharidinate/vitamin B6 injection can stimulate apoptosis in lung cancer cells A549, inhibit their proliferation, and therefore is an effective drug in lung cancer treatment. ,
In summary, the application of sodium cantharidinate/vitamin B6/GP regimen in the treatment of middle-late stage NSCLC can improve the rate of the disease control and slower the disease progression. It alleviates the side effects associated with the chemotherapy, improves life quality of the patients, and its application in clinic is worth promoting.
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[Table 1], [Table 2], [Table 3]