Background: This SafeHer subgroup analysis assessed the safety of fixed-dose subcutaneous trastuzumab (H SC) as an adjuvant therapy in HER2-positive early breast cancer (EBC) by body weight.
Patients and methods: Patients with HER2-positive EBC not previously treated with anti-HER2 therapy received H SC 600 mg (every 3 weeks for 18 cycles), with neoadjuvant or adjuvant chemotherapy or without adjuvant chemotherapy. Adverse events (AEs) were assessed throughout treatment and at final follow-up (28 ±5 days after last treatment). Subgroups were categorized by body weight, Asian origin, and chemotherapy administration. All analyses were descriptive.
Results: Of 2,577 patients enrolled, 2,573 received ≥1 dose of study medication and were included in this safety analysis. Median body weight at baseline was 67.0 kg (range 33.6-150.0 kg). Any-grade AEs occurred in 88.7% (2,282/2,573) of the overall population, versus 87.1% (590/677) of the lowest bodyweight quartile (≤59 kg), 90.0% (561/623) of the highest quartile (>77 kg), and 86.5% (327/378) of the Asian population. Grade ≥3 AEs occurred in 23.2% (596/2,573) of the overall population, 17.9% (121/677) of the lowest bodyweight quartile, 26.8% (167/623) of the highest quartile, and 15.3% (58/378) of the Asian population. The highest bodyweight quartile had the highest incidence of medical conditions at baseline (highest quartile, 75.6%; lowest quartile, 56.1%).
Conclusion: These data support the use of fixed-dose H SC as an adjuvant therapy in HER2-positive EBC and confirm the comparable safety profile of H SC in patients with low body weight or of Asian origin versus the overall population in SafeHer. ClinicalTrials.gov: NCT01566721.
Implications for practice: The safety profile of fixed-dose subcutaneous trastuzumab (H SC) was comparable between patients in the lowest bodyweight subgroup and the overall patient population, and also between patients of Asian origin (of whom a higher proportion often fall within the lower bodyweight quartiles) and the overall population. The safety data from this SafeHer subgroup analysis therefore support the use of fixed-dose H SC 600 mg administered every 3 weeks as an adjuvant therapy for patients with HER2-positive early breast cancer across different bodyweight subgroups and in the Asian patient population.
摘要
背景。此项SafeHer亚组分析主要按体重评估固定剂量皮下注射曲妥珠单抗(H SC)在HER2 阳性早期乳腺癌(EBC) 辅助治疗中的安全性。
患者和方法。先前未曾接受抗HER2治疗的HER2阳性早期乳腺癌患者接受了H SC给药(每3周一次,共18个周期),同时结合新辅助或辅助化疗或不结合辅助化疗。在整个治疗期间及末次随访(最后一次治疗后28±5天)时,对不良反应事件(AE)进行了评估。亚组按体重、亚洲血统及化疗给药方案进行分类。所有分析均为描述性分析。
结果。在2 577 名入组患者中,有2 573名患者接受了不少于1剂的研究药物,并被纳入到此项安全性分析中。基线中位体重是67.0kg(范围为33.6–150.0kg)。在所有患者中,任何级别AE发生率为 88.7% (2 282/2 573),而在体重最低的四分位组(≤59 kg)中的发生率为 87.1% (590/677),在体重最高的四分位组(高于77kg)中的发生率为90.0% (561/623),在亚洲患者人群中的发生率为86.5% (327/378)。在所有患者人群中,≥3 级AE的发生率为23.2% (596/2 573),在体重最低的四分位组中的发生率为17.9% (121/677),在体重最高的四分位组中的发生率为26.8% (167/623),在亚洲患者人群中的发生率为15.3% (58/378)。在基线,体重最高的四分位组医疗疾病发生率最高(最高四分位组为 75.6%;最低四分位组为 56.1%)。
结论。上述数据支持使用固定剂量的H SC辅助治疗HER2 阳性早期乳腺癌,并确认低体重或亚洲血统患者与参与 SafeHer 研究的所有患者群体接受H SC的安全谱相似。
实践意义
在实施皮下注射固定剂量的曲妥珠单抗(H SC) 后,最低体重亚组与所有患者群体所呈现的药物安全性相似;同样地,亚洲血统(通常低体重四分位组患者所占比例较高)患者与所有患者群体所呈现的药物安全性也很相似。因此,来自此 SafeHer 亚组分析的安全性数据支持使用固定剂量的H SC(600 mg,每 3 周一次)作为 HER2 阳性早期乳腺癌患者(涵盖不同体重的亚组和亚洲患者群体)的辅助治疗。
Keywords: Asian population; Body weight; Breast cancer; Human epidermal growth factor receptor 2‐positive; Subcutaneous injections; Trastuzumab.
© AlphaMed Press 2018.