1.Multi-center real world study of the efficacy and safety of albumin-bound paclitaxel in the treatment of advanced breast cancer
Die SANG ; Hua ZHOU ; Hong ZONG ; Hua YANG ; Qianrun LU ; Shanmin FAN ; Yuchi WANG ; Lihua SONG ; Peng YUAN
Chinese Journal of Oncology 2021;43(10):1114-1121
Objective:To observe the efficacy and safety of albumin-bound paclitaxel in the treatment of metastatic breast cancer.Methods:Multi-center data of patients who accepted single-drug albumin-bound paclitaxel or combination regimens from 2013 to 2019 were collected and the efficacy and safety were evaluated. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates.Results:A total of 203 advanced breast cancer cases were enrolled. The median progression-free survival time (PFS) lasted for 4 months, the median overall survival(OS)was 14 months, objective response rate (ORR) was 36.0% while the disease control rate (DCR) was 81.3%. The ORRs of Luminal, human epidermal growth factor receptor 2 (HER2) overexpression and triple-negative breast cancer patients underwent albumin-bound paclitaxel treatment were 37.3%, 45.5% and 31.0%, respectively, the DCRs were 85.5%, 68.2% and 78.9%, respectively. The OS of patients with relapse or metastasis who accepted less than two and more than two chemotherapy regimens were 22 months and 11 months ( P<0.000 1), the ORRs were 44.9% vs 30.4%, DCRs were 87.2% vs 77.6% ( P=0.018). The ORR and DCR of patients who accepted traditional paclitaxel treatment before the albumin-bound paclitaxel treatment were 35.8% and 82.1%, respectively. The common adverse reaction of these patients was numbness of limbs, which incidence rate was 64.5% (131/203), and 61.1% (124/203) were degree 1 to 2. Other adverse reactions including decreased white blood cells, which incidence rate was 56.1% (114/203); nausea and vomit, which incidence rate was 36.9% (75/203); anemia, which incidence rate was 21.2% (43/203); decreased platelet, which incidence rate was 18.7% (38/203); hepatic dysfunction, which incidence rate was 18.2% (37/203). Conclusions:Albumin-bound paclitaxel single or combination regimen is still significant efficient for various molecular subtypes of breast cancer patients or patients with traditional paclitaxel resistance or multi-line chemotherapy failure. Early usage has better prognosis, controllable adverse reaction and prominent clinical application value.
2.Multi-center real world study of the efficacy and safety of albumin-bound paclitaxel in the treatment of advanced breast cancer
Die SANG ; Hua ZHOU ; Hong ZONG ; Hua YANG ; Qianrun LU ; Shanmin FAN ; Yuchi WANG ; Lihua SONG ; Peng YUAN
Chinese Journal of Oncology 2021;43(10):1114-1121
Objective:To observe the efficacy and safety of albumin-bound paclitaxel in the treatment of metastatic breast cancer.Methods:Multi-center data of patients who accepted single-drug albumin-bound paclitaxel or combination regimens from 2013 to 2019 were collected and the efficacy and safety were evaluated. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates.Results:A total of 203 advanced breast cancer cases were enrolled. The median progression-free survival time (PFS) lasted for 4 months, the median overall survival(OS)was 14 months, objective response rate (ORR) was 36.0% while the disease control rate (DCR) was 81.3%. The ORRs of Luminal, human epidermal growth factor receptor 2 (HER2) overexpression and triple-negative breast cancer patients underwent albumin-bound paclitaxel treatment were 37.3%, 45.5% and 31.0%, respectively, the DCRs were 85.5%, 68.2% and 78.9%, respectively. The OS of patients with relapse or metastasis who accepted less than two and more than two chemotherapy regimens were 22 months and 11 months ( P<0.000 1), the ORRs were 44.9% vs 30.4%, DCRs were 87.2% vs 77.6% ( P=0.018). The ORR and DCR of patients who accepted traditional paclitaxel treatment before the albumin-bound paclitaxel treatment were 35.8% and 82.1%, respectively. The common adverse reaction of these patients was numbness of limbs, which incidence rate was 64.5% (131/203), and 61.1% (124/203) were degree 1 to 2. Other adverse reactions including decreased white blood cells, which incidence rate was 56.1% (114/203); nausea and vomit, which incidence rate was 36.9% (75/203); anemia, which incidence rate was 21.2% (43/203); decreased platelet, which incidence rate was 18.7% (38/203); hepatic dysfunction, which incidence rate was 18.2% (37/203). Conclusions:Albumin-bound paclitaxel single or combination regimen is still significant efficient for various molecular subtypes of breast cancer patients or patients with traditional paclitaxel resistance or multi-line chemotherapy failure. Early usage has better prognosis, controllable adverse reaction and prominent clinical application value.
3.Mid-term analysis of prospective cohort study of rivaroxaban in preventing CRT in breast cancer
Die SANG ; Shanmin FAN ; Shiyu LI ; Jintao ZHANG ; Hengmin WANG ; Xiaohui ZHAO ; Lijun ZHENG ; Ping LIANG ; Guangbiao XI ; Longmei ZHAO ; Yurong ZHANG ; Peng YUAN
Chinese Journal of Oncology 2024;46(3):256-262
Objective:To explore the efficacy and safety of Rivaroxaban in preventing catheter related thrombosis (CRT) in patients with breast cancer who are undergoing central venous catheter chemotherapy, and provide basis for making standardized prevention and treatment strategies.Methods:In this research, a prospective cohort study was adopted, and breast cancer patients who received central venous catheter chemotherapy in Sanhuan Cancer Hospital during September 2020 to March 2022 were selected as a treatment group to take the rivaroxaban anticoagulation therapy with 10 mg.po.qd for one month. The control group got no preventive anticoagulation therapy. Vascular ultrasound examination was taken to confirm the occurrence of CRT, and a chi-square test was done for comparison the disparity between the groups. Logistic regression was applied to analyze the univariate and multivariate factors for the formation of CRT.Results:In the research, a total of 235 patients were selected, and there were a total of 19 035 days of catheterization with 81 days of catheterization on average. While in the control group, the incidence of CRT was 28.0% (33/118), the incidence of CRT in the treatment group was 20.5% (24/117), the difference was no significant ( P=0.183). Subgroup analysis results showed that the peripherally inserted central catheter (PICC) was performed in 165 cases with the CRT incidence of 18.2% (30/165) and thrombosis was mostly seen around axillary vein, accounting for 63.3%. Subclavian vein catheterization was performed in 63 cases with the CRT incidence of 39.7% (25/63), and thrombosis was mostly seen around subclavian vein, accounting for 88.0% (22/25). Implantable venous access port was implanted in 7 cases around subclavian vein and internal jugular vein with the CRT incidence of 28.6% (2/7). The patients who developed CRT within 30 days after catheterization accounted for 54.4% (31/57), 22.8% (13/57) in a period during 30 days and 60 days) and 22.8% (13/57) in a period during 60 days and 180 days). The diagnosed CRT patients had been treated with rivaroxaban 15 mg.bid.po for 3 months. During the 3 months, 100.0% of the thrombosis waned, 71.9% (41/57) of the thrombosis waned within 30 days, 19.3% (11/57) in a period during 30 and 60days and 8.8% (5/57) in a period during 60 days and 90 days. Univariate and multivariate analysis indicated that the risk of CRT in subclavian vein catheterization was higher than that in PICC, respectively ( OR=2.898, 95% CI:1.386-6.056 P=0.005), and the type of catheterization was an independent factor for the formation of thrombosis. Safety analysis result showed that in the prevention of CRT, rivaroxaban treatment did not induce drug-related bleeding, liver function damage, bone marrow suppression or any other side effects. While CRT diagnosed patients were treated with anticoagulation, they kept the central venous catheter, and the infusion was smooth. These patients all finished the anti-tumor treatment as planned, and no abnormalities like new thrombosis or pulmonary embolism were observed. Conclusions:In the mid-term analysis, the proportion of Rivaroxaban in preventing anticoagulant CRT decreases, but it don't reach statistical significance. The sample size should be further increased for observation. Rivaroxaban is proved effective and very safe in the treatment of CRT, and does not affect the concurrent chemotherapy. Medical personnel should carry out the policy of "early prevention, early detection and early treatment" for CRT so as to improve the patients' quality of life.
4.Mid-term analysis of prospective cohort study of rivaroxaban in preventing CRT in breast cancer
Die SANG ; Shanmin FAN ; Shiyu LI ; Jintao ZHANG ; Hengmin WANG ; Xiaohui ZHAO ; Lijun ZHENG ; Ping LIANG ; Guangbiao XI ; Longmei ZHAO ; Yurong ZHANG ; Peng YUAN
Chinese Journal of Oncology 2024;46(3):256-262
Objective:To explore the efficacy and safety of Rivaroxaban in preventing catheter related thrombosis (CRT) in patients with breast cancer who are undergoing central venous catheter chemotherapy, and provide basis for making standardized prevention and treatment strategies.Methods:In this research, a prospective cohort study was adopted, and breast cancer patients who received central venous catheter chemotherapy in Sanhuan Cancer Hospital during September 2020 to March 2022 were selected as a treatment group to take the rivaroxaban anticoagulation therapy with 10 mg.po.qd for one month. The control group got no preventive anticoagulation therapy. Vascular ultrasound examination was taken to confirm the occurrence of CRT, and a chi-square test was done for comparison the disparity between the groups. Logistic regression was applied to analyze the univariate and multivariate factors for the formation of CRT.Results:In the research, a total of 235 patients were selected, and there were a total of 19 035 days of catheterization with 81 days of catheterization on average. While in the control group, the incidence of CRT was 28.0% (33/118), the incidence of CRT in the treatment group was 20.5% (24/117), the difference was no significant ( P=0.183). Subgroup analysis results showed that the peripherally inserted central catheter (PICC) was performed in 165 cases with the CRT incidence of 18.2% (30/165) and thrombosis was mostly seen around axillary vein, accounting for 63.3%. Subclavian vein catheterization was performed in 63 cases with the CRT incidence of 39.7% (25/63), and thrombosis was mostly seen around subclavian vein, accounting for 88.0% (22/25). Implantable venous access port was implanted in 7 cases around subclavian vein and internal jugular vein with the CRT incidence of 28.6% (2/7). The patients who developed CRT within 30 days after catheterization accounted for 54.4% (31/57), 22.8% (13/57) in a period during 30 days and 60 days) and 22.8% (13/57) in a period during 60 days and 180 days). The diagnosed CRT patients had been treated with rivaroxaban 15 mg.bid.po for 3 months. During the 3 months, 100.0% of the thrombosis waned, 71.9% (41/57) of the thrombosis waned within 30 days, 19.3% (11/57) in a period during 30 and 60days and 8.8% (5/57) in a period during 60 days and 90 days. Univariate and multivariate analysis indicated that the risk of CRT in subclavian vein catheterization was higher than that in PICC, respectively ( OR=2.898, 95% CI:1.386-6.056 P=0.005), and the type of catheterization was an independent factor for the formation of thrombosis. Safety analysis result showed that in the prevention of CRT, rivaroxaban treatment did not induce drug-related bleeding, liver function damage, bone marrow suppression or any other side effects. While CRT diagnosed patients were treated with anticoagulation, they kept the central venous catheter, and the infusion was smooth. These patients all finished the anti-tumor treatment as planned, and no abnormalities like new thrombosis or pulmonary embolism were observed. Conclusions:In the mid-term analysis, the proportion of Rivaroxaban in preventing anticoagulant CRT decreases, but it don't reach statistical significance. The sample size should be further increased for observation. Rivaroxaban is proved effective and very safe in the treatment of CRT, and does not affect the concurrent chemotherapy. Medical personnel should carry out the policy of "early prevention, early detection and early treatment" for CRT so as to improve the patients' quality of life.