Study populations
Post-menopausal mHRPBC patients who were followed up at the medical oncology clinic, using fulvestrant were retrospectively screened. The study included patients aged 18 years and older, who developed metastasis while taking tamoxifen and/or aromatase inhibitors in the adjuvant period (adjuvant hormonal therapy used for at least 12 months) or were detected to have metastasis at the time of diagnosis. All the patients had histologically confirmed mHRPBC and used 500 mg fulvestrant (on days 0, 14, and 28, followed by every 28 days) until treatment was discontinued due to progression, toxicity, or mortality.
Overall survival (OS) times of the patients are defined as the time from the date of diagnosis to mortality or the last follow-up for the surviving patients. Progression-free survival (PFS) was determined as the time from the beginning of fulvestrant use to disease progression or mortality from any cause. PFS, OS, clinical response, adverse events, and clinical response to subsequent post-fulvestrant therapy were investigated. Body mass index (BMI) was calculated by dividing the body weight by the square of height (kg/m²). The patients were classified into two groups according to their BMI values (<30 and ≥30). The primary endpoint was PFS, and the secondary endpoint was factors affecting PFS. The Response Evaluation Criteria in Solid Tumors (RECIST) were used to evaluate clinical response. The best overall response was determined according to the following criteria: complete response (CR), stable disease (SD), partial response (PR), and progressive disease (PD). The clinical benefit rate (CBR) of the patients was calculated by summing the three response rates (CR + PR + SD), and the overall response rate (ORR) was calculated by summing the partial and complete responses.
Statistical analysis
Descriptive statistics were presented as numbers and percentages for categorical variables, and median with minimum and maximum values and mean ± standard deviation for numerical variables. Survival analysis was performed with the Kaplan-Meier method. Significant variables in the univariate analysis were introduced into a multivariate Cox model. The p-value <0.05 was considered significant in all statistical analyses.
Post-menopausal mHRPBC patients who were followed up at the medical oncology clinic, using fulvestrant were retrospectively screened. The study included patients aged 18 years and older, who developed metastasis while taking tamoxifen and/or aromatase inhibitors in the adjuvant period (adjuvant hormonal therapy used for at least 12 months) or were detected to have metastasis at the time of diagnosis. All the patients had histologically confirmed mHRPBC and used 500 mg fulvestrant (on days 0, 14, and 28, followed by every 28 days) until treatment was discontinued due to progression, toxicity, or mortality.
Overall survival (OS) times of the patients are defined as the time from the date of diagnosis to mortality or the last follow-up for the surviving patients. Progression-free survival (PFS) was determined as the time from the beginning of fulvestrant use to disease progression or mortality from any cause. PFS, OS, clinical response, adverse events, and clinical response to subsequent post-fulvestrant therapy were investigated. Body mass index (BMI) was calculated by dividing the body weight by the square of height (kg/m²). The patients were classified into two groups according to their BMI values (<30 and ≥30). The primary endpoint was PFS, and the secondary endpoint was factors affecting PFS. The Response Evaluation Criteria in Solid Tumors (RECIST) were used to evaluate clinical response. The best overall response was determined according to the following criteria: complete response (CR), stable disease (SD), partial response (PR), and progressive disease (PD). The clinical benefit rate (CBR) of the patients was calculated by summing the three response rates (CR + PR + SD), and the overall response rate (ORR) was calculated by summing the partial and complete responses.
Statistical analysis
Descriptive statistics were presented as numbers and percentages for categorical variables, and median with minimum and maximum values and mean ± standard deviation for numerical variables. Survival analysis was performed with the Kaplan-Meier method. Significant variables in the univariate analysis were introduced into a multivariate Cox model. The p-value <0.05 was considered significant in all statistical analyses.
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