Efficacy and safety of bevacizumab in combination with docetaxel for the first-line treatment of elderly patients with locally recurrent or metastatic breast cancer: results from AVADO.

摘要: Abstract Background 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 efficacy patients, defined as ⩾65 years old, AVastin And DOcetaxel (AVADO) receiving first-line bevacizumab plus docetaxel for metastatic breast cancer (mBC). Patients methods with HER2-negative, locally recurrent or mBC were randomised 3-weekly (100 mg/m2) placebo, 7.5 mg/kg 15 mg/kg, 9 cycles until disease progression unacceptable toxicity. had prior chemotherapy mBC. Results Progression-free survival (PFS) was increased the subpopulation (n = 127), effect being greater higher dose (hazard ratio = 0.63 [95% confidence interval (CI) 0.383–1.032] versus 0.76 CI: 0.46–1.262], respectively). PFS numerically similar overall populations, but former failed achieve statistical significance. Overall response rates 15 mg/kg 44.7%, 36.6% 50.0%, respectively. Effects on not statistically significant. Bevacizumab well tolerated most common adverse effects neutropenia febrile neutropenia; there excess grade ⩾ 3 cardiovascular events. There clear correlation between baseline hypertension its development during study treatment. Conclusions In this sub-analysis AVADO, showed population. unexpected signals aged 65 years older.