Klinik und Poliklinik für Gynäkologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Paracelsus-Klinik Osnabrück, Osnabrück, Germany.
Breast. 2021 Dec;60:70-77. doi: 10.1016/j.breast.2021.08.014. Epub 2021 Aug 27.
The multicentre non-interventional AVANTI study assessed safety, effectiveness and patient-reported outcomes with approved first-line bevacizumab-containing regimens for HER2-negative locally recurrent/metastatic breast cancer (LR/MBC) in German routine oncology practice.
Eligible patients had HER2-negative LR/MBC, no bevacizumab contraindications and no prior chemotherapy for LR/MBC. Chemotherapy schedule, diagnostics and follow-up were at physicians' discretion. Data were collected for 1 year after starting bevacizumab, then every 6 months for 1.5 years (maximum follow-up: 2.5 years). Patients and physicians rated treatment satisfaction. Subgroup analyses were prespecified in clinically relevant populations, including triple-negative breast cancer (TNBC).
Between November 1, 2009 and April 30, 2016, 2065 eligible patients at 346 centres received bevacizumab with paclitaxel or capecitabine. Patients receiving bevacizumab-capecitabine were less likely to have de novo disease and more likely to have TNBC, age ≥60 years and prior anthracycline/taxane and/or endocrine therapy. Median PFS was 12.6 (95% CI 11.9-13.2) months (12.8 with bevacizumab-paclitaxel, 10.5 with bevacizumab-capecitabine); median OS was 23.9 (95% CI 22.2-25.1) months. Outcomes were worse in patients with TNBC, prior anthracycline/taxane or prior endocrine therapy. Grade ≥3 adverse events occurred in 27% of patients. Treatment was discontinued for adverse events in 15%. Treatment satisfaction was rated as good or better by 304/394 responding patients (77%) at week 54 and in 1393/2065 patients (67%) by physicians overall.
In routine clinical practice, effectiveness and safety of first-line bevacizumab-containing therapy for LR/MBC were consistent with experience from phase III trials. Patient and physician treatment satisfaction showed high concordance.
多中心、非干预性 AVANTI 研究评估了在德国常规肿瘤学实践中，批准的贝伐珠单抗联合一线治疗方案在治疗 HER2 阴性局部复发性/转移性乳腺癌（LR/MBC）中的安全性、有效性和患者报告的结局。
符合条件的患者患有 HER2 阴性 LR/MBC，无贝伐珠单抗禁忌证，且无 LR/MBC 的既往化疗史。化疗方案、诊断和随访由医生自行决定。在开始使用贝伐珠单抗后 1 年内收集数据，然后每 6 个月收集 1.5 年（最长随访时间：2.5 年）。患者和医生评估治疗满意度。在包括三阴性乳腺癌（TNBC）在内的临床相关人群中，预先指定了亚组分析。
2009 年 11 月 1 日至 2016 年 4 月 30 日，346 个中心的 2065 名符合条件的患者接受了紫杉醇或卡培他滨联合贝伐珠单抗治疗。接受贝伐珠单抗-卡培他滨治疗的患者新发疾病的可能性较低，且更有可能患有 TNBC、年龄≥60 岁、既往使用蒽环类药物/紫杉类药物和/或内分泌治疗。中位无进展生存期（PFS）为 12.6（95%CI 11.9-13.2）个月（贝伐珠单抗-紫杉醇组为 12.8 个月，贝伐珠单抗-卡培他滨组为 10.5 个月）；中位总生存期（OS）为 23.9（95%CI 22.2-25.1）个月。在 TNBC、既往蒽环类药物/紫杉类药物或既往内分泌治疗的患者中，结局更差。27%的患者发生了≥3 级不良事件。15%的患者因不良事件停止治疗。在第 54 周时，304/394 名应答患者（77%）和 1393/2065 名患者（67%）的医生总体上对治疗的满意度评为良好或更好。
在常规临床实践中，一线贝伐珠单抗联合治疗 LR/MBC 的疗效和安全性与 III 期试验的经验一致。患者和医生对治疗的满意度高度一致。
