Cancer biology & therapy · 2026
Efficacy and safety profiles of CDK4/6 inhibitor in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) from the high-altitude versus low-altitude regions: a multi-center retrospective study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Tan Yujing, Ye Yinyin, Zhao Weihong, Jiang Hangfang, Wang Jiani, Zhao Jiuda, Ma Fei
Аннотация
BACKGROUND: CDK4/6 inhibitors (CDK4/6i) represent the standard treatment for HR+/HER2- ABC. The study assessed the efficacy and safety profiles of CDK4/6i from first-line (1 L) to third-line (3 L) in patients with HR+/HER2- ABC from high-altitude versus low-altitude regions.
MATERIALS: HR+/HER2- ABC patients who received CDK4/6i were enrolled from four cancer centers in China.
RESULTS: A total of 350 patients were eligible for the study, involving 268 from the low-altitude group and 82 from the high-altitude group. In the 1 L, objective response rate (ORR, 23.7% versus 5.3%, p = 0.01), clinical benefit rate (CBR, 88.1% versus 57.9%, p < 0.0001), and median progression-free survival (PFS, 42.1 months versus 15.2 months, p = 0.001) in the low-altitude group were superior to those in the high-altitude group. In the second-line treatment, CBR in the low-altitude group was higher (87.5% versus 48.0%, p = 5.3E-4). The ORR (20.8% versus 4.0%, p = 0.08) and PFS (15.8 months versus 8.2 months, p = 0.11) were not significantly different. In the 3 L settings, no significance was observed in PFS (5.2 months versus 5.8 months, p = 0.45), ORR (16.5% versus 21.1%, p = 0.74), and CBR (47.1% versus 47.4%, p = 1). The incidence of anemia (43.9% versus 28.3%, p = 0.01), ≥grade 3 anemia (9.8% versus 1.9%, p = 3.10E-03), ≥grade 3 thrombocytopenia (9.8% versus 1.9%, p = 3.10E-03), ≥grade 3 ALT (6.1% versus 0.4%, p = 3.10E-03) and AST (7.3% versus 1.9%, p = 0.02) dysfunction occurred more frequently in the high-altitude group.
CONCLUSION: Patients with HR+/HER2- ABC in the high-altitude region experienced inferior survival outcomes and individualized tolerability to CDK4/6i, which may inform scientific research and the management of CDK4/6i in Chinese patients with HR+/HER2- ABC.
MATERIALS: HR+/HER2- ABC patients who received CDK4/6i were enrolled from four cancer centers in China.
RESULTS: A total of 350 patients were eligible for the study, involving 268 from the low-altitude group and 82 from the high-altitude group. In the 1 L, objective response rate (ORR, 23.7% versus 5.3%, p = 0.01), clinical benefit rate (CBR, 88.1% versus 57.9%, p < 0.0001), and median progression-free survival (PFS, 42.1 months versus 15.2 months, p = 0.001) in the low-altitude group were superior to those in the high-altitude group. In the second-line treatment, CBR in the low-altitude group was higher (87.5% versus 48.0%, p = 5.3E-4). The ORR (20.8% versus 4.0%, p = 0.08) and PFS (15.8 months versus 8.2 months, p = 0.11) were not significantly different. In the 3 L settings, no significance was observed in PFS (5.2 months versus 5.8 months, p = 0.45), ORR (16.5% versus 21.1%, p = 0.74), and CBR (47.1% versus 47.4%, p = 1). The incidence of anemia (43.9% versus 28.3%, p = 0.01), ≥grade 3 anemia (9.8% versus 1.9%, p = 3.10E-03), ≥grade 3 thrombocytopenia (9.8% versus 1.9%, p = 3.10E-03), ≥grade 3 ALT (6.1% versus 0.4%, p = 3.10E-03) and AST (7.3% versus 1.9%, p = 0.02) dysfunction occurred more frequently in the high-altitude group.
CONCLUSION: Patients with HR+/HER2- ABC in the high-altitude region experienced inferior survival outcomes and individualized tolerability to CDK4/6i, which may inform scientific research and the management of CDK4/6i in Chinese patients with HR+/HER2- ABC.