Abstract：
Background and purpose: Capecitabine can be used as first-line treatment for advanced breast cancer. However, real-world data on efficacy of capecitabine in this setting is sparse. The purpose of the study is to evaluate outcomes of patients with Human Epidermal Growth Factor Receptor (HER2)-normal advanced breast cancer treated with capecitabine monotherapy as first-line treatment.
METHODS: The study utilized the Danish Breast Cancer Group (DBCG) database and was conducted retrospectively across all Danish oncology departments. Inclusion criteria were female patients, with HER2-normal advanced breast cancer treated with capecitabine monotherapy as the first-line treatment from 2010 to 2020. The primary endpoints were overall survival (OS) and progression-free survival (PFS).
RESULTS: A total of 494 patients were included. Median OS was 16.4 months (95% confidence interval [CI]: 14.5-18.0), and median PFS was 6.0 months (95% CI: 5.3-6.7). Patients with estrogen receptor (ER)-positive disease had significantly longer OS (median: 22.8 vs. 10.5 months, p < 0.001) and PFS (median: 7.4 vs. 4.9 months, p = 0.003), when compared to ER-negative patients. Stratifying by age, patients under 45 years displayed a median PFS of 4.1 months, while those aged 45-70 years and over 70 years had median PFS of 5.7 and 7.2 months, respectively (p = 0.01).
CONCLUSIONS: In this nationwide study, the efficacy of capecitabine as a first-line treatment for HER2-normal advanced breast cancer is consistent with other, mainly retrospective, studies. However, when assessed against contemporary and newer treatments, its effectiveness appears inferior to alternative chemotherapies or targeted therapies.
METHODS: The study utilized the Danish Breast Cancer Group (DBCG) database and was conducted retrospectively across all Danish oncology departments. Inclusion criteria were female patients, with HER2-normal advanced breast cancer treated with capecitabine monotherapy as the first-line treatment from 2010 to 2020. The primary endpoints were overall survival (OS) and progression-free survival (PFS).
RESULTS: A total of 494 patients were included. Median OS was 16.4 months (95% confidence interval [CI]: 14.5-18.0), and median PFS was 6.0 months (95% CI: 5.3-6.7). Patients with estrogen receptor (ER)-positive disease had significantly longer OS (median: 22.8 vs. 10.5 months, p < 0.001) and PFS (median: 7.4 vs. 4.9 months, p = 0.003), when compared to ER-negative patients. Stratifying by age, patients under 45 years displayed a median PFS of 4.1 months, while those aged 45-70 years and over 70 years had median PFS of 5.7 and 7.2 months, respectively (p = 0.01).
CONCLUSIONS: In this nationwide study, the efficacy of capecitabine as a first-line treatment for HER2-normal advanced breast cancer is consistent with other, mainly retrospective, studies. However, when assessed against contemporary and newer treatments, its effectiveness appears inferior to alternative chemotherapies or targeted therapies.
摘要：
背景与目的:卡培他滨可作为晚期乳腺癌的一线治疗药物。然而,在这种情况下，卡培他滨疗效的真实世界数据很少。该研究的目的是评估以卡培他滨单药治疗作为一线治疗的人表皮生长因子受体（HER2）正常晚期乳腺癌患者的预后。
方法：该研究利用了丹麦乳腺癌组（DBCG）数据库，并在所有丹麦肿瘤科进行了回顾性研究。纳入标准为女性患者，2010年至2020年，HER2正常晚期乳腺癌以卡培他滨单药治疗为一线治疗。主要终点是总生存期（OS）和无进展生存期（PFS）。
结果：共纳入494例患者。中位OS为16.4个月（95%置信区间[CI]：14.5-18.0），中位PFS为6.0个月（95%CI：5.3-6.7）。雌激素受体（ER）阳性疾病患者的OS明显更长（中位数：22.8vs.10.5个月，p<0.001）和PFS（中位数：7.4vs.4.9个月,p=0.003),与ER阴性患者相比。按年龄分层，45岁以下患者的中位PFS为4.1个月，而年龄在45-70岁和70岁以上的人的中位PFS为5.7和7.2个月，分别(p=0.01)。
结论：在这项全国性的研究中，卡培他滨作为HER2正常晚期乳腺癌一线治疗的疗效与其他,主要是回顾性的，研究。然而,当评估当代和更新的治疗方法时，其有效性似乎不如替代化疗或靶向治疗。
方法：该研究利用了丹麦乳腺癌组（DBCG）数据库，并在所有丹麦肿瘤科进行了回顾性研究。纳入标准为女性患者，2010年至2020年，HER2正常晚期乳腺癌以卡培他滨单药治疗为一线治疗。主要终点是总生存期（OS）和无进展生存期（PFS）。
结果：共纳入494例患者。中位OS为16.4个月（95%置信区间[CI]：14.5-18.0），中位PFS为6.0个月（95%CI：5.3-6.7）。雌激素受体（ER）阳性疾病患者的OS明显更长（中位数：22.8vs.10.5个月，p<0.001）和PFS（中位数：7.4vs.4.9个月,p=0.003),与ER阴性患者相比。按年龄分层，45岁以下患者的中位PFS为4.1个月，而年龄在45-70岁和70岁以上的人的中位PFS为5.7和7.2个月，分别(p=0.01)。
结论：在这项全国性的研究中，卡培他滨作为HER2正常晚期乳腺癌一线治疗的疗效与其他,主要是回顾性的，研究。然而,当评估当代和更新的治疗方法时，其有效性似乎不如替代化疗或靶向治疗。
