Rectal cancer is a clinically common malignant tumor disease [
The patients with rectal cancer who underwent neoadjuvant therapy in our hospital from February 2016 to February 2018 were selected as the study subjects and divided into the control group and experimental group according to the order of admission. There were no significant differences between the two groups in general clinical data such as age and pathological classification, with comparability (
General clinical data of the two groups of patients.
Factors | Control group ( | Experimental group ( | |||
---|---|---|---|---|---|
Gender | Male | 22 | 23 | 0.05 | 0.82 |
Female | 18 | 17 | |||
Average age | — | 55.32 ± 4.75 | 55.38 ± 4.26 | 0.06 | 0.95 |
Neoplasm staging | Stage II | 26 | 25 | 0.05 | 0.82 |
Stage III | 14 | 15 | |||
Pathological classification | Mucinous carcinoma | 3 | 4 | 0.16 | 0.69 |
Adenocarcinoma | 37 | 36 | |||
Differentiation | Poorly differentiated | 11 | 12 | 0.22 | 0.90 |
Moderately differentiated | 15 | 13 | |||
Well differentiated | 14 | 15 |
Patients who met the WHO diagnostic criteria for rectal cancer were clinically diagnosed as rectal cancer in our hospital and received neoadjuvant therapy
Patients were or elder than 18 years old
This study has been approved by the hospital ethics committee (no. 20160145)
Patients and their family were informed of the whole process of treatment and signed the informed consent
Patients had major organ diseases such as kidney, liver, and heart diseases
Patients had mental, cognitive, and behavioral disorders
Patients had the history of drug allergy
Patients had inflammatory bowel disease and hereditary colorectal cancer
All patients were treated with radiation therapy after neoadjuvant therapy. The radiation instrument Varian Clinac CX 10MV medical electronic linear accelerator was adopted in this study. After simulated positioning, CT enhanced scanning was performed, with the slice thickness of 5 mm. In the emphasized planning system, coplanar multifield conformal irradiation was performed, with the total dose of 60 Gy∼66 Gy (2 Gy/d, 1 time/d, 5 times/week). On the basis of that, the experimental group was treated with Xeloda capecitabine tablets (State Food and Drug Administration approval number: H20073024; manufacturer: Shanghai Roche Pharmaceutical Co., Ltd.), with a total daily dose of 2500 mg (1250 mg/time, once 30 minutes after breakfast and dinner by oral administration). After 14 days of continuous administration, the drug was discontinued for 7 days and 2 courses of treatment were carried out in succession with each course lasting 21 days.
The therapeutic efficacy was analyzed according to the response evaluation criteria in solid tumors which were divided into complete remission, partial remission, stable disease, and disease progression. Complete remission refers to the disappearance of all tumor lesions for 28 days. Partial remission refers to the reduction of tumor lesion long diameter by more than 30% for 28 days. Stable disease refers to the increase of tumor lesion long diameter by less than or equal to 20% or the reduction by less than or equal to 30%. Disease progression refers to the increase of tumor lesion long diameter more than 20%. The effective rate of treatment = (complete remission + partial remission)/total number of cases × 100%.
The CEA (serum carcinoembryonic antigen) levels before and after treatment were analyzed and compared between the two groups.
Adverse reactions such as nausea, vomiting, hand-foot syndrome, diarrhea, myelosuppression, and mucocutaneous impairments were analyzed and compared between the two groups.
The recurrence rate in the two groups of patients was analyzed and compared.
Two-year follow-up was carried out for the two groups of patients, and the progression-free survival and 2-year survival rate in the two groups were analyzed.
The data software SPSS18.0 was adopted in this study to process and analyze the research data. Measurement data were expressed by
The effective rate of treatment in the experimental group was significantly higher than that in the control group, with statistical significance (
Therapeutic efficacy in the two groups of patients.
Group | Cases | Complete remission | Partial remission | Stable disease | Disease progression | Effective rate of treatment |
---|---|---|---|---|---|---|
Control group | 40 | 0 | 20 | 15 | 5 | 50% (20/40) |
Experimental group | 40 | 3 | 32 | 5 | 0 | 87.5% (35/40) |
— | — | — | — | — | 13.09 | |
— | — | — | — | — |
Before treatment, there were no significant differences in CEA levels between the experimental group of 9.53 ± 3.96 ng/ml and the control group of 9.49 ± 3.86 ng/ml (
CEA levels in two groups. Note: the abscissa from left to right indicates before treatment and after treatment, while the ordinate indicates the CEA level (unit: ng/ml). The CEA level in the experimental group is significantly lower than that in the control group after treatment.
The incidence of adverse reactions in the experimental group was significantly lower than that in the control group, with statistical significance (
Incidence of adverse reactions in the two groups of patients.
Group | Cases | Nausea/vomiting | Hand-foot syndrome | Diarrhea | Myelosuppression | Mucocutaneous impairments | Incidence of adverse reactions |
---|---|---|---|---|---|---|---|
Control group | 40 | 4 | 2 | 5 | 2 | 3 | 40% (16/40) |
Experimental group | 40 | 1 | 0 | 1 | 0 | 0 | 5% (2/40) |
— | — | — | — | — | — | 14.05 | |
— | — | — | — | — | — |
The recurrence rate of 10% (4/40) in the experimental group was significantly lower than 30% (12/40) in the control group, with statistical significance (
Groups of patients with recurrence rate. Note: the abscissa indicates the control group and experimental group, while the ordinate indicates number of relapses (unit: case). The number of relapses in the experimental group is significantly less than that in the control group.
After two-year follow-up, it was found that the progression-free survival of 21.53 ± 6.23 months in the experimental group was significantly longer than 18.18 ± 5.41 months in the control group, with statistical significance (
Progression-free survival of the two groups. Note: the abscissa from left to right indicates the control group and experimental group, while the ordinate indicates progression-free survival (unit: month). The progression free survival in the experimental group was significantly longer than that in the control group.
2-year survival rate of the two groups. Note: the abscissa from left to right indicates the control group and experimental group, while the ordinate indicates number of patients (unit: case). The 2-year survival rate in the experimental group was significantly higher than that in the control group.
Rectal cancer is a clinically common malignant tumor disease, which commonly affects rectum [
Capecitabine is a new 5-FU prodrug. After oral administration, patients convert fluoropyrimidine compounds into 5-FU under the action of thymidine phosphorylase (TP) in vivo. Due to the higher concentration of TP in tumor cells and the lower concentration of TP in normal cells, the activity of TP in tumor cells can be enhanced by radiotherapy, and the effect of 5-FU can be further improved. Therefore, radiotherapy combined with capecitabine in rectal cancer patients after neoadjuvant therapy has great advantages [
Neoadjuvant therapy might increase adverse reactions, decrease therapeutic tolerance, and increase the recurrence rate in rectal cancer patients. This study found that the recurrence rate and the incidence of adverse reactions in the experimental group were significantly lower than those in the control group, with statistical significance (
According to Velenik et al. [
In conclusion, radiotherapy combined with capecitabine in rectal cancer patients after neoadjuvant therapy can improve the clinical efficacy with fewer adverse reactions and longer patients’ survival, which is worthy of promotion and application after neoadjuvant therapy for rectal cancer.
The data used to support the findings of this study are available from the corresponding author upon request.
The authors declare that there are no conflicts of interest.