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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 analyze clinicopathologic characteristics and prognostic factors of the patients with invasive lobular carcinoma of breast. Methods Clinical data of 125 patients with invasive lobular carcinoma of breast treated at Cancer Center of Sun Yat-sen University from Jan. 1990 to Dec. 2008, were analyzed. The clinical characteristics, recurrence and survival of the patients were summarized. Results Median age of 125 patients was 45 years old (range, 27 to 76 years old). The patients with large tumor mass (≥ 3cm), positive local lymph node, more than Ⅱ stage and positive hormone receptor at diagnosis were 77 cases(61.6 %), 64 cases(51.2 %), 101 cases(80.8 %) and 112 cases(89.6 %), respectively. The median time of follow-up was 58 months (range, 11-222 months). Of the 125 patients, 32 had local recurrence and metastasis, and 18 died. The 5-year disease-free and overall survival rates were 82.2 % and 87.3 %, respectively. Multivariate COX regression analysis showed that whether endocrine therapy or not was only a prognostic factor of patients with invasive lobular carcinoma of breast. Conclusion There is no difference in media age of patients with invasive lobular carcinoma of breast at diagnosis from other pathologic type of breast cancer. These patients are usually with larger tumor masses, more lymph node metastasis and a higher proportion of positive hormone receptor. The prognosis of patients is not affected by clinicopathologic parameters.
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Objective To define that human cytomegalovirus (HCMV) can cross the placenta of the Balb/c mice and induce liver damage in developing fetus. Methods HCMV AD169 (6.0 logTCID 50 , 3.0 logTCID 50 , 1.5 logTCID 50 per mouse respectively) was injected into the peritoneum of mice (half of mice were female) when they were about 10 weeks old (weight 25 30g). Then, these mice were paired to mate. Fetus on day about to give birth was removed from the uterus and liver was obtained for virus isolation, pathological studies, examination of the viral DNA positive cells by in situ hybridization using digoxigenin labelled HCMV DNA oligonucleotide probe. Results HCMV could be isolated from the supernatant of tissues; HCMV DNA was found by PCR in supernatant of cell culture with CPE; the presence of viral DNA sequence in hepatocytes was confirmed by in situ hybridization; pathological changes in liver consist of swollen cytoplasm and destroyed nuclei of hepatocytes and distinct intranuclear inclusion in hepatocytes with a cellular infiltrates of predominantly phagocytic cells. All above were found more obviously in fetal mouse liver tissues from the group inoculated with 6.0 log TCID 50 HCMV AD169 as compared with 3.0 log TCID 50 group. In contrast, these positive results couldn't be well found in 1.5 log TCID 50 group. Nothing could be found in normal controls. Conclusions Our research suggests that primary maternal HCMV infection during pregnancy could induce congenital infection in fetus by transplacental transmission and induce fetal liver damage. The mouse model will provide the basis for the study on pathogenesis of congenital HCMV infection in liver and the development of prevention, diagnosis and antiviral agents for congenital HCMV infection in human being.
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Purpose:To evaluate the efficacy and toxicity o f intratumoral H101, an E1B deleted oncolytic adenovires. Methods :A total of 53 patients with malignant tumors from multiple centers were treated with H101, 5?10 11 viral particle (VP) per day for 5 consecutive days ever y three weeks. The efficacy and toxicity were evaluated. Results :Among 49 evaluable cases, complete response 2, partial response 9, minimal respo nse 8, stable disease 19, progressive disease 11, overall response rate was 22.4 %. In the 56 ITT population the response rate was 19.6%, including 2 CR and 9 PR . The rate of clinical benefit response (CR+PR+MR+SD) was 77.6% (38/49). Main si de effects were injection site pain (57.4%) and fever (35.2%). No serious advers e events developed. Conclusions:The study showed that genetical ly E1B-deleted adenovirus (H101) showed some efficacy in some refractory malign ant tumors, and was well tolerated.