Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in Chi...Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in China.Methods:Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy.The primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer,appearance of a second primary or contralateral breast cancer,or death due to any cause.Other endpoints included the proportion of patients experiencing each event,incidence rate per annum,relationships between human epidermal growth factor receptor 2 status and time to event,and relationship between disease history variables and time to event.Results:Overall,558 patients were included in the full analysis set:397(71.1%)completed the study,20experienced an event,and 141 discontinued[47 owing to an adverse event(AE);37 no longer willing to participate].Median duration of treatment was 29.5(range,0.1-57.7)months.Median time to event was not reached.Eventfree survival probability at 36 months was 91.4%(95%CI,87.7%-95.1%).The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years(20/565).Multivariate analysis showed an association between tumor,lymph node,and metastasis stage at initial diagnosis and time to event[hazard ratio:1.532(95%CI,1.129-2.080);P=0.006].Most AEs were grade 1 or 2 in severity,with arthralgia(7.7%)being the most common treatment-related AE.Conclusions:This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+breast cancer previously treated with adjuvant tamoxifen for 2-3 years.No new safety signals were identified in the Chinese population.展开更多
Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC...Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC）.Patients and methods： A total of 98 MBC patients were treated with capecitabine combined with vinorelbine（NX）. Results： The median number of treatment was 6 cycles（1-7 cycles）. There were two cases of complete remission（CR）, 58 partial remission, 27 stable disease（SD）, 11 progression disease. The overall response rate（ORR）（CR ＋ PR） was 61.2%. The clinical benefit rate（CBR） was 75.5%. Fifty of effective patients received with capecitabine monotherapy as maintenance therapy. The ORR（CR ＋ PR） was 4%. The CBR was 48%. The median progression-free survival（PFS） was 12 months. In maintenance therapy or not, the median post metastasis survival rate（MSR） was 63 and 28 months, respectively. In the combination therapy group, the major grade 3/4 toxicities included hand-foot syndrome（3.1%）, skin pigmentation（2.0%）, diarrhoea and abdominal distension（5.1%）, stomatitis（1.0%）, and leukopenia（20.4%）.Conclusions： Capecitabine-based combination therapy and single-agent capecitabine maintenance therapy were well tolerated and effective to MBC.展开更多
文摘Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in China.Methods:Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy.The primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer,appearance of a second primary or contralateral breast cancer,or death due to any cause.Other endpoints included the proportion of patients experiencing each event,incidence rate per annum,relationships between human epidermal growth factor receptor 2 status and time to event,and relationship between disease history variables and time to event.Results:Overall,558 patients were included in the full analysis set:397(71.1%)completed the study,20experienced an event,and 141 discontinued[47 owing to an adverse event(AE);37 no longer willing to participate].Median duration of treatment was 29.5(range,0.1-57.7)months.Median time to event was not reached.Eventfree survival probability at 36 months was 91.4%(95%CI,87.7%-95.1%).The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years(20/565).Multivariate analysis showed an association between tumor,lymph node,and metastasis stage at initial diagnosis and time to event[hazard ratio:1.532(95%CI,1.129-2.080);P=0.006].Most AEs were grade 1 or 2 in severity,with arthralgia(7.7%)being the most common treatment-related AE.Conclusions:This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+breast cancer previously treated with adjuvant tamoxifen for 2-3 years.No new safety signals were identified in the Chinese population.
文摘Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC）.Patients and methods： A total of 98 MBC patients were treated with capecitabine combined with vinorelbine（NX）. Results： The median number of treatment was 6 cycles（1-7 cycles）. There were two cases of complete remission（CR）, 58 partial remission, 27 stable disease（SD）, 11 progression disease. The overall response rate（ORR）（CR ＋ PR） was 61.2%. The clinical benefit rate（CBR） was 75.5%. Fifty of effective patients received with capecitabine monotherapy as maintenance therapy. The ORR（CR ＋ PR） was 4%. The CBR was 48%. The median progression-free survival（PFS） was 12 months. In maintenance therapy or not, the median post metastasis survival rate（MSR） was 63 and 28 months, respectively. In the combination therapy group, the major grade 3/4 toxicities included hand-foot syndrome（3.1%）, skin pigmentation（2.0%）, diarrhoea and abdominal distension（5.1%）, stomatitis（1.0%）, and leukopenia（20.4%）.Conclusions： Capecitabine-based combination therapy and single-agent capecitabine maintenance therapy were well tolerated and effective to MBC.
