Application of combination of radiotherapy and tegafur suppository in treatment of non-operative middle and advanced esophageal cancer of old people

Abstract

The invention relates to the technical field of medicine, and discloses application of radiotherapy and tegafur suppository in treatment of inoperative middle and advanced esophageal cancer of old people, the radiotherapy adopts a 6-10-MV linear accelerator for radiotherapy at 1.8 Gy / day, the tegafur suppository is inserted into the anus by 2 cm at 19: 00 and 1: 00 in the next day according to the use method of 0.5 g / qd or bid, and the tegafur suppository is inserted into the anus by 2 cm at 19: 00 and 1: 00 in the next day. The tegafur suppository is applied to elderly patients with age of more than or equal to 60 years old, pathologically diagnosed, inoperative esophageal cancer in a clinical stage of IIA-IVA, initial treatment, no operation in the past, ECOG score of 0-1 score, predicted lifetime of more than or equal to 3 months, measurable or evaluable target focus, no symptoms before esophageal perforation, no distant metastasis and normal main organ functions. According to the tegafur suppository disclosed by the invention, a scheme of combining external anti-cancer drugs with radiotherapy is provided for senile esophageal cancer patients who cannot eat and cannot be operated, and the effective usage, dosage and medication cycle of the tegafur suppository for the senile esophageal cancer patients are determined.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and specifically to a therapeutic application of radiotherapy combined with tegafur suppository in the treatment of inoperable elderly middle- and late-stage esophageal cancer. Background Art

[0002] Esophageal cancer (EC) is a common malignant tumor in my country, with the morbidity and mortality ranking sixth and fifth respectively. As my country enters an aging society, the number of elderly patients with esophageal cancer has also increased accordingly. Surgery is the preferred treatment for early esophageal cancer, but most elderly patients with esophageal cancer are in the middle and late stages when they seek medical treatment. Currently, domestic and international guidelines recommend that patients with locally advanced esophageal cancer who cannot undergo surgery should receive concurrent chemotherapy radiotherapy (CCRT), and those who cannot tolerate concurrent chemotherapy radiotherapy should receive radical radiotherapy. However, CCRT has obvious toxic reactions, and the general condition of the elderly is poor. Due to physiological factors such as age, they often have underlying diseases and poor tolerance, which may lead to treatment interruption due to treatment-related toxic and side effects. Most experiments on esophageal cancer are aimed at young patients, and there are few prospective trials to evaluate the risks and benefits of CCRT in the elderly population. Therefore, elderly patients need a safe, effective and tolerable treatment regimen.

[0003] Tegafur is a derivative of 5-FU. Its suppository is rapidly absorbed through the rectal mucosa, thereby maintaining a long-term effective blood concentration in the body to exert the effect of radiosensitization and killing tumor cells. It is not affected by dysphagia and vomiting, and is especially suitable for patients who cannot take it orally. To further study the status of tegafur suppositories in the treatment of locally advanced non-surgical esophageal squamous cell carcinoma, the application of radiotherapy combined with tegafur suppositories in the treatment of elderly patients with advanced esophageal cancer who cannot undergo surgery was proposed, and the efficacy and toxicity of radiotherapy combined with tegafur suppositories in elderly patients with esophageal cancer were evaluated. Summary of the invention

[0004] In view of the deficiencies of the prior art, the present invention provides a therapeutic application of radiotherapy combined with tegafur suppository in the treatment of inoperable elderly patients with middle- and late-stage esophageal cancer, aiming to evaluate the efficacy and toxicity of radiotherapy combined with tegafur suppository in elderly patients with esophageal cancer.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions: a treatment application of radiotherapy combined with tegafur suppository in inoperable elderly middle- and late-stage esophageal cancer, wherein the radiotherapy uses a 6-10-MV linear accelerator for radiotherapy at 1.8Gy / day, with a standard fraction of 1.8-2Gy, 5d / W, a total of 60-70Gy, and starting from the second week, all patients use a CT-based radiotherapy plan; the usage of the tegafur suppository is 0.5g / qd or bid, inserted into the anus 2cm at 19:00 and 1:00 the next day, respectively, d1-14, 21d a cycle.

[0006] Preferably, the tegafur suppository is used for elderly patients aged ≥60 years, with pathologically confirmed and clinically staged IIA-IVA inoperable esophageal cancer, who are newly treated and have never undergone surgery, have an ECOG score of 0-1, are expected to survive ≥3 months, have measurable or evaluable target lesions, have no pre-signs of esophageal perforation and no distant metastasis, and whose major organs function normally.

[0007] Preferably, the criteria for normal function of the major organs are: routine blood examination criteria must meet the requirements of no blood transfusion or blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction, HB≥100g / L, ANC≥1.5×109 / L, PLT≥100×109 / L; biochemical examinations must meet the requirements of TBIL<1.5′ULN, ALT and AST<2.0′ULN, serum Cr≤1.5′ULN or endogenous creatinine clearance>50ml / min; pulmonary function FEV1≥1.5L or>80% of the predicted value.

[0008] The present invention provides a therapeutic application of radiotherapy combined with tegafur suppository in the treatment of inoperable elderly middle- and late-stage esophageal cancer. It has the following beneficial effects:

[0009] 1. The present invention provides a scheme of combining topical anticancer drugs with radiotherapy for elderly esophageal cancer patients who are unable to eat and cannot undergo surgery.

[0010] 2. The present invention determines the effective usage, dosage and medication cycle of Tegafur suppository for elderly patients with esophageal cancer. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 This is a diagram showing the metabolic process of the Tegafur suppository of the present invention being converted into 5-FU in vivo;

[0012] Figure 2 The present invention is a flowchart of the clinical trial case screening. DETAILED DESCRIPTION

[0013] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0014] Example:

[0015] Refer to the attached Figure 1 , Pharmacological effects of Tegafur suppositories: 5-FU is the main drug for adjuvant chemotherapy of esophageal cancer. Tegafur suppositories are derivatives of fluorouracil. They have no anticancer activity themselves and need to be converted into 5-fluorouracil under the action of the liver microsomal cytochrome P450 metabolic enzyme system to play an anti-tumor role. 5-FU is an analog of uracil and is converted into three active metabolites in cells: monophosphate fluorodeoxyuracil, triphosphate fluorodeoxyuracil and triphosphate fluorouracil. 5-FdUMP can effectively inhibit thymidylate synthase, and ultimately interfere with and block DNA, RNA and protein synthesis. It mainly acts in the S phase and is an anti-pyrimidine cell cycle-specific drug. The mechanism of action and anti-tumor spectrum of Tegafur suppositories are similar to those of fluorouracil, but with lower toxicity, higher chemotherapy index, good absorption, higher blood drug concentration and longer duration. The chemotherapy index is twice that of fluorouracil, and the toxicity is only 1 / 4 to 1 / 7 of that of fluorouracil. No severe bone marrow suppression was observed in the chronic toxicity test, and the effect on immunity was mild. Suppositories can be administered rectally and absorbed in the rectum, thereby maintaining long-term effective blood drug concentrations in the body, thereby exerting the effects of radiosensitization and killing cancer cells. They are not affected by dysphagia, vomiting, etc. and are suitable for patients who cannot take the drug orally.

[0016] Pharmacokinetics of Tegafur Suppositories: After administration, it is evenly distributed in the liver, kidney, small intestine, spleen and brain, with the highest concentration in the liver and kidney. This product is metabolized by the liver and excreted mainly through urine and respiratory tract. Due to its high lipid solubility, it can pass through the blood-cerebrospinal fluid barrier, and its concentration in cerebrospinal fluid is higher than that of fluorouracil. Within 24 hours after administration, 23% is excreted in the urine in its original form, and 55% is excreted in the form of CO2 from lung respiration.

[0017] Please see attached Figure 2 The embodiment of the present invention provides a treatment application of radiotherapy combined with tegafur suppository in the treatment of inoperable elderly patients with advanced esophageal cancer. The radiotherapy uses a 6-10-MV linear accelerator to perform radiotherapy at 1.8 Gy / day, with a standard fraction of 1.8-2 Gy, 5 d / W, a total of 60-70 Gy, and starting from the second week, all patients use a CT-based radiotherapy plan; the usage of tegafur suppository is 0.5 g / qd or bid, inserted into the anus 2 cm at 19:00 and 1:00 the next day, respectively, d1-14, 21d a cycle.

[0018] Radiotherapy including CT simulation positioning:

[0019] Supine position, arms straightened at the sides or elbows alternately placed in front of the forehead. Patients with cervical and upper segments are recommended to be fixed with head and neck shoulder masks, and patients with middle and lower segments and esophageal gastric junction cancer are recommended to be fixed with body membranes. For lower esophageal or esophageal gastric junction cancer, 3D or 4D simulated CT positioning can be used to observe the actual movement deviation of the tumor and improve the accuracy of radiotherapy, as esophageal tumors are greatly affected by the movement of organs such as breathing and heart. Intravenous contrast enhanced scanning is performed with a layer thickness of 0.5 cm. Enhanced scanning is not required for patients who are allergic to contrast agents.

[0020] For patients with cancer of the lower esophagus and esophagogastric junction, or who need to irradiate the left stomach and abdominal lymph nodes, in order to reduce the difference in irradiation volume caused by the size of the stomach, they should fast for 3 to 4 hours before CT simulation positioning, and take 400 ml of semi-liquid food (such as thick porridge, yogurt, etc., fixed amount each time) before CT scanning and 15 minutes before each radiotherapy. Patients with upper and middle esophageal cancer do not need this step.

[0021] Radiotherapy target area:

[0022] 1. GTV and GTVnd

[0023] The primary esophageal tumor that can be seen through various examinations is the GTV, and the lymph nodes that have been confirmed to have metastasized or cannot be excluded to have metastases are the GTVnd.

[0024] 2. CTV

[0025] Cervical / upper segment: GTV is 3-5 cm higher or lower, or GTVnd is 0.5-1 cm higher or lower, with the highest (lowest) as the boundary, generally including 1 (lower cervical, bilateral supraclavicular), 2, 4, 7 lymph node drainage areas;

[0026] Middle segment: GTV is enlarged 3 cm above and below, or GTVnd is enlarged 0.5 to 1 cm above and below, with the highest (lowest) as the boundary, generally including 1 (lower neck, bilateral supraclavicular), 2, 4, 7, and part of 8 lymph node drainage areas;

[0027] Lower segment / SiewertⅠ / SiewertⅡ type: GTV is 3-5cm higher or lower, or GTVnd is 0.5-1cm higher or lower, with the highest (lowest) as the boundary. Generally, it needs to include 7, part of 8, cardia, left stomach, and celiac trunk lymphatic drainage areas;

[0028] The above-mentioned GTV is extended 3cm or 5cm above and below. When there are no enlarged lymph nodes beyond 3cm, it is extended 3cm. If there are metastatic lymph nodes or suspected metastatic lymph nodes within the range of 3 to 5cm, it can be extended 5cm. If there are lymph nodes beyond 5cm, involved field irradiation can be considered.

[0029] 3.PTV

[0030] It is formed on the basis of CTV with an extension of 5mm, and the longitudinal extension can be up to 8mm. For cervical or upper esophageal cancer fixed with a head, neck and shoulder mesh, the extension can be 0.3cm.

[0031] Tegafur suppository is used for elderly patients aged ≥ 60 years, with pathologically confirmed clinical stage IIA-IVA inoperable esophageal cancer, first-time treatment and no previous surgery, ECOG score 0-1, expected survival period ≥ 3 months, measurable or evaluable target lesions, no signs of esophageal perforation and distant metastasis, and normal major organ function.

[0032] The criteria for normal function of major organs are: routine blood examination standards must meet the requirements of no blood transfusion or blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction, HB≥100g / L, ANC≥1.5×109 / L, PLT≥100×109 / L; biochemical examinations must meet the requirements of TBIL<1.5′ULN, ALT and AST<2.0′ULN, serum Cr≤1.5′ULN or endogenous creatinine clearance>50ml / min; pulmonary function FEV1≥1.5L or>80% of the predicted value.

[0033] This example aims to observe and evaluate the effectiveness and safety of radiotherapy combined with tegafur suppository in the treatment of inoperable locally advanced elderly esophageal cancer patients, and specifically includes the following steps:

[0034] S1. Radiotherapy: Radiotherapy was performed using a 6-10-MV linear accelerator at 1.8 Gy / day, standard fractionation (1.8-2 Gy, 5 days / week, total 60-70 Gy), starting in the second week. All patients used CT-based radiotherapy planning.

[0035] S2. Chemotherapy: Tegafur suppository 0.5 g / qd or bid; inserted into the anus 2 cm at 19:00 and 1:00 the next day; d1-14, 21 days per cycle;

[0036] S3. Enrollment: Subjects voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up. The inclusion criteria are:

[0037] 1. Able to provide written informed consent, and understand and agree to follow the research requirements and assessment schedule;

[0038] 2. Age: ≥60 years old;

[0039] 3. Patients with inoperable esophageal cancer diagnosed by pathology and clinical stage IIA-IVA;

[0040] 4. Patients who are new to treatment and have not undergone surgery before;

[0041] 5. ECOG score: 0-1 points (Table 2-1);

[0042] 6. Expected survival period ≥ 3 months;

[0043] 7. All patients should have measurable or evaluable target lesions;

[0044] 8. No signs before esophageal perforation; no distant metastasis;

[0045] 9. The major organs function normally, that is, meet the following criteria:

[0046] (1) The blood routine examination standards must meet (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):

[0047] a.HB≥100g / L;

[0048] b. ANC ≥ 1.5 × 109 / L;

[0049] c.PLT≥100×109 / L;

[0050] (2) Biochemical examinations must meet the following standards:

[0051] a.TBIL<1.5′ULN;

[0052] b. ALT and AST < 2.0′ ULN;

[0053] c. Serum Cr ≤ 1.5′ ULN or endogenous creatinine clearance > 50 ml / min (Cockcroft-Gault formula);

[0054] (3) Pulmonary function: FEV1 ≥ 1.5 L or > 80% of predicted value;

[0055] S4. Effectiveness evaluation and analysis:

[0056] The effectiveness evaluation is conducted every two cycles (the time is calculated in calendar days and is not affected by drug discontinuation), and the evaluation time is within ±7 days of the end of the cycle (excluding statutory holidays). The evaluation requires MRI examination, which is conducted every two cycles, and PET-CT evaluation is conducted once a year. The imaging detection technology used for the evaluation before and after the same patient should be the same, and all imaging data should be retained. Subjects with CR, PR and SD efficacy need to be re-examined 4 weeks after the first evaluation.

[0057] The best overall efficacy evaluation is the best efficacy record from the beginning to the end of the trial, and any necessary conditions should be taken into account for confirmation. Sometimes the efficacy response occurs after the end of treatment, so the protocol should clearly state whether the efficacy evaluation after the end of treatment is considered in the best overall efficacy evaluation. The protocol must clarify how any new treatment before progression affects the best efficacy response. The patient's best efficacy response mainly depends on the results of target lesions and non-target lesions and the manifestation of new lesions. In addition, it also depends on the nature of the trial, protocol requirements and outcome measurement criteria. Specifically, in non-randomized trials, the efficacy response is the primary goal, and the efficacy confirmation of PR or CR is necessary to confirm which is the best overall efficacy response. If PD confirmed by imaging occurs, the subject will terminate the trial and enter the follow-up period immediately. Before PD occurs, no other anti-tumor treatment can be performed. For patients who are discharged from the group due to intolerable toxic reactions, if no efficacy evaluation has been performed within 4 weeks before discharge, an efficacy evaluation should be performed at the time of discharge, and then imaging examinations should be performed at the same frequency, that is, every two cycles until disease progression or other anti-tumor treatment is used. Imaging evidence of PD in such patients must be obtained.

[0058] S5. Statistics: All statistical analyses were performed using IBM SPSS 26.0 software. Chi-square test or Fisher's exact test was used to compare the differences between the two groups of count data. T-test or U-test was used to compare the differences between the groups of measurement data according to whether the patient's age and tumor length conformed to the normal distribution. The univariate analysis method was used to analyze the factors affecting the short-term efficacy, and the potentially significant factors (univariate analysis P < 0.2) were screened for multivariate logistic regression analysis. P < 0.05 was considered to be statistically significant. All tests of the results of this trial were bilaterally tested, P ≤ 0.05 was considered to be statistically significant for the difference tested, and the confidence interval used a 95% confidence level.

[0059] This example screened 74 elderly patients with esophageal cancer, of which 7 did not meet the inclusion criteria and 5 refused to participate. The enrolled patients were randomly assigned to the synchronous chemoradiotherapy group (n = 32 cases) and the radiotherapy alone group (n = 30 cases). The intended treatment population was 62 cases. Two patients in the radiotherapy alone group did not complete radiotherapy. The baseline characteristics of the two groups of patients were well balanced. The median age of the synchronous chemoradiotherapy group was 77 years (range 65-86 years), including 25 males (78.1%) and 7 females (21.9%). 14 cases (43.8) had underlying diseases such as diabetes, hypertension, and coronary heart disease, and 1 case (3.1%) had a family history. Esophageal barium radioscopy before treatment showed that the median length of the esophagus was 5.46 cm. Only 1 case (3.1%) was adenocarcinoma. According to TNM staging, there were 11 cases (34.4%) of stage II patients and 21 cases (65.6%) of stage III or IVa. The median age of the radiotherapy alone group was 74 years (range, 63-83 years), with more male patients than female patients. Fifteen patients (50%) had underlying diseases. Before treatment, esophageal barium radioscopy showed that the median esophageal length was 4.29 cm. 29 patients (96.7%) were pathologically classified as squamous cell carcinoma, and most patients (63.3%) were in stage III clinical stage.

[0060] A total of 62 elderly patients with esophageal cancer were included. The treatment compliance is shown in Table 3-1. In the synchronous chemoradiotherapy group, 26 patients (81.3%) completed the radiotherapy combined with 2 cycles of tegafur suppository treatment as prescribed, and in the radiotherapy alone group, 27 patients (90%) completed the prescribed dose of radiotherapy. There was no statistically significant difference between the two groups (P = 0.475). The main reasons for not completing the prescribed treatment in the synchronous chemoradiotherapy group were: 1 patient (3.1%) developed grade 3 bone marrow suppression during the treatment period, 3 patients (9.4%) developed esophageal fistula, 1 patient (3.1%) developed grade 3 nausea and vomiting, and 3 patients (9.4%) developed radiation pneumonia during radiotherapy. The main reasons for not completing the prescribed radiotherapy in the radiotherapy alone group were: 1 patient (3.3%) developed grade 3 leukopenia, 1 patient (3.3%) developed esophageal fistula after 5 radiotherapy sessions, and 1 patient (3.3%) developed myocardial infarction after 6 radiotherapy sessions;

[0061]

[0062] Table 3-1 Treatment completion status of enrolled patients

[0063] Imaging examinations were performed regularly on 62 patients to evaluate the efficacy. As shown in Table 3-2, the synchronous chemoradiotherapy group achieved good short-term efficacy, with 1 patient (3.1%) achieving complete remission (CR), 17 patients (53.2%) achieving partial remission, 13 patients (40.6%) maintaining stable disease (SD), and only 1 patient (3.1%) experiencing disease progression (PD). The incidences of CR, PR, SD, and PD in the radiotherapy alone group were 0 (0), 8 (26.7%), 19 (63.3%), and 3 (10%), respectively. The objective remission rates of the synchronous chemoradiotherapy group and the radiotherapy alone group were statistically significant, at 56.3% and 26.7%, respectively (P=0.018). The disease control rates of the two groups were 96.9% and 90%, respectively.

[0064]

[0065] Table 3-2 Comparison of short-term efficacy between the chemoradiotherapy group and the radiotherapy alone group

[0066] A total of 13 factors, including patient gender, age, smoking history, drinking history, family history, underlying disease, lesion length, lesion type, tumor location, ECOG score, T stage, clinical stage, and concurrent chemotherapy, were used as independent variables for univariate analysis (Table 3-3), and variables with P < 0.2 were screened for multivariate Logistic regression analysis (Table 3-4). The results of univariate analysis showed that concurrent tegafur suppository chemotherapy was significantly correlated with the patient's short-term efficacy (P < 0.05). The results of multivariate analysis showed that the short-term efficacy was related to the treatment regimen, and patients who received radiotherapy and concurrent tegafur suppository chemotherapy had a better short-term efficacy.

[0067]

[0068]

[0069]

[0070] Table 3-3 Univariate analysis of factors affecting short-term efficacy

[0071]

[0072] Table 3-4 Multivariate logistic regression analysis of factors affecting the short-term efficacy of 62 elderly patients with esophageal cancer Comparison of T cell subset index levels before and after treatment in the two groups of patients:

[0073] There was no significant difference in the levels of CD3+, CD4+, CD8+, and CD4+ / CD8+ between the two groups before treatment (P>0.05). Compared with before treatment, the levels of CD3+(70.12±12.32)%, CD4+(37.08±2.43)%, CD8+(39.93±7.94)%, and CD4+ / CD8+(1.74±0.43)% in the synchronous chemoradiotherapy group were higher than those before treatment, while the levels of CD3+(76.10±9.73)% and CD8+(37.64±6.67)% in the radiotherapy group were higher than those before treatment, while CD4+(31.35±9.22)% and CD4+ / CD8+(1.28±0.92)% were lower than those before treatment. Compared with the radiotherapy alone group, the levels of CD3+, CD4+, CD8+, and CD4+ / CD8+ in the concurrent radiochemotherapy group were higher after treatment, but the differences were not statistically significant (P>0.05), see Tables 3-5.1 and 3-5.2.

[0074]

[0075] Table 3-5.1 / 3-5.2 Comparison of T cell subsets between the two groups of patients before and after treatment

[0076] Adverse reactions: Table 3-6 summarizes the early adverse reactions of treatment, which are mainly grade 0-2 adverse reactions. A total of 14 patients had grade ≥ 3 adverse events, including 9 cases in the concurrent chemoradiotherapy group and 5 cases in the radiotherapy alone group (28.1% vs 16.7%, P>0.05). In terms of hematological toxicity, 2 cases (6.3%) in the concurrent chemoradiotherapy group had grade 3 leukopenia, 1 case (3.1%) had grade 3 thrombocytopenia, 4 cases (12.5%) had grade 2 neutropenia, and no neutropenia of grade 3 or above occurred. In the radiotherapy alone group, 1 case (3.3%) had grade 3 leukopenia and 5 cases (16.7%) had neutropenia. Only 1 case in both groups had acute hematological toxicity of grade 3 or above, and the difference was not statistically significant (3.1% vs 3.3%, P>0.05). In terms of non-hematological toxicity, 5 patients (15.6%) in the synchronous chemoradiotherapy group developed grade 2 radiation esophagitis, 3 patients (9.4%) developed esophageal fistula during radiotherapy, and 3 patients (9.4%) developed grade 1 radiation pneumonitis. In the radiotherapy alone group, 1 patient (3.3%) developed grade 2 radiation esophagitis, 1 patient (3.3%) developed esophageal fistula, and no patient developed radiation pneumonitis. The incidence of grade 3 or above nausea and vomiting in the synchronous chemoradiotherapy group and the radiotherapy alone group was 3.3% and 0%, respectively (P>0.05); the incidence of grade 3 fever was 6.3% and 3.3% (P>0.05); the incidence of grade 2 constipation was 3.1% and 3.3%, respectively (P>0.05). There was no significant difference in the incidence of radiation esophagitis, radiation pneumonitis, esophageal fistula, nausea, vomiting, constipation, and fever between the two groups.

[0077]

[0078]

[0079] Table 3-6 Comparison of adverse reactions between the two groups of patients

[0080] In summary, a radiotherapy combined with tegafur suppository is used for the treatment of inoperable elderly middle- and late-stage esophageal cancer. Radiotherapy uses a linear accelerator with specific parameters and is based on CT planning. Tegafur suppositories are administered rectally at specific doses, times, and cycles. Elderly patients who meet specific conditions are enrolled and treated through a multi-step process, including radiotherapy, chemotherapy, inclusion criteria setting, effectiveness evaluation and analysis, and statistics. The results showed that the short-term efficacy of the synchronous radiochemotherapy group was better than that of the radiotherapy group alone, with a significant difference in objective remission rate, a good disease control rate, and no significant difference in adverse reactions between the two groups, providing a new application idea and solution for the treatment of elderly esophageal cancer.

[0081] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A method for treating inoperable elderly patients with advanced esophageal cancer by combining radiotherapy with tegafur suppository, characterized in that: The radiotherapy uses a 6-10-MV linear accelerator to perform radiotherapy at 1.8Gy / day, with a standard fractionation of 1.8-2Gy, 5d / W, a total of 60-70Gy, and starting from the second week, all patients use a CT-based radiotherapy plan; the usage of the tegafur suppository is 0.5g / qd or bid, inserted into the anus 2cm at 19:00 and 1:00 the next day, respectively, d1-14, 21d a cycle.

2. The use of radiotherapy combined with tegafur suppository in the treatment of inoperable elderly patients with advanced esophageal cancer according to claim 1, characterized in that: The Tegafur Suppository is used for elderly patients aged ≥ 60 years, with pathologically confirmed and clinically staged IIA-IVA inoperable esophageal cancer, who are newly treated and have not undergone surgery before, with an ECOG score of 0-1, an expected survival period of ≥ 3 months, with measurable or evaluable target lesions, no signs before esophageal perforation and no distant metastasis, and normal major organ function.

3. The use of radiotherapy combined with tegafur suppository in the treatment of inoperable elderly patients with advanced esophageal cancer according to claim 2, characterized in that: The criteria for normal function of the major organs are: routine blood examination standards must meet the requirements of no blood transfusion or blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction, HB≥100g / L, ANC≥1.5×109 / L, PLT≥100×109 / L; biochemical examinations must meet the requirements of TBIL<1.5′ULN, ALT and AST<2.0′ULN, serum Cr≤1.5′ULN or endogenous creatinine clearance>50ml / min; pulmonary function FEV1≥1.5L or>80% of the predicted value.

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