Adding bevacizumab to neoadjuvant and adjuvant chemotherapy did not provide clinical benefit to patients with non-metastatic, human epidermal growth factor receptor 2 (HER2)-negative inflammatory breast cancer, a study published in the journal The Lancet Oncology has shown.1

Previous studies have demonstrated that the addition of bevacizumab immunotherapy to standard neoadjuvant chemotherapy improves progression-free survival and pathological complete response rate in patients with HER2-negative metastatic breast cancer; however, it is unclear whether adding bevacizumab to chemotherapy improves outcomes of patients with inflammatory breast cancer.

Therefore, researchers conducted a multicenter, single-arm, phase 2 trial to evaluate the addition of bevacizumab to neoadjuvant and adjuvant chemotherapy in the treatment of patients with HER2-negative non-metastatic inflammatory breast cancer.

For the study, researchers enrolled 100 patients who all received neoadjuvant intravenous fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2, and bevacizumab 15 mg/kg every 3 weeks during cycles 1-4. Patients then received docetaxel 100 mg/m2 and bevacizumab 15 mg/kg during cycles 5-8. Two to 4 weeks after surgery, patients underwent adjuvant radiotherapy, adjuvant bevacizumab, and hormone therapy (if they had a hormone receptor-positive tumor).

Results showed that only 19% (95% CI, 12 – 28) of the 100 patients achieved a pathological complete response after neoadjuvant therapy (P = .16).

In terms of safety, the most frequently reported grade 3-4 treatment-related adverse events during the neoadjuvant phase were neutropenia (89%), febrile neutropenia (37%), and mucositis (23%). During the adjuvant phase, the most common was proteinuria (7% of 75 patients).

Of note, 48% of patients experienced a serious adverse event and 1 patient died of thrombotic microangiopathy due to bevacizumab treatment.

RELATED: Acupuncture With Enhanced Self-care Improves Quality of Life, Reduces Hot Flashes in Breast Cancer

“Longer follow-up and correlative studies to identify patients who might benefit from bevacizumab are needed,” the authors concluded.

Reference

  1. Bertucci F, Fekih M, Autret A, et al. Bevacizumab plus neoadjuvant chemotherapy in patients with HER2-negative inflammatory breast cancer (BEVERLY-1): a multicentre, single-arm, phase 2 study [published online ahead of print March 28, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)00011-5.