Objective To analyze the dosimetric differences between Monaco Monte Carlo(MC)algorithm and Pinnacle collapse cone convolution(CCC)algorithm for the same machine model using the 6 MV flatten-filter free(FFF)mode,thus providing a reference for the clinical application of these two treatment planning systems.Methods According to the MPPG5 and TRS430 reports,the acceptance and commissioning of Monaco MC algorithm model and Pinnacle CCC algorithm model in Department of Radiation Oncology,Shenzhen Hospital,Cancer Hospital of Chinese Academy of Medical Sciences were performed.A retrospectively analysis was conducted on 30 cases,including 10 cases of nasopharyngeal cancer,6 cases of lung cancer,4 cases of esophageal cancer,and 10 cases of cervical cancer.For each case,a 6 MV FFF plan was designed in Pinnacle using CCC algorithm.A 2.5 mm dose grid was selected for plan optimization and dose calculation.The plan was then exported to Monaco,where dose to medium was calculated using MC algorithm and a 2.5 mm dose grid with a 1%uncertainty for each control point.Both calculations in Pinnacle and Monaco took into account the impact of the treatment couch and immobilization devices on dose attenuation.The dose differences to the target volumes and major organs at risk between Pinnacle and Monaco for 3 different body parts including the head,chest and abdomen were compared.Results(1)For nasopharyngeal cancer,compared with Pinnacle CCC algorithm,Monaco MC algorithm lowered the Vpd of PTVp,PTVn,PTVrpn,PTV1 and PTV2 by 9.98%,2.64%,15.0%,1.93%and 8.01%,elevated the Dmax of PTVp,PTVn and PTVrpn by 2.98%,5.62%and 2.39%,increased the Dmean of PTVn and PTV1 by 1.87%and 0.72%,respectively;and the Dmax of the brainstem,the Dmax of the optic chiasm,and the Dmean of the right parotid gland were 3.83%lower,7.03%higher and 1.32%higher in Monaco MC algorithm as compared with Pinnacle CCC algorithm,respectively.(2)For lung cancer and esophageal cancer,Monaco MC algorithm showed increases of 2.37%,4.18%,15.30%,6.36%and 1.04%in the Dmax of PGTV,the V20,V5 and Dmean of lungs,and the V30 of heart as compared with Pinnacle CCC algorithm,respectively.(3)For cervical cancer,the Vpd of PTV_LR,Dmax of PTV_LR,the V40 of the rectum,the Dmax of the small intestine,and the Dmean of humeral head were 7.70%lower,3.70%higher,4.31%lower,3.05%higher and 2.07%higher in Monaco MC algorithm than in Pinnacle CCC algorithm,respectively.These differences were statistically significant(P<0.05).Conclusion For the above 3 treatment sites,significant differences are found in dose calculations for target areas and organs at risk between Monaco MC algorithm and Pinnacle CCC algorithm for the same treatment plan.Attention should be paid to the differences in dose algorithms for different treatment planning systems in clinical applications,which may have impacts on patient survival rates and organ toxicity.

Objective:To compare the efficacy, safety, and cost-effectiveness of the trastuzumab originator (HST) versus its biosimilar (HLX02) combined with pertuzumab and chemotherapy as neoadjuvant treatment in patients with HER-2-positive breast cancer.Methods:This retrospective cohort study included 175 patients with HER-2-positive breast cancer who received neoadjuvant therapy followed by curative surgery at the Cancer Hospital Chinese Academy of Medical Sciences between October 2020 and January 2024. Patients were divided into two groups based on the trastuzumab formulation used: the HST group ( n=89) and the HLX02 group ( n=86).The efficacy, safety, and trastuzumab-related treatment costs were compared between the two groups. Moreover, using Logistic regression model to identify the factors influencing total pathological complete response (tpCR) rates. Results:There were statistically significant differences in clinical T stage and surgical approach between the HST and HLX02 groups ( P＜0.05). Other clinicopathological characteristics, such as age and histological grade, showed no statistically significant differences ( P＞0.05), with most baseline characteristics remaining balanced between the two groups. There were no significant differences in tpCR rates ( P=0.957) or Miller-Payne (MP) grading rates ( P=0.991) between the HST and HLX02 groups. The tpCR rates for the two groups were 55.1% (49/89) and 54.7% (47/86), respectively. The rates of achieving grade 5 (G5) in the postoperative MP pathological grading system were 55.1% (49/89) and 55.8% (48/86), respectively, with no statistically significant difference ( P=0.991). Univariate and multivariate Logistic regression analyses showed that hormone receptor status is an independent risk factor affecting tpCR ( OR=0.31, 95% CI; 0.16-0.61, P＜0.001). The incidence of adverse event during neoadjuvant therapy was similar between the groups, with no occurrences of trastuzumab-related cardiac toxicity. The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P＜0.05]. Conclusions:In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage.

Objective To analyze the dosimetric differences between Monaco Monte Carlo(MC)algorithm and Pinnacle collapse cone convolution(CCC)algorithm for the same machine model using the 6 MV flatten-filter free(FFF)mode,thus providing a reference for the clinical application of these two treatment planning systems.Methods According to the MPPG5 and TRS430 reports,the acceptance and commissioning of Monaco MC algorithm model and Pinnacle CCC algorithm model in Department of Radiation Oncology,Shenzhen Hospital,Cancer Hospital of Chinese Academy of Medical Sciences were performed.A retrospectively analysis was conducted on 30 cases,including 10 cases of nasopharyngeal cancer,6 cases of lung cancer,4 cases of esophageal cancer,and 10 cases of cervical cancer.For each case,a 6 MV FFF plan was designed in Pinnacle using CCC algorithm.A 2.5 mm dose grid was selected for plan optimization and dose calculation.The plan was then exported to Monaco,where dose to medium was calculated using MC algorithm and a 2.5 mm dose grid with a 1%uncertainty for each control point.Both calculations in Pinnacle and Monaco took into account the impact of the treatment couch and immobilization devices on dose attenuation.The dose differences to the target volumes and major organs at risk between Pinnacle and Monaco for 3 different body parts including the head,chest and abdomen were compared.Results(1)For nasopharyngeal cancer,compared with Pinnacle CCC algorithm,Monaco MC algorithm lowered the Vpd of PTVp,PTVn,PTVrpn,PTV1 and PTV2 by 9.98%,2.64%,15.0%,1.93%and 8.01%,elevated the Dmax of PTVp,PTVn and PTVrpn by 2.98%,5.62%and 2.39%,increased the Dmean of PTVn and PTV1 by 1.87%and 0.72%,respectively;and the Dmax of the brainstem,the Dmax of the optic chiasm,and the Dmean of the right parotid gland were 3.83%lower,7.03%higher and 1.32%higher in Monaco MC algorithm as compared with Pinnacle CCC algorithm,respectively.(2)For lung cancer and esophageal cancer,Monaco MC algorithm showed increases of 2.37%,4.18%,15.30%,6.36%and 1.04%in the Dmax of PGTV,the V20,V5 and Dmean of lungs,and the V30 of heart as compared with Pinnacle CCC algorithm,respectively.(3)For cervical cancer,the Vpd of PTV_LR,Dmax of PTV_LR,the V40 of the rectum,the Dmax of the small intestine,and the Dmean of humeral head were 7.70%lower,3.70%higher,4.31%lower,3.05%higher and 2.07%higher in Monaco MC algorithm than in Pinnacle CCC algorithm,respectively.These differences were statistically significant(P<0.05).Conclusion For the above 3 treatment sites,significant differences are found in dose calculations for target areas and organs at risk between Monaco MC algorithm and Pinnacle CCC algorithm for the same treatment plan.Attention should be paid to the differences in dose algorithms for different treatment planning systems in clinical applications,which may have impacts on patient survival rates and organ toxicity.

Objective:To compare the efficacy, safety, and cost-effectiveness of the trastuzumab originator (HST) versus its biosimilar (HLX02) combined with pertuzumab and chemotherapy as neoadjuvant treatment in patients with HER-2-positive breast cancer.Methods:This retrospective cohort study included 175 patients with HER-2-positive breast cancer who received neoadjuvant therapy followed by curative surgery at the Cancer Hospital Chinese Academy of Medical Sciences between October 2020 and January 2024. Patients were divided into two groups based on the trastuzumab formulation used: the HST group ( n=89) and the HLX02 group ( n=86).The efficacy, safety, and trastuzumab-related treatment costs were compared between the two groups. Moreover, using Logistic regression model to identify the factors influencing total pathological complete response (tpCR) rates. Results:There were statistically significant differences in clinical T stage and surgical approach between the HST and HLX02 groups ( P＜0.05). Other clinicopathological characteristics, such as age and histological grade, showed no statistically significant differences ( P＞0.05), with most baseline characteristics remaining balanced between the two groups. There were no significant differences in tpCR rates ( P=0.957) or Miller-Payne (MP) grading rates ( P=0.991) between the HST and HLX02 groups. The tpCR rates for the two groups were 55.1% (49/89) and 54.7% (47/86), respectively. The rates of achieving grade 5 (G5) in the postoperative MP pathological grading system were 55.1% (49/89) and 55.8% (48/86), respectively, with no statistically significant difference ( P=0.991). Univariate and multivariate Logistic regression analyses showed that hormone receptor status is an independent risk factor affecting tpCR ( OR=0.31, 95% CI; 0.16-0.61, P＜0.001). The incidence of adverse event during neoadjuvant therapy was similar between the groups, with no occurrences of trastuzumab-related cardiac toxicity. The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P＜0.05]. Conclusions:In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage.

Objective:To compare the mid-term clinical effects of AngioJet rheolytic thrombectomy assisted catheter-directed thrombolysis (ART+CDT) with catheter-directed thrombolysis (CDT) in the treatment of acute deep venous thrombosis of lower extremities.Methods:Ninety-one patients admitted to the Department from Jan 2016 to Dec 2017 were placed with inferior vena cava filters and divided into ART+CDT group (30 cases)and CDT group (61 cases). Total urokinase dosge, thrombolytic time, operative cost, length of hospital stay, detumescence rate, thrombus clearance rate, cumulative patency rate of lower limb veins, Villalta score at 2 years and 5 years, thrombosis recurrence rate and chronic venous insufficiency quality of life questionnaire were compared between the two groups.Results:The success rate of surgery was 100% in both groups, there was no mortality. There were significant differences in the short-term postoperative outcomes between the two groups in terms of total dosage of urokinase, thrombolysis time, total cost of surgery, length of hospital stay, detumescence rate, venous patency scores before and after treatment, and venous patency rate (all P<0.05). For the mid- and long-term postoperative outcomes of 2 and 5 years, there were no significant differences in the incidence of PTS, recurrence rate of thrombus, chronic venous function scale, and cumulative patency rate at 2 years (all P>0.05). Conclusions:ART+CDT has a significant advantage over CDT alone in terms of early efficacy and early reopening of blood flow in patients. Both ART+CDT and CDT have a low incidence of PTS and a low recurrence rate of thrombus in the mid-term follow-up, and both have satisfactory performance in the mid- and long-term efficacy of interventional treatment of deep venous thrombosis of lower limbs.

Objective:To compare the impact of Monte Carlo (MC) algorithm grid spacing (GS) and statistical uncertainty (SU) of Monaco on clinical plan validation gamma pass rate, and to provide reference for daily patient-specific quality assurance (PSQA).Methods:Twenty patients treated in Chinese Academy of Medical Sciences and Peking Union Medical College Cancer Hospital & Shenzhen Hospital from July to November 2023 were retrospectively selected, including 5 cases of nasopharyngeal carcinoma in the head, 2 cases of lung cancer, 3 cases of esophageal cancer, 5 cases of breast cancer in the chest, 4 cases of cervical cancer, 1 case of rectal cancer in the abdomen, respectively. All selected patient plans were re-measured on the same day by the same physicist on the same machine to obtain dose distribution files. Three types of GS of Monaco, including 2 mm, 3 mm, and 4 mm (GS2、GS3、GS4), and 5 types percentage of SU, including SU CP1, SU CP2, SU CP3, SU CP4, and SU CL1 were selected. The validation plans were recalculated, with a total of 15 validation plans for each clinical plan. Using a 3%/2 mm evaluation standard, the gamma pass rates of each plan at different GS and SU were analyzed. The gamma pass rates of different GS and SU in the same case plan were analyzed by paired sample t-test. Results:Based on the gamma pass rate of GS2, the differences in gamma pass rates between different GS for the same SU were statistically significant (all P<0.05). For SU CP1, the gamma pass rates of GS3 and GS4 were decreased by 0.4% and 1.4% compared to GS2, respectively. For SU CP2, the gamma pass rates of GS3 and GS4 were decreased by 0.5% and 1.5% compared to GS2, respectively. For SU CP3, the gamma pass rates of GS3 and GS4 were decreased by 0.5% and 1.5% compared to GS2, respectively. For SU CP4, the gamma pass rates of GS3 and GS4 were decreased by 0.5% and 1.5% compared to GS2, respectively. For SU CL1, the gamma pass rates of GS3 and GS4 were decreased by 0.7% and 2.0% compared to GS2, respectively. Based on the gamma pass rate of SU CP1, for the same GS but different SU, there was no statistically significant difference in the gamma pass rate of the SU selected in this study at GS2. However, at GS3 and GS4, the difference between SU CP4 and SU CL1 compared to SU CP1 was statistically significant (at GS3, P=0.049 and 0.012; at GS4, P=0.045 and <0.001), with gamma pass rates reduced by 0.1%, 0.4%, 0.2% and 0.6%, respectively. Conclusions:Both GS and SU values affect the gamma pass rate of PSQA to a certain extent. It is recommended to use Monaco MC algorithm for daily PSQA, selecting GS2 and SU with SU CL1 to calculate the validation plan.

Objective To observe the role of empagliflozin tablets combined with benazepril hydrochloride tablets on clinical efficacy and renal outcomes in treating type 2 diabetic kidney disease(DKD).Methods Patients with type 2 DKD were divided into treatment group and control group by means of the random number table method.The control group was treated with benazepril hydrochloride tablets(10 mg,qd)and the treatment group was treated with empagliflozin tablets on the basis of the control group.The initial dose was 10 mg,qd,adjusted to 25 mg after tolerance,qd.Two groups were treated for 3 months.The clinical efficacy,blood glucose indexes[fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1 c)],renal function indexes[serum creatinine(SCr),glomerular filtration rate(eGFR)],oxidative stress indexes[superoxide dismutase(SOD),malondialdehyde(MDA)],renal outcomes and safety were compared between the two groups before and after treatment.Results In the treatment group,63 cases were enrolled,2 cases were lost,and 61 cases were finally included in the statistical analysis.In the control group,63 cases were enrolled,2 cases were lost,and finally 61 cases were included in the statistical analysis.After treatment,the total effective rates in treatment group and control group were 88.52％(54 cases/61 cases)and 73.77％(45 cases/61 cases),respectively(P＜0.05).After treatment,the peripheral blood FPB levels in treatment group and control group were(5.64±0.58)and(6.31±0.79)mmol·L-1;HbA1c levels were(6.09±0.75)％and(6.94±0.96)％;SCr levels were(111.88±11.45)and(119.41±8.31)μmol·L-1;eGFR values were(64.11±9.04)and(58.92±4.79)mL·min-1·1.73 m-2;SOD levels were(45.72±5.53)and(39.54±3.97)U·mL-1;MDA levels were(26.18±3.22)and(30.31±3.65)nmol·mL-1;the incidence rates of adverse renal outcomes were 6.56％(4 cases/61 cases)and 19.67％(12 cases/61 cases),respectively,with statistical differences(all P＜0.05).The adverse drug reactions in treatment group were mainly urinary tract infection,hypoglycemia and headache,and those in control group were mainly hypotension and headache.The incidence rates of adverse drug reactions were 9.84％(6 cases/61 cases)and 6.56％(4 cases/61 cases),respectively(P＞0.05).Conclusion The clinical efficacy of empagliflozin tablets combined with benazepril hydrochloride tablets in the treatment of type 2 DKD is better,which can reduce the incidence of adverse renal outcomes without increasing adverse drug reactions.

Objective To observe the role of empagliflozin tablets combined with benazepril hydrochloride tablets on clinical efficacy and renal outcomes in treating type 2 diabetic kidney disease(DKD).Methods Patients with type 2 DKD were divided into treatment group and control group by means of the random number table method.The control group was treated with benazepril hydrochloride tablets(10 mg,qd)and the treatment group was treated with empagliflozin tablets on the basis of the control group.The initial dose was 10 mg,qd,adjusted to 25 mg after tolerance,qd.Two groups were treated for 3 months.The clinical efficacy,blood glucose indexes[fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1 c)],renal function indexes[serum creatinine(SCr),glomerular filtration rate(eGFR)],oxidative stress indexes[superoxide dismutase(SOD),malondialdehyde(MDA)],renal outcomes and safety were compared between the two groups before and after treatment.Results In the treatment group,63 cases were enrolled,2 cases were lost,and 61 cases were finally included in the statistical analysis.In the control group,63 cases were enrolled,2 cases were lost,and finally 61 cases were included in the statistical analysis.After treatment,the total effective rates in treatment group and control group were 88.52％(54 cases/61 cases)and 73.77％(45 cases/61 cases),respectively(P＜0.05).After treatment,the peripheral blood FPB levels in treatment group and control group were(5.64±0.58)and(6.31±0.79)mmol·L-1;HbA1c levels were(6.09±0.75)％and(6.94±0.96)％;SCr levels were(111.88±11.45)and(119.41±8.31)μmol·L-1;eGFR values were(64.11±9.04)and(58.92±4.79)mL·min-1·1.73 m-2;SOD levels were(45.72±5.53)and(39.54±3.97)U·mL-1;MDA levels were(26.18±3.22)and(30.31±3.65)nmol·mL-1;the incidence rates of adverse renal outcomes were 6.56％(4 cases/61 cases)and 19.67％(12 cases/61 cases),respectively,with statistical differences(all P＜0.05).The adverse drug reactions in treatment group were mainly urinary tract infection,hypoglycemia and headache,and those in control group were mainly hypotension and headache.The incidence rates of adverse drug reactions were 9.84％(6 cases/61 cases)and 6.56％(4 cases/61 cases),respectively(P＞0.05).Conclusion The clinical efficacy of empagliflozin tablets combined with benazepril hydrochloride tablets in the treatment of type 2 DKD is better,which can reduce the incidence of adverse renal outcomes without increasing adverse drug reactions.

Humans ; Atrial Fibrillation/surgery* ; Catheter Ablation

Objective: Explore the association between atrial fibrillation (AF) reoccurrence and new-onset ischemic stroke (IS) in patients with nonvalvular AF, and explore whether there is a high-risk period of IS after recurrent episodes of AF. Methods: A nested case-control study design was used. A total of 565 nonvalvular AF patients with new-onset IS after a follow-up of at least 2 years in the China-AF cohort were enrolled as the case group, and 1 693 nonvalvular AF patients without new-onset IS were matched as the control group at a ratio of 1∶3. Frequency and types of recurrent AF in the previous 1 or 2 years were compared between two groups, and the adjusted associations of AF reoccurrence with new onset IS were explored using conditional logistic regression analysis. The proportion of recurrent AF was compared between the case period and control period, and conditional logistic regression analysis was performed to calculate adjusted associations of case-period AF with IS. Results: The nested case-control study design results showed that the proportion of at least one record of recurrent AF in the previous 1 year was higher in the case group than in the control group (72.0% vs. 60.8%, P<0.05), and the recurrent AF was positively correlated with new-onset IS (adjusted OR=1.80, P<0.001). Similar results were also observed in the previous 2 years period. The case-crossover study design analysis showed that among 565 patients with new-onset IS, recurrent AF in the case period was positively correlated with IS (adjusted OR=1.61, P=0.003). Conclusion: Recurrent AF is associated with IS, and there may be a high-risk period of IS after recurrent episodes of AF.
Humans ; Atrial Fibrillation/epidemiology* ; Case-Control Studies ; Cross-Over Studies ; Ischemic Stroke ; China/epidemiology*