Search

Background Two global phase 3 trials (301 trial of first- or second-line eribulin, EMBRACE of third- or later-line eribulin) were carried out during development of eribulin for breast cancer treatment. In this post marketing observation study in Japan, efficacy and safety of eribulin in metastatic breast cancer patients were examined. Additionally, the results were compared with that of phase 3 trials. Method We conducted a prospective study in patients with inoperable or recurrent HER2-negative breast cancer. We enrolled a similar number of patients receiving eribulin as first- or second-line therapy (early line) and those receiving eribulin as third- or later line therapy (later line), and followed the patients for two years (ClinicalTrials.gov Number: NCT02371174). For the overall survival and time to treatment failure, the estimated value of them were calculated by the Kaplan Meier method. The severity of adverse drug events was determined by CTCAE v 4.0. Results During September 2014 to February 2016, 651cases were registered at 182 facilities. In analysis set, 637 patients (319 patients of early line/317 patients of late line/1 patient of unknown) was median age of 62.7 (30 - 85) years. Performance status 0/1/2/3/4 was seen in 360/234/38/5/0 patients, respectively. Dose reduction were required in 33% of patients. The median overall survival (early line/late line) was 18.8 months/12.6 months, respectively, and median time to treatment failure was 4.4 months/3.8 months, respectively. Major side effects (early line/late line) were neutropenia (51%/56%), leucopenia (55%/57%), peripheral neuropathy (32%/22%). Grade 3≤ peripheral neuropathy was 2%. Conclusion The results of overall survival (18.8 months in early line, 12.6 months in later line) in this study is comparable to those of large phase 3 study (15.9 months in 301 trial, 13.1 months in EMBRACE). The incidence of Grade 3≤ peripheral neuropathy was lower than that of phase 3 trials. [ABSTRACT FROM AUTHOR]

Two global phase 3 trials (301 trial of first- or second-line eribulin, EMBRACE of third- or later-line eribulin) were carried out during development of eribulin for breast cancer treatment. In this post marketing observation study in Japan, efficacy and safety of eribulin in metastatic breast cancer patients were examined. Additionally, the results were compared with that of phase 3 trials. We conducted a prospective study in patients with inoperable or recurrent HER2-negative breast cancer. We enrolled a similar number of patients receiving eribulin as first- or second-line therapy (early line) and those receiving eribulin as third- or later line therapy (later line), and followed the patients for two years (ClinicalTrials.gov Number: NCT02371174). For the overall survival and time to treatment failure, the estimated value of them were calculated by the Kaplan Meier method. The severity of adverse drug events was determined by CTCAE v 4.0. During September 2014 to February 2016, 651cases were registered at 182 facilities. In analysis set, 637 patients (319 patients of early line/317 patients of late line/1 patient of unknown) was median age of 62.7 (30 - 85) years. Performance status 0/1/2/3/4 was seen in 360/234/38/5/0 patients, respectively. Dose reduction were required in 33% of patients. The median overall survival (early line/late line) was 18.8 months/12.6 months, respectively, and median time to treatment failure was 4.4 months/3.8 months, respectively. Major side effects (early line/late line) were neutropenia (51%/56%), leucopenia (55%/57%), peripheral neuropathy (32%/22%). Grade 3≤ peripheral neuropathy was 2%. The results of overall survival (18.8 months in early line, 12.6 months in later line) in this study is comparable to those of large phase 3 study (15.9 months in 301 trial, 13.1 months in EMBRACE). The incidence of Grade 3≤ peripheral neuropathy was lower than that of phase 3 trials. [ABSTRACT FROM AUTHOR]

While pertuzumab was added to adjuvant therapy for high-risk HER2-positive breast cancer according to APHINY trial, definition of "high risk of recurrence" is still unclear. Because neoadjuvant chemotherapy (NAC) including anti-HER2 drugs showed potent efficacy to achieve pCR and better survival, one lymph node metastases may show survival outcomes equivalent to node-negative cases. Hence, we examined the risk factors of recurrence in HER2-positive breast cancer and determined whether one lymph node metastasis after NAC is true predictor of recurrence. From May 1993 to March 2017, patients who underwent radical mastectomy/partial mastectomy after NAC for breast cancer in our institution were retrospectively examined. Among those patients, HER2-positive patients were 253, 23% of all patients. Breast cancer recurrence occurred in 46 (18.2%) of HER2-positive patients who underwent NAC and radical mastectomy. Multivariate analysis was performed on tumor size, lymph node metastasis, hormone receptor, Ki-67, preoperative chemotherapy regimen for recurrence risk factor. The risk of recurrence was significantly higher in one lymph node metastasis group than in the node-negative group (HR 6.157, p=.0006, 95%CI 2.175-17.435). Likewise, the risk of recurrence was significantly higher in the group with two or more lymph node metastases than in the node-negative group (HR 3.877, p=.0107, 95%CI 1.370-10.972). The presence of even one lymph node metastasis was suggested as a risk factor of recurrence, likely representing metastatic potential of the disease. [ABSTRACT FROM AUTHOR]

Background Eribulin demonstrated longer overall survival for pretreated metastatic breast cancer. Several factors are reported to be associated with their survival outcomes of breast cancer patients, and scarce of predictors are determined for each agent. Previous reports have demonstrated that high neutrophil to lymphocyte ratio (NLR) is related to poor survival outcomes of cancer. We hypothesized that low NLR is predictor of longer survival of breast cancer patients. We investigated whether baseline NLR before chemotherapy is associated with overall survival, and explored possible mechanism of better survival in patients with metastatic breast cancer. Methods We extracted female patients with metastatic breast cancer who received Eribulin for metastatic disease at NCCHE. We included HER2-negative disease, and those treated with standard chemotherapy including eribulin. We retrieved patient and disease characteristics; age, disease location, de novo stage IV or recurrent disease, hormone receptor status. Result We identified 135 patients between July 2012 and December 2018 with a median age of 57.9 (34-77), of which 106 (78.5%) had HR positive disease, 104 (77.0%) had recurrent disease, and 114 (84.4%) had visceral disease. Log rank test showed hormone receptor status and visceral disease were significant variable for candidate for multivariate analysis. COX regression model demonstrated that decreasing of NLR was associated with better OS [HR = 1.145, 95% confidence interval (95% CI)=1.073-1.223]. We showed low NLR at the administration of eribulin was independent predictor of OS [HR = 1.048, 95% confidence interval (95% CI)=1.004-1.093]. Conclusion We showed low NLR is better prognostic factor of any chemotherapy for metastatic breast cancer. Our exploratory research also showed low NLR at eribulin administraton was suspected to be better OS indicator regardless of pretreated chemotherapy. [ABSTRACT FROM AUTHOR]

While pertuzumab was added to adjuvant therapy for high-risk HER2-positive breast cancer according to APHINY trial, definition of "high risk of recurrence" is still unclear. Because neoadjuvant chemotherapy (NAC) including anti-HER2 drugs showed potent efficacy to achieve pCR and better survival, one lymph node metastases may show survival outcomes equivalent to node-negative cases. Hence, we examined the risk factors of recurrence in HER2-positive breast cancer and determined whether one lymph node metastasis after NAC is true predictor of recurrence. From May 1993 to March 2017, patients who underwent radical mastectomy/partial mastectomy after NAC for breast cancer in our institution were retrospectively examined. Among those patients, HER2-positive patients were 253, 23% of all patients. Breast cancer recurrence occurred in 46 (18.2%) of HER2-positive patients who underwent NAC and radical mastectomy. Multivariate analysis was performed on tumor size, lymph node metastasis, hormone receptor, Ki-67, preoperative chemotherapy regimen for recurrence risk factor. The risk of recurrence was significantly higher in one lymph node metastasis group than in the node-negative group (HR 6.157, p=.0006, 95%CI 2.175-17.435). Likewise, the risk of recurrence was significantly higher in the group with two or more lymph node metastases than in the node-negative group (HR 3.877, p=.0107, 95%CI 1.370-10.972). The presence of even one lymph node metastasis was suggested as a risk factor of recurrence, likely representing metastatic potential of the disease. [ABSTRACT FROM AUTHOR]