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JCO:贝伐单抗联合多西他赛及曲妥珠单抗不能改善乳腺癌患者无进展生存率

2013-04-26 JCO dxy

在2013年4月8日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上,意大利米兰San Raffaele医院的Luca Gianni发文对AVEREL临床III期试验的结果进行了报告,AVEREL [阿瓦斯汀(贝伐单抗)联合赫赛汀(曲妥珠单抗)/多西他赛治疗HER2呈阳性的转移性乳腺癌患者]临床试验主要针对人表皮生长因子受体2(HER2)呈阳性的局部复发性

在2013年4月8日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上,意大利米兰San Raffaele医院的Luca Gianni发文对AVEREL临床III期试验的结果进行了报告,AVEREL [阿瓦斯汀(贝伐单抗)联合赫赛汀(曲妥珠单抗)/多西他赛治疗HER2呈阳性的转移性乳腺癌患者]临床试验主要针对人表皮生长因子受体2(HER2)呈阳性的局部复发性/转移性乳腺癌(LR/MBC)患者,评价含贝伐单抗的一线治疗方案在此类患者中的应用情况。

AVEREL研究对象为HER2呈阳性的LR/MBC可测量/可评价患者,这些患者均未曾因LR/MBC接受过曲妥珠单抗或化疗方案治疗,根据患者所接受的前期辅助性曲妥珠单抗治疗、前期(新)辅助紫杉醇治疗、激素受体状态以及患者的病情评定结果,研究人员对参试患者进行了分层,患者在接受100 mg/m2多西他赛及负荷剂量为8 mg/kg的曲妥珠单抗联合治疗后,随机接受6 mg/kg曲妥珠单抗联合或不联合15 mg/kg的贝伐单抗治疗,每3周对所有患者进行给药。研究主要终点为无进展生存率(PFS)。其他终点包括总生存率、缓解率(RR)、安全性、生活治疗以及转化医学研究。

研究人员对治疗组424例患者间的基线特征进行了平衡。研究发现,多数患者存在内脏转移,43%的患者无病间隔期小于12个月,85%的患者病情可测。中位随访时间为26个月。根据研究人员评价,PFS风险比为0.82 (95% CI, 0.65至1.02; P = .0775; 中位PFS, 无贝伐单抗组13.7个月 v 贝伐单抗组16.5 个月; 72%的患者存在PFS事件)。根据独立评审委员会评价,PFS风险比为0.72 (95% CI, 0.54至 0.94; P = .0162; 中位 PFS分别为, 13.9个月 v 16.8 个月; 53%的患者存在PFS事件)。RR则分别为70%及74%(P = .3492)。含贝伐单抗治疗组更常见≥ 3级发热性中性粒细胞减少症及高血压。较高的血浆血管内皮生长因子A(VEGF-A)含量基线值与较大的贝伐单抗获益有关(无统计学意义上的显著性)。

最终经研究人员评价,贝伐单抗联合多西他赛及曲妥珠单抗方案并未显著改善患者PFS。此外,血浆VEGF-A的潜在预测值与在HER2呈阴性的LR/MBC患者结果一致,可据此进行前瞻性评价。
乳腺癌相关的拓展阅读:


AVEREL: A Randomized Phase III Trial Evaluating Bevacizumab in Combination With Docetaxel and Trastuzumab as First-Line Therapy for HER2-Positive Locally Recurrent/Metastatic Breast Cancer.
PURPOSE
The AVEREL trial [A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2-Positive Metastatic Breast Cancer] evaluated first-line bevacizumab-containing therapy for human epidermal growth factor receptor 2 (HER2) -positive locally recurrent/metastatic breast cancer (LR/MBC).
PATIENTS AND METHODS
Patients with measurable/evaluable HER2-positive LR/MBC who had not received trastuzumab or chemotherapy for LR/MBC were stratified by prior adjuvant trastuzumab, prior (neo)adjuvant taxane, hormone receptor status, and measurable disease and were randomly assigned to receive docetaxel 100 mg/m2 plus trastuzumab 8 mg/kg loading dose followed by 6 mg/kg either with bevacizumab 15 mg/kg or without bevacizumab, all administered every 3 weeks. The primary end point was progression-free survival (PFS). Additional end points included overall survival, response rate (RR), safety, quality of life, and translational research.
Results
Baseline characteristics of the 424 patients were balanced between treatment arms. Most patients had visceral metastases, 43% had a disease-free interval less than 12 months, and 85% had measurable disease. Median follow-up was 26 months. The hazard ratio for investigator-assessed PFS was 0.82 (95% CI, 0.65 to 1.02; P = .0775; median PFS, 13.7 v 16.5 months in the non-bevacizumab and bevacizumab arms, respectively; PFS events in 72%). The Independent Review Committee-assessed PFS hazard ratio was 0.72 (95% CI, 0.54 to 0.94; P = .0162; median PFS, 13.9 v 16.8 months, respectively; PFS events in 53%). The RR was 70% versus 74%, respectively (P = .3492). Grade ≥ 3 febrile neutropenia and hypertension were more common with bevacizumab-containing therapy. High baseline plasma vascular endothelial growth factor A (VEGF-A) concentrations were associated with greater bevacizumab benefit (not statistically significant).
CONCLUSION
Combining bevacizumab with docetaxel and trastuzumab did not significantly improve investigator-assessed PFS. The potential predictive value of plasma VEGF-A is consistent with findings in HER2-negative LR/MBC, warranting prospective evaluation.

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    2013-05-01 智慧医人
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       根据第35届圣安东尼奥乳腺癌研讨会公布的研究结果,在三阴乳腺癌的术后化疗方案中添加贝伐珠单抗并未显著改善无病生存。        3期BEATRICE试验的初步结果可能是这种进行广泛试验的乳腺癌药物走向终点的信号,一位专家如是说。        “这

Oncologist:贝伐单抗联合化疗可能提高疗效

针对肿瘤新生血管形成或血管生成的治疗手段在癌症治疗中占有重要地位,贝伐单抗等针对血管内皮生长因子(VEGF)的单克隆抗体生物制剂在临床上已被广泛运用。 抗血管生成疗法的基本原理是如果肿瘤获得新的血液供应能力有限,那么它们的生长和转移能力也会受到限制。更多的证据表明,修饰和/或“正常化”不规则的肿瘤血管,减少缺氧可加强肿瘤细胞毒性化疗(CT)的功效。 事实上,对于转移性大肠直肠癌,贝伐单抗联合C

Meta分析:阿瓦斯汀对乳腺癌患者无益

MedSci补充:本荟萃分析表明对转移性乳腺癌来说,抗VEGF治疗,仍然存在争议。对患者的PFS来说,可能是有益的,但对OS,以及QOL尚未发现益处。但是VEGF已被中止用于乳腺癌,因此,本荟萃分析的价值是相对较小的。但是,阿瓦斯汀仍广泛用于治疗其它一些肿瘤的治疗。       针对抗癌药阿瓦斯汀(贝伐单抗)一项的新研究显示,并不能延长

CTRC-AACR:多项贝伐单抗临床试验报告公布

   贝伐单抗在晚期乳腺癌的治疗中的疗效一直很有争议。在今年即将召开的圣安东尼奥乳癌研讨会(CTRC-AACR)上,将会报告两项新的临床试验研究(BEATRICE研究和LEA研究)。        BEATRICE:剑指早期三阴乳腺癌        由 贝伐单抗(阿瓦斯汀)的销售

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