1.Comparison of the efficacy, safety, and cost-effectiveness of trastuzumab biosimilar HLX02 and the originator combined with pertuzumab and chemotherapy in the neoadjuvant treatment of patients with HER-2-positive breast cancer
Zixuan LEI ; Die SANG ; Bo LAN ; Ying FAN ; Ruigang CAI ; Yang LUO ; Qiao LI ; Jiayu WANG ; Longmei ZHAO ; Peng YUAN
Chinese Journal of Oncology 2025;47(6):517-524
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.
2.Comparison of the efficacy, safety, and cost-effectiveness of trastuzumab biosimilar HLX02 and the originator combined with pertuzumab and chemotherapy in the neoadjuvant treatment of patients with HER-2-positive breast cancer
Zixuan LEI ; Die SANG ; Bo LAN ; Ying FAN ; Ruigang CAI ; Yang LUO ; Qiao LI ; Jiayu WANG ; Longmei ZHAO ; Peng YUAN
Chinese Journal of Oncology 2025;47(6):517-524
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.
3.Prevention and management of VKC in China from the Asian VKC expert consensus
Xiuming JIN ; Zixuan CAI ; Ning WANG
Chinese Journal of Experimental Ophthalmology 2024;42(2):165-171
The Asian expert working group completed the 2022 consensus on vernal keratitis (VKC), which provides detailed information on the definition, classification, clinical manifestation, diagnosis and treatment of VKC in Asia and identifies unmet treatment needs, including: (1) lack of clear criteria for the diagnosis and treatment of patients with VKC.The pathogenesis of the disease is unclear, and anti-allergy therapy is often ineffective in patients with moderate or severe VKC; (2) the need for standardized treatment and management strategies.Treatment and management of patients with the same severity varies widely among Asian countries, with a lack of clear, standardized guidelines and grading systems; (3) safety and iatrogenic complications; (4) optimal dosing regimen for pharmacologic treatment.In this article, the aspects mentioned above were interpreted and analyzed in the context of the Expert Consensus on the Diagnosis and Treatment of Allergic Conjunctivitis in China ( 2018), with a view to helping the prevention and treatment of VKC in China.
4.Clinical value of endoscopic intervention in preventing rebleeding of Forrest Ⅱb ulcers
Fei LIU ; Zhenyun GONG ; Zixuan CAI ; Jing ZHAO ; Qinkai LI ; Guilian CHENG ; Wei WU ; Xuexin XU ; Duanmin HU
China Journal of Endoscopy 2024;30(12):36-42
Objective To explore the clinical value of endoscopic intervention in preventing rebleeding of Forrest Ⅱb grade ulcers.Method A retrospective analysis was conducted on the clinical data of 114 patients from January 2015 to April 2023 due to gastrointestinal bleeding,who were confirmed by gastroscopy as Forrest Ⅱb grade ulcers.86 (75.4%,86/114) patients received endoscopic treatment as endoscopic treatment group,while 28 patients only received medication treatment as medication treatment group.Compare the effectiveness of endoscopic treatment and different endoscopic hemostatic methods for preventing rebleeding.Results There were no statistically significant differences in age,gender,clinical symptom,systolic pressure,hemoglobin concentration,and ulcer site between endoscopic and medication treatment patients (P>0.05).In terms of ulcer size,the length of ulcer in the endoscopic treatment group was smaller than that in the medication treatment group[(9.5±5.3) mm vs (12.8±7.7) mm],the difference was statistically significant (P=0.013).The rebleeding rate of medication treatment group was 21.4% (6/28);Among the endoscopic treatment group,85 patients (98.8%,85/86) successfully underwent endoscopic treatment,with a rebleeding rate of 11.8% (10/85),which was lower than that of medication treatment group,but the difference was not statistically significant (P=0.337).Among the patients who successfully underwent endoscopic treatment,62 cases were treated with injection of diluted adrenaline alone,6 cases with titanium clips,and 17 cases were treated with electrocoagulation or electrocoagulation combined with other hemostatic methods.The rebleeding rate were 12.9% (8/62),16.7% (1/6),and 5.9% (1/17),respectively,which were lower than that of medication treatment patients,but the difference was not statistically significant (P=0.474).Due to the need for endoscopic treatment,15 patients were treated with a snare or thermal hemostatic forceps to remove the surface blood clot of the ulcer.Among them,3 cases had jet bleeding at the base (2 cases were successfully stopped by electrocoagulation;1 case had a large amount of bleeding,but endoscopic hemostasis failed,and intervention embolization successfully stopped the bleeding).Among of 16 patients with rebleeding,3 patients were treated with conservative management,and all of them were successfully stopped bleeding;6 cases underwent endoscopic treatment again,of which 4 cases were successfully hemostasis by endoscopy,and 2 cases were successfully hemostasis by surgery after endoscopic hemostasis failure;interventional embolization in 1 case,and successfully hemostasis;6 patients underwent direct surgical procedures,all of which successfully stopped bleeding,but one patient developed multiple organ failure during hospitalization and died without bleeding.Conclusion Endoscopic intervention can to some extent reduce the incidence of rebleeding in Forrest Ⅱb grade ulcers.The effect of electrocoagulation hemostasis on preventing rebleeding is better than that of injection dilution adrenaline method.However,there is a risk of iatrogenic rebleeding when removing blood clots on the surface of ulcers,and careful selection should be made when conditions permit.
5.Clinical value of endoscopic intervention in preventing rebleeding of Forrest Ⅱb ulcers
Fei LIU ; Zhenyun GONG ; Zixuan CAI ; Jing ZHAO ; Qinkai LI ; Guilian CHENG ; Wei WU ; Xuexin XU ; Duanmin HU
China Journal of Endoscopy 2024;30(12):36-42
Objective To explore the clinical value of endoscopic intervention in preventing rebleeding of Forrest Ⅱb grade ulcers.Method A retrospective analysis was conducted on the clinical data of 114 patients from January 2015 to April 2023 due to gastrointestinal bleeding,who were confirmed by gastroscopy as Forrest Ⅱb grade ulcers.86 (75.4%,86/114) patients received endoscopic treatment as endoscopic treatment group,while 28 patients only received medication treatment as medication treatment group.Compare the effectiveness of endoscopic treatment and different endoscopic hemostatic methods for preventing rebleeding.Results There were no statistically significant differences in age,gender,clinical symptom,systolic pressure,hemoglobin concentration,and ulcer site between endoscopic and medication treatment patients (P>0.05).In terms of ulcer size,the length of ulcer in the endoscopic treatment group was smaller than that in the medication treatment group[(9.5±5.3) mm vs (12.8±7.7) mm],the difference was statistically significant (P=0.013).The rebleeding rate of medication treatment group was 21.4% (6/28);Among the endoscopic treatment group,85 patients (98.8%,85/86) successfully underwent endoscopic treatment,with a rebleeding rate of 11.8% (10/85),which was lower than that of medication treatment group,but the difference was not statistically significant (P=0.337).Among the patients who successfully underwent endoscopic treatment,62 cases were treated with injection of diluted adrenaline alone,6 cases with titanium clips,and 17 cases were treated with electrocoagulation or electrocoagulation combined with other hemostatic methods.The rebleeding rate were 12.9% (8/62),16.7% (1/6),and 5.9% (1/17),respectively,which were lower than that of medication treatment patients,but the difference was not statistically significant (P=0.474).Due to the need for endoscopic treatment,15 patients were treated with a snare or thermal hemostatic forceps to remove the surface blood clot of the ulcer.Among them,3 cases had jet bleeding at the base (2 cases were successfully stopped by electrocoagulation;1 case had a large amount of bleeding,but endoscopic hemostasis failed,and intervention embolization successfully stopped the bleeding).Among of 16 patients with rebleeding,3 patients were treated with conservative management,and all of them were successfully stopped bleeding;6 cases underwent endoscopic treatment again,of which 4 cases were successfully hemostasis by endoscopy,and 2 cases were successfully hemostasis by surgery after endoscopic hemostasis failure;interventional embolization in 1 case,and successfully hemostasis;6 patients underwent direct surgical procedures,all of which successfully stopped bleeding,but one patient developed multiple organ failure during hospitalization and died without bleeding.Conclusion Endoscopic intervention can to some extent reduce the incidence of rebleeding in Forrest Ⅱb grade ulcers.The effect of electrocoagulation hemostasis on preventing rebleeding is better than that of injection dilution adrenaline method.However,there is a risk of iatrogenic rebleeding when removing blood clots on the surface of ulcers,and careful selection should be made when conditions permit.
6.Preoperative localization value of endoscopic ultrasound guided fine needle tattooing for laparoscopic distal pancreatectomy in pancreatic lesions with a maximum diameter ≤3 cm
Fei LIU ; Zixuan CAI ; Yuanling SHE ; Guilian CHENG ; Liming XU ; Shaohua WEI ; Dekang GAO ; Duanmin HU ; Wei WU
Chinese Journal of Digestion 2023;43(12):806-811
Objective:To evaluate the preoperative localization value of endoscopic ultrasound guided fine needle tattooing (EUS-FNT) for laparoscopic distal pancreatectomy in pancreatic lesions with a maximum diameter ≤3 cm.Methods:From November 2017 to October 2022, at the Second Affiliated Hospital of Soochow University, the data of patients with pancreatic lesions ≤3 cm who underwent laparoscopic distal pancreatectomy were retrospectively analyzed. Eight patients who underwent EUS-FNT assisted laparoscopic distal pancreatectomy were included in the fine needle tattooing (FNT) combined laparoscopic group. And 14 patients who underwent simple laparoscopic distal pancreatectomy were taken as the simple laparoscopic group. The success rate and complications of EUS-FNT were observed. The differences in operation time, surgery-related complications and complete resection rate of lesions between the two groups were compared. Mann-Whitney U test and descriptive analysis were used for statistical analysis. Results:In the FNT combined laparoscopic group, the lesions of 4 cases were located in the pancreatic body and 4 cases in the pancreatic tail. In the simple laparoscopic group, the lesions of 4 cases were located in the pancreatic body and 10 cases in the pancreatic tail. There was a significant difference in lesion size between the two groups (14.5 mm (10.8 mm, 16.5 mm) vs. 27.0 mm (23.5 mm, 30.0 mm), Z=-3.09, P=0.001). In the FNT combined laparoscopic group, EUS-FNT was successfully performed in all 8 patients. The average time of laparoscopy after EUS-FNT was (98.4±8.8) min. The marks were clearly visible under the laparoscopic field of view, and no complications such as abdominal hemorrhage and hematoma were observed. Laparoscopic pancreaticocaudectomy was performed in 5 cases and pancreaticocaudectomy plus splenectomy in 3 cases. The median operation time was 192.5 min (176.3 min, 203.8 min). The amount of intraoperative bleeding was large in 2 patients and blood transfusion was needed. The lesions were one-time completely resected in all 8 patients. The postoperative pathology were 6 cases of pancreatic neuroendocrine neoplasm, 1 case of intraductal papillary mucinous neoplasm (IPMN), and 1 case of solid pseudopapilloma. In the simple laparoscopic group, laparoscopic pancreaticocaudectomy was performed in 2 cases and pancreaticocaudectomy plus splenectomy in 12 cases. The median operation time was 202.5 min (192.8 min, 235.0 min), which was longer than that of FNT combined laparoscopic group, but the difference was not statistically significant ( P>0.05). The amount of intraoperative bleeding was large in 2 patients and blood transfusion was needed. In 1 patient with pancreatic body lesions, no lesion was found in the specimen examination after the first pancreatectomy, and the lesions were completely resected after the second partial pancreatectomy. Active abdominal hemorrhage occurred in 1 patient on the second day after operation, and underwent interventional embolization for hemostasis. Two weeks after surgery, 1 patient was found to have a encapsulated fluid with a long diameter of 6 cm around the pancreas by computed tomography re-examination 2 weeks after surgery. The postoperative pathology were 5 cases of pancreatic neuroendocrine neoplasm, 2 cases of IPMN, 1 case of solid pseudopapilloma, 1 case of pancreatic cyst with glandular low-grade intraepithelial neoplasia, 1 case of ectopic spleen, and 4 cases of pancreatic ductal adenocarcinoma. Conclusion:EUS-FNT can effectively localize small pancreatic lesions before laparoscopic distal pancreatectomy, shorten the operation time and improve the complete resection rate under laparoscopy.

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