Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small s...Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.展开更多
Purpose: Endocrine therapy is one of the main treatment options for hormone receptor (HR)-positive advanced breast cancer (ABC). However, whether the combination of endocrine therapy with chemotherapy is practicable a...Purpose: Endocrine therapy is one of the main treatment options for hormone receptor (HR)-positive advanced breast cancer (ABC). However, whether the combination of endocrine therapy with chemotherapy is practicable and more effective than endocrine therapy alone remains unknown. The aim of this study was to investigate the clinical efficacy of the aromatase inhibitors (AIs) combined with metronomic capecitabine to provide the clinical evidence for further research in patients with HR-positive ABC. Methods: Data from 407 patients with HR-positive ABC were retrospectively analyzed. A total of 305 patients were given AIs alone, and 102 patients were given AIs plus capecitabine as first-line treatment. Progression-free survival (PFS) was the primary endpoint. Results: The median follow-up for all patients was 47.0 months (range, 3 - 119 months). The median overall survival (OS) and PFS were 52.0 months and 24.2 months, respectively. The median PFS in the combination group was significantly longer than that in the AIs group (22.0 months vs. 14.0 months, p = 0.002). Additionally, patients in the combination group had significantly longer OS than patients in the AI group (66.0 months vs. 49.0 months, p = 0.003). Multivariate analysis showed that combination therapy was a significant favorable predictor for PFS and OS. Furthermore, young age (<40 years), low estrogen receptor (ER) expression level (<40%), presence of visceral metastasis, prior adjuvant AI use and long disease-free interval (DFI) (>24 months) improved the benefit from combination therapy. Conclusions: AIs plus metronomic capecitabine significantly improves PFS and OS in patients with HR-positive ABC. Thus, chemo-endocrine therapy should be further explored.展开更多
Background:The introductions of anti-human epidermal growth factor receptor-2(HER2)agents have significantly improved the treatment outcome of patients with HER2-positive breast cancer.BAT8001 is a novel antibodydrug ...Background:The introductions of anti-human epidermal growth factor receptor-2(HER2)agents have significantly improved the treatment outcome of patients with HER2-positive breast cancer.BAT8001 is a novel antibodydrug conjugate targeting human epidermal growth factor receptor-2(HER2)-expressing cells composed of a trastuzumab biosimilar linked to the drug-linker Batansine.This dose-escalation,phase I study was designed to assess the safety,tolerability,pharmacokinetics,and preliminary anti-tumor activity of BAT8001 in patients with HER2-positive locally advanced or metastatic breast cancer.Methods:This trial was conducted in subjects with histologically confirmed HER2-positive breast cancer(having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1)using a 3+3 design of escalating BAT8001 doses.Patients received BAT8001 intravenously in a 21-day cycle,with dose escalation in 5 cohorts:1.2,2.4,3.6,4.8,and 6.0 mg/kg.The primary objective was to evaluate the safety and tolerability of BAT8001.Preliminary activity of BAT8001 was also assessed as a secondary objective.Results:Between March 2017 to May 2018,29 HER2-positive breast cancer patients were enrolled.The observed dose-limiting toxicities were grade 4 thrombocytopenia and grade 3 elevated transaminase.The maximum tolerated dose was determined to be 3.6 mg/kg.Grade 3 or greater adverse events(AEs)occurred in 14(48.3%)of 29 patients,including thrombocytopenia in 12(41.4%)patients,aspartate aminotransferase increased in 4(13.8%)patients,γ-glutamyl transferase increased in 2(6.9%)patients,alanine aminotransferase increased in 2(6.9%)patients,diarrhea in 2(6.9%)patients.Objective response was observed in 12(41.4%,95%confidence interval[CI]=23.5%-61.1%)and disease control(including patients achieving objective response and stable disease)was observed in 24(82.8%,95%CI=64.2%-94.2%)patients.Conclusions:BAT8001 demonstrated favorable safety profiles,with promising anti-tumor activity in patients with HER2-positive locally advanced or metastatic breast cancer.BAT8001 has the potential to provide a new therapeutic option in patients with metastatic HER2-positive breast cancer.展开更多
Background:Real-world data of the CM regimen[cyclophosphamide(CTX)plus methotrexate(MTX)]in metronomic pattern for advanced breast cancer is limited to small-sample or retrospective studies.This study was aimed to det...Background:Real-world data of the CM regimen[cyclophosphamide(CTX)plus methotrexate(MTX)]in metronomic pattern for advanced breast cancer is limited to small-sample or retrospective studies.This study was aimed to determine the effectiveness and safety of CM regimen in treating advanced breast cancer and to identify which patients are most likely to benefit from metronomic CM regimen.Methods:Patients with advanced breast cancer who received the metronomic CM regimen at least once between January 2009 and February 2019 in Sun Yat-sen University Cancer Center were included.Clinicopathological characteristics were collected.Overall survival(OS)and progression-free survival(PFS)were assessed using Kaplan-Meier estimates.Characteristics between patients with PFS<6 months and≥6 months were compared using the Chi-square test.Univariate and multivariate Cox regression model was used to estimate the prognostic factors for PFS and OS.Results:A total of 186 patients were included.The median age and follow-up were 49 years and 13.3 months,respectively.Over 50%of the patients were estrogen receptor/progesterone receptor-positive,and 60.8%had been heavily treated(≥3 lines).The objective response rate was 3.8%,the disease control rate at 12 weeks was 41.4%,and the clinical benefit rate at 24 weeks was 31.2%(58/186).The median PFS was 4.0 months[95%confidence interval(CI):3.6-4.7 months],the median duration of clinical benefit was 9.5 months(95%CI:8.2-10.8 months),and the median OS was 26.8 months(95%CI:20.9-37.7 months).Multivariate analysis for PFS revealed the CM regimen as maintenance therapy and no liver metastasis as favorable prognostic factors.Furthermore,patients without liver metastasis were more likely to have a PFS over 6 months than those with liver involvement(P=0.022).Liver,lymph node,and brain metastases were unfavorable prognostic factors for OS.The CM regimen was well-tolerated without newly reported adverse events.Conclusions:The CM regimen was effective in selected patients.In clinical practice,it would be better used as maintenance therapy and in patients without liver metastasis.Further follow-up investigation should be performed to examine its effect when used in combination with other treatments and determine predictive biomarkers.展开更多
Purpose:Chemotherapy-induced nail pigmentation is a common adverse efect,but prospective studies focussing on its onset,recovery,and severity are few.We aim to evaluate the pattern of chemotherapy-induced nail pigment...Purpose:Chemotherapy-induced nail pigmentation is a common adverse efect,but prospective studies focussing on its onset,recovery,and severity are few.We aim to evaluate the pattern of chemotherapy-induced nail pigmentation in early-stage breast cancer patients by calculating the comprehensive score based on hyperpigmentation area and color depth of the nail plate.Methods:This prospective,observational study was conducted between February 2019 and December 2019.Early-stage breast cancer patients scheduled to receive anthracyclines combined with cyclophosphamide or taxanecontaining regimens were enrolled.The clinicopathologic characteristics and treatment protocols were collected.The onset,patterns,and duration of nail changes were photographed and recorded regularly.Results:A total of 90 patients were enrolled.The most common nail change was nail pigmentation(n=81,90.0%),followed by onycholysis(n=39,43.3%),Beau’s lines(n=19,21.1%),Mees’lines(n=16,17.8%),Muehrcke’s lines(n=7,7.8%),and hemorrhage(n=1,1.1%).Forty-four(48.9%)patients developed severe nail pigmentation.The median onset time of nail pigmentation was 37 days after the initiation of chemotherapy.At the latest follow-up,55(67.9%)patients achieved remission of melanonychia with the median recovery time of 118 days.The median duration of nail pigmentation was 214 days.Conclusion:Our study revealed the specifc pattern of chemotherapy-induced nail pigmentation,which onsets early and recovers slowly with a high incidence of severe nail pigmentation,in early-stage breast cancer patients.The results provide reference for further intervention studies.Trial Registration:ClinicalTrials.gov Identifer:NCT04215744.Registered 30 December 2019—Retrospectively registered.展开更多
文摘Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.
文摘Purpose: Endocrine therapy is one of the main treatment options for hormone receptor (HR)-positive advanced breast cancer (ABC). However, whether the combination of endocrine therapy with chemotherapy is practicable and more effective than endocrine therapy alone remains unknown. The aim of this study was to investigate the clinical efficacy of the aromatase inhibitors (AIs) combined with metronomic capecitabine to provide the clinical evidence for further research in patients with HR-positive ABC. Methods: Data from 407 patients with HR-positive ABC were retrospectively analyzed. A total of 305 patients were given AIs alone, and 102 patients were given AIs plus capecitabine as first-line treatment. Progression-free survival (PFS) was the primary endpoint. Results: The median follow-up for all patients was 47.0 months (range, 3 - 119 months). The median overall survival (OS) and PFS were 52.0 months and 24.2 months, respectively. The median PFS in the combination group was significantly longer than that in the AIs group (22.0 months vs. 14.0 months, p = 0.002). Additionally, patients in the combination group had significantly longer OS than patients in the AI group (66.0 months vs. 49.0 months, p = 0.003). Multivariate analysis showed that combination therapy was a significant favorable predictor for PFS and OS. Furthermore, young age (<40 years), low estrogen receptor (ER) expression level (<40%), presence of visceral metastasis, prior adjuvant AI use and long disease-free interval (DFI) (>24 months) improved the benefit from combination therapy. Conclusions: AIs plus metronomic capecitabine significantly improves PFS and OS in patients with HR-positive ABC. Thus, chemo-endocrine therapy should be further explored.
基金This study was supported by the Natural Science Foundation of Guangdong Province(2020A1515010105)Joint Fund of the National Natural Science Foundation of China and Natural Science Foundation of Guangdong Province(U1601224).
文摘Background:The introductions of anti-human epidermal growth factor receptor-2(HER2)agents have significantly improved the treatment outcome of patients with HER2-positive breast cancer.BAT8001 is a novel antibodydrug conjugate targeting human epidermal growth factor receptor-2(HER2)-expressing cells composed of a trastuzumab biosimilar linked to the drug-linker Batansine.This dose-escalation,phase I study was designed to assess the safety,tolerability,pharmacokinetics,and preliminary anti-tumor activity of BAT8001 in patients with HER2-positive locally advanced or metastatic breast cancer.Methods:This trial was conducted in subjects with histologically confirmed HER2-positive breast cancer(having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1)using a 3+3 design of escalating BAT8001 doses.Patients received BAT8001 intravenously in a 21-day cycle,with dose escalation in 5 cohorts:1.2,2.4,3.6,4.8,and 6.0 mg/kg.The primary objective was to evaluate the safety and tolerability of BAT8001.Preliminary activity of BAT8001 was also assessed as a secondary objective.Results:Between March 2017 to May 2018,29 HER2-positive breast cancer patients were enrolled.The observed dose-limiting toxicities were grade 4 thrombocytopenia and grade 3 elevated transaminase.The maximum tolerated dose was determined to be 3.6 mg/kg.Grade 3 or greater adverse events(AEs)occurred in 14(48.3%)of 29 patients,including thrombocytopenia in 12(41.4%)patients,aspartate aminotransferase increased in 4(13.8%)patients,γ-glutamyl transferase increased in 2(6.9%)patients,alanine aminotransferase increased in 2(6.9%)patients,diarrhea in 2(6.9%)patients.Objective response was observed in 12(41.4%,95%confidence interval[CI]=23.5%-61.1%)and disease control(including patients achieving objective response and stable disease)was observed in 24(82.8%,95%CI=64.2%-94.2%)patients.Conclusions:BAT8001 demonstrated favorable safety profiles,with promising anti-tumor activity in patients with HER2-positive locally advanced or metastatic breast cancer.BAT8001 has the potential to provide a new therapeutic option in patients with metastatic HER2-positive breast cancer.
基金Joint Fund of National Natural Science Foundation of China,Grant/Award Number:U1601224Research Data Deposit,Grant/Award Number:RDDA2020001375。
文摘Background:Real-world data of the CM regimen[cyclophosphamide(CTX)plus methotrexate(MTX)]in metronomic pattern for advanced breast cancer is limited to small-sample or retrospective studies.This study was aimed to determine the effectiveness and safety of CM regimen in treating advanced breast cancer and to identify which patients are most likely to benefit from metronomic CM regimen.Methods:Patients with advanced breast cancer who received the metronomic CM regimen at least once between January 2009 and February 2019 in Sun Yat-sen University Cancer Center were included.Clinicopathological characteristics were collected.Overall survival(OS)and progression-free survival(PFS)were assessed using Kaplan-Meier estimates.Characteristics between patients with PFS<6 months and≥6 months were compared using the Chi-square test.Univariate and multivariate Cox regression model was used to estimate the prognostic factors for PFS and OS.Results:A total of 186 patients were included.The median age and follow-up were 49 years and 13.3 months,respectively.Over 50%of the patients were estrogen receptor/progesterone receptor-positive,and 60.8%had been heavily treated(≥3 lines).The objective response rate was 3.8%,the disease control rate at 12 weeks was 41.4%,and the clinical benefit rate at 24 weeks was 31.2%(58/186).The median PFS was 4.0 months[95%confidence interval(CI):3.6-4.7 months],the median duration of clinical benefit was 9.5 months(95%CI:8.2-10.8 months),and the median OS was 26.8 months(95%CI:20.9-37.7 months).Multivariate analysis for PFS revealed the CM regimen as maintenance therapy and no liver metastasis as favorable prognostic factors.Furthermore,patients without liver metastasis were more likely to have a PFS over 6 months than those with liver involvement(P=0.022).Liver,lymph node,and brain metastases were unfavorable prognostic factors for OS.The CM regimen was well-tolerated without newly reported adverse events.Conclusions:The CM regimen was effective in selected patients.In clinical practice,it would be better used as maintenance therapy and in patients without liver metastasis.Further follow-up investigation should be performed to examine its effect when used in combination with other treatments and determine predictive biomarkers.
文摘Purpose:Chemotherapy-induced nail pigmentation is a common adverse efect,but prospective studies focussing on its onset,recovery,and severity are few.We aim to evaluate the pattern of chemotherapy-induced nail pigmentation in early-stage breast cancer patients by calculating the comprehensive score based on hyperpigmentation area and color depth of the nail plate.Methods:This prospective,observational study was conducted between February 2019 and December 2019.Early-stage breast cancer patients scheduled to receive anthracyclines combined with cyclophosphamide or taxanecontaining regimens were enrolled.The clinicopathologic characteristics and treatment protocols were collected.The onset,patterns,and duration of nail changes were photographed and recorded regularly.Results:A total of 90 patients were enrolled.The most common nail change was nail pigmentation(n=81,90.0%),followed by onycholysis(n=39,43.3%),Beau’s lines(n=19,21.1%),Mees’lines(n=16,17.8%),Muehrcke’s lines(n=7,7.8%),and hemorrhage(n=1,1.1%).Forty-four(48.9%)patients developed severe nail pigmentation.The median onset time of nail pigmentation was 37 days after the initiation of chemotherapy.At the latest follow-up,55(67.9%)patients achieved remission of melanonychia with the median recovery time of 118 days.The median duration of nail pigmentation was 214 days.Conclusion:Our study revealed the specifc pattern of chemotherapy-induced nail pigmentation,which onsets early and recovers slowly with a high incidence of severe nail pigmentation,in early-stage breast cancer patients.The results provide reference for further intervention studies.Trial Registration:ClinicalTrials.gov Identifer:NCT04215744.Registered 30 December 2019—Retrospectively registered.
