RESUMO
BACKGROUND: Several phase-III studies have shown improvements in terms of progression-free survival (PFS) with bevacizumab when added to chemotherapy in advanced breast cancer. However, the extent of improvement varied and none of the trials showed benefit in terms of overall survival (OS). PATIENTS AND METHODS: All patients with metastatic breast cancer treated with bevacizumab at our Institution between 2005 and 2011 were retrospectively analyzed. A control group was matched according to the following variables: receptor status, treatment line, type of chemotherapy, presence of visceral disease and age. RESULTS: All 212 patients were evaluable for toxicity, and 198 for response; 430 controls allowed a complete matching for 85 bevacizumab-treated patients. The addition of bevacizumab to chemotherapy significantly prolonged PFS (9.3 vs. 7.6 months, hazard ratio [HR]=0.70, 95% confidence interval [CI]=0.51-0.97, p=0.031) and OS (28.9 vs. 22.6 months, HR=0.67, 95% CI=0.45-0.99, p=0.043). Clinical benefit rate (overall response rate + stable disease for at least six months) was significantly better in the bevacizumab group (75% vs. 59%, p=0.002), while ORR did not differ significantly (48% vs. 35%, p=0.21). Patients developing hypertension during treatment had a more favourable outcome (PFS 13.7 vs. 6.6 months, HR=0.34, 95% CI=0.23-0.49 p<0.001; 2-year OS 78% vs. 30%, HR=0.20, 95% CI=0.12-0.35, p<0.001). CONCLUSION: Bevacizumab in addition to chemotherapy prolonged PFS and OS in a non-selected, partly intensively pre-treated breast cancer population. Hypertension induced by bevacizumab predicted therapy efficacy.
Assuntos
Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Biomarcadores Tumorais/análise , Neoplasias da Mama/tratamento farmacológico , Hipertensão/diagnóstico , Recidiva Local de Neoplasia/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Bevacizumab , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Estudos de Casos e Controles , Feminino , Seguimentos , Humanos , Hipertensão/induzido quimicamente , Metástase Linfática , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/mortalidade , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Prognóstico , Receptor ErbB-2/metabolismo , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
BACKGROUND: This retrospective analysis was planned as a direct comparison of taxanes plus trastuzumab to the less toxic combination of oral vinorelbine (OV) plus trastuzumab as a first-line therapy for metastatic HER2-positive breast cancer. PATIENTS AND METHODS: Patients (n = 76) receiving either taxanes (group A) or OV (group B) in combination with trastuzumab were identified from a breast cancer database. Progression-free survival (PFS) was defined as the primary study endpoint; secondary endpoints were overall survival (OS), response rate (RR), incidence of brain metastases, and brain metastases-free survival (BMFS). RESULTS: 36 patients received taxanes and 40 patients OV in combination with trastuzumab. At a median follow-up of 47.5 months, median PFS was 7 months (group A) and 9 months in group B (log-rank; non-significant), respective numbers for OS were 49 and 59 months (p = 0.033). The incidence of brain metastases did not differ significantly between the 2 treatment groups, whereas BMFS was significantly longer in patients receiving OV. CONCLUSIONS: OV plus trastuzumab yielded similar results in terms of PFS and RR and was superior in terms of OS and BMFS. These results add to the growing body of evidence that vinorelbine is a viable alternative to taxanes in HER2-positive metastatic breast cancer.