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紫杉醇和贝伐珠单抗作为一线联合治疗转移性乳腺癌患者:希腊肿瘤协作组的生物标志物评估经验。

Paclitaxel and bevacizumab as first line combined treatment in patients with metastatic breast cancer: the Hellenic Cooperative Oncology Group experience with biological marker evaluation.

机构信息

Department of Medical Oncology, "Papageorgiou" Hospital, Ring Road, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece.

出版信息

Anticancer Res. 2011 Sep;31(9):3007-18.

Abstract

BACKGROUND

Randomized studies have shown that bevacizumab combined with taxane-based regimens increases response rates and prolongs progression-free survival (PFS) of patients with metastatic breast cancer (MBC). However predictive or prognostic biological markers that identify the appropriate target population, thus improving the cost-effectiveness ratio of this treatment, are still needed.

PATIENTS AND METHODS

Retrospectively, 124 patients with MBC treated either with paclitaxel 90 mg/m² weekly x12 plus bevacizumab 10 μg/kg every 2 weeks or 15 μg/kg every 3 weeks (85 patients) or paclitaxel 175 mg/m² plus bevacizumab 15 μg/kg every 3 weeks for 6 cycles (36 patients) were identified. Additionally, the prognostic significance of a panel of key biological markers was evaluated centrally by immunohistochemistry (IHC) in 88 evaluable patients.

RESULTS

More than two thirds of the patients completed chemotherapy, as planned. The response rate was almost identical (55.3% vs. 55.6%) in the patients treated with weekly or 3-weekly paclitaxel, respectively. After a median follow-up time of 23 months, the median PFS of the study population was 13 months, while median survival had not yet been reached. Common severe adverse events were neutropenia (33%), neuropathy (18.6%) and metabolic disturbances (17.6%). The incidence of hypertension of all grades was 28.1%. High expression of vascular endothelial growth factor (VEGF) receptor 3 (VEGFR3) was associated with clinical response, while high expression of VEGFR1 was associated with poor survival.

CONCLUSION

The safety and activity of the combination of bevacizumab with paclitaxel given either weekly or 3-weekly in patients with MBC is confirmed.

摘要

背景

随机研究表明,贝伐单抗联合紫杉烷类方案可提高转移性乳腺癌(MBC)患者的缓解率并延长无进展生存期(PFS)。然而,仍需要预测或预后的生物标志物来确定合适的目标人群,从而提高这种治疗的成本效益比。

患者和方法

回顾性分析了 124 例接受每周紫杉醇 90mg/m² 联合贝伐单抗 10μg/kg 每 2 周或 15μg/kg 每 3 周(85 例)或紫杉醇 175mg/m² 联合贝伐单抗 15μg/kg 每 3 周治疗 6 个周期(36 例)治疗的 MBC 患者。此外,对 88 例可评估患者的一组关键生物标志物的预后意义进行了中心免疫组化(IHC)评估。

结果

超过三分之二的患者按计划完成了化疗。每周或每 3 周接受紫杉醇治疗的患者的缓解率几乎相同(55.3% vs. 55.6%)。中位随访时间为 23 个月时,研究人群的中位 PFS 为 13 个月,而中位生存期尚未达到。常见的严重不良事件为中性粒细胞减少症(33%)、周围神经病变(18.6%)和代谢紊乱(17.6%)。所有级别高血压的发生率为 28.1%。血管内皮生长因子受体 3(VEGFR3)高表达与临床反应相关,而 VEGFR1 高表达与生存不良相关。

结论

贝伐单抗联合紫杉醇每周或每 3 周给药在 MBC 患者中的安全性和疗效得到证实。

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