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Purpose@#This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice. @*Materials and Methods@#This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety. @*Results@#A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%). @*Conclusion@#Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.
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Objective:To examine the clinical value of combining indocyanine green (ICG) fluorescence navigation with blue dye in sen-tinel lymph node biopsy (SLNB) for patients with breast cancer. Methods:A total of 89 patients with early-stage breast cancer who met the inclusion criteria were admitted at Shantou Central Hospital, Guangdong from May 2013 to April 2014. In phase one, ICG and blue dye were applied in all 53 patients, and then SLNB and axillary lymph node dissection (ALND) were performed based on fluores-cence signal or visual sense of the lymph nodes. In phase two, 36 patients with early-stage breast cancer were included. ALND was omitted when sentinel lymph nodes were frozen showing negative result. Rates of detection, accuracy, and false-negative were calcu-lated. Results:A total of 89 patients were monitored, of which the total rate of SLNB detection was 96.6%(86/89). In the validation pe-riod, the rates of detection, accuracy, and false-negative were 94.3%(50/53) 98.0%(49/50), and 2.6%(1/38), respectively. In the alter-ative period, the rates of detection reached 100%. Of the 196 sentinel lymph nodes, 179 showed fluorescence signal, 142 exhibited blue dying, 54 only demonstrated fluorescence signals, and 45 demonstrated metastasis with five signaling fluorescence. About 24.7%of patients were diagnosed with SLN metastasis (22/89), where SLNB in two patients showed fluorescence signal but without blue dye. No ipsilateral lymph node relapsed were observed during a median follow up of 25 months. Conclusion:Combination of ICG fluores-cence navigation with blue dye in SLNB is safe for patients with breast cancer.
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Objective To investigate the significance of preoperative and postoperative enteral nutrition support in gastric cancer patients with nutritional risk.Methods The clinical data of 72 gastric cancer patients with nutritional risk admitted in our department were analyzed.All the patients were randomly allocated into two groups.36 patients in the control group received only intravenous nutrition postoperatively (PN group).36 patients in the treatment group received enteral nutrition support from the fifth day before operation to eighth day after operation (EN group).The body weight,total protein,albumin,transferrin and prealbumin were measured on the fifth day before operation,the operation morning,the first day and the eighth day after operation.Results On the operation morning,the transferrin and prealbumin of the EN group were higher than those in PN group significantly(P ＜0.05).In the eighth day after operation.the treatment group patients showed significant increase in the body weight,total protein,albumin,transferrin and prealbumin compared with those in the control group(P ＜ 0.05).On the operation morning,the transferrin and prealbmnin of EN group were increased significantly than on the fifth day before operation(P ＜ 0.01).Conclusion The preoperative and postoperative enteral nutritional support can improve the nutritlonal condition in the gastric cancer patients with nutritional risk.The preoperative enteral nutritional support can improve the patients' nutritlonal condition and reserves before operation,and reduce adverse reaction of enteral nutrition.
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ObjectiveTo explore the practicability and security of the ultracision harmonic scalpel in radical gastrectomy for patients with proximal gastric cancer.Methods115 patients of stage Ⅰ ～ Ⅲ proximal gastric cancer undergone radical gastrectomy were analyzed retrospectively.65 patients were performed with ultracision harmonic scalpel,the other 50 patients were performed with conventional operation.The operative time,volume of intraoperative hemorrhage,length of incision,and postoperative complications were analyzed.ResultsThere were significant difference in operative time ( 126.9 ± 20.7 ) min and ( 150.6 ± 31.7 ) min ( P ＜ 0.05 ),volume of intraoperative hemorrhage (105.7 ±40.3)ml and (171.7 ±63.2)ml(P＜0.01) and length of incision(17.2 ±2.1)cm and (20.3 ±2.3)cm (P ＜ 0.05 ).There was no significant difference in the postoperative complications between ultracisiou harmonic scalpel group and conventional group.All patients recovered without severe complications.ConclusionRadical resection of proximal gastric cancer using ultracision harmonic scalpel could shorten operative time,decrease intraoperative hemorrhage,shorten incision length,and the technique is convenient and safe.
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ObjectiveTo explore the effect of ultrasonic harmonic scalpel on stress after radical resction of esophageal carcinoma.MethodsAll 115 patients of esophageal carcinoma undergone radical esophagectomy were analyzed retrospectively.60 patients were performed with ultrasonic harmonic scalpel,the other 55 patients were performed with electrotome.The drainage volume of 72h after operation,postoperative complications and hospital days were analyzed.White blood cell count,Neu,CRP and blood glucose level were tested 2 days after operation.ResultsThere was significant difference in the drainage volume of 72h after operation (P ＜ 0.05 ),but the postoperative complications and hospital days had no obvious difference.White blood cell count,Neu,CRP and blood glucose were obviously increased after operation( all P ＜ 0.05 ) ;the barmonic scalpel group was dramatically decreased as compared with the electrotome group except blood glucose ( all P ＜ 0.05 ).ConclusionRadical resection of esophageal carcinoma using ultrasonic harmonic scalpel appears to decrease the drainage volume of 72h after operation and less the stress.
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Objective To investigate the optimal operative approach for esophageal and cardiac carcinoma,in order to obtain favorable exposure and to diminish trauma.Methods A method of median-rib-Section were performed in 207 cases of esophageal and cardiac carcinoma:the 6th and 7th ribs were cut intermediately,then we peeled and cut the rib periosteum.stretching the costal interspace with a prop until the exposure was optimal.Items including traumatic degree,exposure extend and conditions of thoracic cavity closure were compared with that of traditional antemposterior-rib-section method.Results The exposure result was similar in the two methods,but the traumatic de-grce WaS less when anteroposterior-rib·section was applied,due to its avoiding cutting intercostal muscles which caused more blood loss.The median-rib-section method led to more satisfactory anatomy paratope and external appearance,less trawma and incision pain.Conclusion The method of median-rib-section is worthy of generalization because of its satisfactory exposure,less trauma,better paratope and absence of postoperative costal malformation.
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Objective To examine the practicability and security of the LigaSureTM vessel-sealing system in radical gastrcctomy.Methods Seventy patients of stage Ⅰ～Ⅲ gastric cancer undergone radical gastrectomy were analyzed retrospectively.Thirty-five radical gastrectomy were performed with LigaSureTM vessel-sealing system,the other 35 eases were performed without LigaSureTM.The operative duration,volume of intraoperative hemorrhage,and postoperative complications were analyzed.Results There were significant difference in both operative duration[(159.9±24.7)min vs(172.6±23.7)min,P＜0.05]and volume of intraoperative hemorrhage[(335.7±40.3)ml vs(371.7±43.2)ml,P＜0.01].There was no significant difference in the postoperative complications between LigaSureTM group and conventional method group.All patients recovered without severe postoperative complications.Conclusion Radical resection of gastric cancer using LigaSureTM instead of conventional hand tie method appears to he shorten operative duration,decreased volume of intraoperative hemorrhage.And the technique is convenient and safe.
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Objective To compare the effect of two operative methods,median-rid-section and sub axillary median-rib-section.Methods 152 cases underwent by median-rib-section and among them 12 cases underwent by sub axillany median rib section.Results The median-rib-section procided a satisfact incision(the area of ineision was 14cm?30cm),without renobing the ribs,with the musculature.Complete,and less trauma.And the method of sub axillary median-rub-section had more intrathoracre esposure(the area of inclsion was 14cm?20cm),and the thoractomy could be done directly and satisfactory.Conclusion The median-rib section is a good method in thoraxoctomy which makes the ribs,made less trauma and provides satisfactory exposure,and after surgery,the chest is closed tighly.The sub axillary media rib section provides a wider application while remaining the good charactery of common sub axillary section.
