节拍性长春瑞滨联合贝伐单抗作为转移性乳腺癌患者的挽救治疗方案
Metronomic vinorelbine plus bevacizumab as salvage therapy for patients with metastatic breast cancer.
作者信息
Saloustros E, Kalbakis K, Vardakis N, Kalykaki A, Milaki G, Rovithi M, Agelaki S, Saridaki Z, Georgoulias V, Mavroudis D
机构信息
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece.
出版信息
J BUON. 2011 Apr-Jun;16(2):215-8.
PURPOSE
Continuous administration of oral vinorelbine, given 3 times a week (metronomic), is feasible and exceptionally well tolerated at doses up to 50 mg with clinical activity against refractory tumors. In this phase II study oral metronomic vinorelbine and bevacizumab were evaluated as salvage therapy in women with pretreated metastatic breast cancer (MBC).
METHODS
Patients received oral vinorelbine (50 mg 3 times a week) and bevacizumab (10 mg/kg) biweekly in cycles of 28 days. The primary endpoint was objective response rate (ORR). A preplanned analysis was performed when the first 13 patients were evaluated for tumor response.
RESULTS
One patient (7.7%) achieved partial response (PR) and 6 (46.1%) stable disease (SD). The combination was very well tolerated but, as per protocol, the study was closed prematurely due to lack of efficacy.
CONCLUSION
The combination of oral metronomic vinorelbine and bevacizumab has good tolerance but minimal activity in terms of objective responses in pretreated patients with MBC.
目的
连续口服长春瑞滨，每周给药3次（节拍式给药），在剂量高达50mg时是可行的，且耐受性极佳，对难治性肿瘤具有临床活性。在这项II期研究中，评估了口服节拍式长春瑞滨和贝伐单抗作为预处理转移性乳腺癌（MBC）女性患者的挽救治疗方案。
方法
患者接受口服长春瑞滨（每周3次，每次50mg）和贝伐单抗（10mg/kg），每2周为一个周期，共28天。主要终点是客观缓解率（ORR）。当对首批13例患者进行肿瘤反应评估时进行了预先计划的分析。
结果
1例患者（7.7%）达到部分缓解（PR），6例（46.1%）疾病稳定（SD）。该联合方案耐受性良好，但根据方案，由于缺乏疗效，研究提前终止。
结论
口服节拍式长春瑞滨和贝伐单抗联合方案耐受性良好，但对预处理的MBC患者而言，客观反应方面活性极小。
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