SUMMARY: In this study, 152 patients with malignant ovarian cancer were randomly divided into the treatment group (79 subjects) and control group (73 subjects) according to the random number table method. Diagnosis of malignant ovarian cancers was confirmed by postoperative pathological diagnosis, exfoliated cell examination and biopsy for all subjects. There was no significant difference in terms of age and types of cancer between the two groups; thus, the two groups were statistically comparable (P>0.05).
The control group was treated with the routine TC chemotherapy regimen, including taxol 175 mg·m-2 and intravenous carboplatin AUC6. Number of treatments was two, with a treatment interval of 3 weeks. In addition to the chemotherapy, subjects in the treatment group also received oral Shenyi capsules (參一膠囊, contains 10mg ginsenoside Rg3 per capsule), 2 capsules twice a day before meal for 8 weeks.
The following monitoring parameters were evaluated during the course of treatment in both groups: 12 tumor markers, CT scan examination, blood routine and liver function (including the lowest value of leukocyte and platelets, and the highest value of alanine aminotransferase/aspartate aminotransferase), adverse reactions caused by side effects of chemotherapy (nausea, vomiting, diarrhea, peripheral nerves symptoms, etc.), and change in quality of life score. Response Evaluation Criteria In Solid Tumours 1.1 (RECIST 1.1) was also applied, and the result was classified as:
- Complete Response (CR): The lesion has completely resolved and maintained for more than 4 weeks.
- Partial Response (PR): The lesion is reduced by more than 50%, maintained for more than 4 week with no new lesion.
- Stable Disease (SD): The lesion is reduced by less than 50% or increased by less than 25% with no new lesion.
- Progressive Disease (PD): The lesion has increased by more than 25%, or new lesions have appeared.
The side effects of chemotherapy were classified into level 0 to IV according to the NCI-TCT 3.0.
Table 1. Comparison of Total Effective Rate and Total Benefit Rate between Control Group and Treatment Group
N(%)
| Group | n | CR | PR | SD | PD | Total Effective Rate | Total Clinical Benefit Rate |
| Control | 73 | 3 (4.11) | 24 (32.88) | 25 (34.25) | 21 (28.77) | 27 (36.99) | 52 (71.23) |
| Treatment | 79 | 5 (6.33) | 36 (45.57) | 28 (35.44) | 10 (12.66) | 41 (51.90) | 69 (87.50)# |
While there was no significant difference in the total effective rate between the two groups (P > 0.05), the total clinical benefit rate of the treatment group was significantly higher than the control group (P <0.05). The improvement in the value of platelets, leukocytes, alanine aminotransferase/aspartate aminotransferase was more significant in the treatment group, and nausea and vomiting were milder in the treatment group comparing to the control group (P <0.05). There was no significant difference in diarrhea and peripheral nerve adverse reactions between the two groups (P > 0.05). The quality of life also showed a more significant improvement in the treatment group than the control group (P < 0.05). Therefore, it is suggested that Shenyi capsule combined with taxol and carboplatin chemotherapy may significantly improve effective rate, survival rate, and the quality of life in patients with malignant ovarian cancer.
Yi-Ling, Yang, et al. Journal of Changchun University of Chinese Medicine. 2021. 37 (5): 10591062.