多西紫杉醇
贝伐单抗
医学
转移性乳腺癌
中性粒细胞减少症
内科学
危险系数
发热性中性粒细胞减少症
不利影响
肿瘤科
乳腺癌
安慰剂
人口
化疗
癌症
置信区间
外科
病理
替代医学
环境卫生
作者
Xavier Pivot,Andreas Schneeweiß,Shailendra Verma,Christoph Thomssen,José Luís Passos‐Coelho,Giovanni Benedetti,Eva Ciruelos,Roger von Moos,Hong‐Tai Chang,Anja-Alexandra Duenne,David Miles
标识
DOI:10.1016/j.ejca.2011.06.018
摘要
Oncologic treatment in elderly patients is challenging, due to comorbidities, often impaired organ function, limited clinical trial evidence, inadequate guidelines and no consistent 'elderly' definition. We report exploratory sub-analyses of safety and efficacy in elderly patients, defined as ⩾ 65years old, in AVastin And DOcetaxel (AVADO) receiving first-line bevacizumab plus docetaxel for metastatic breast cancer (mBC).Patients with HER2-negative, locally recurrent or mBC were randomised to 3-weekly docetaxel (100mg/m(2)) with placebo, bevacizumab 7.5mg/kg or bevacizumab 15 mg/kg, for 9 cycles or until disease progression or unacceptable toxicity. Patients had no prior chemotherapy for mBC.Progression-free survival (PFS) was increased with bevacizumab in the elderly subpopulation (n=127), the effect being greater with higher dose (hazard ratio=0.63 [95% confidence interval (CI) 0.383-1.032] versus 0.76 [95% CI: 0.46-1.262], respectively). PFS was numerically similar in the elderly and overall populations, but the former failed to achieve statistical significance. Overall response rates for docetaxel plus placebo, bevacizumab 7.5mg/kg and 15 mg/kg were 44.7%, 36.6% and 50.0%, respectively. Effects on survival were not statistically significant. Bevacizumab was well tolerated in elderly patients, the most common adverse effects were neutropenia and febrile neutropenia; there was no excess of grade⩾3 cardiovascular events. There was no clear correlation between baseline hypertension and its development during study treatment.In this exploratory sub-analysis in AVADO, bevacizumab plus docetaxel showed efficacy in elderly patients similar to the overall study population. There were no unexpected safety signals in patients aged 65 years or older.
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