title: Dose-dense doxorubicin and cyclophosphamide followed by dose-dense albumin-bound paclitaxel plus bevacizumab is safe as adjuvant therapy in patients with early stage breast cancer.
abstract: Every-2-week (dose-dense) adjuvant doxorubicin (A) plus cyclophosphamide (C) followed by cremophor-formulated paclitaxel (cf-P) was efficacious in metastatic breast cancer (BC). Albumin-bound paclitaxel (ab-P) was safe and more effective than cf-P, and the addition of bevacizumab to cf-P improved efficacy. This study compared the safety of dose-dense ab-P vs cf-P plus bevacizumab following dose-dense adjuvant AC for early-stage BC.
  
  
  METHODS
  Women with operable, histologically confirmed BC were randomized to 4 cycles of dose-dense A 60 mg/m(2) plus C 600 mg/m(2) IV with SC pegfilgrastim, followed by 4 cycles of either dose-dense IV ab-P 260 mg/m(2) or cf-P 175 mg/m(2). Bevacizumab was given during and following chemotherapy. 97 and 96% of patients completed 4 cycles of AC therapy, while 84 and 85% of patients completed 4 cycles of taxane therapy in the ab-P and cf-P arms, respectively (N = 197). Baseline patient characteristics were similar. The most common grade ≥3 taxane-related adverse events (AEs) were fatigue and neutropenia. Dose reductions were similar between the treatment arms. During AC therapy, the majority of dose reductions were due to febrile neutropenia; during taxane therapy, the majority of cases were due to neuropathy. No taxane-related dose interruption occurred in the ab-P arm, while 3 occurred in the cf-P arm due to hypersensitivity reactions. The mean cumulative paclitaxel dose was 950.5 and 660.8 mg/m(2) in the ab-P and cf-P arms, respectively. A 44% higher paclitaxel dose was delivered in the ab-P compared with the cf-P arm (P < 0.0001), while achieving a similar safety profile. ab-P plus bevacizumab following AC therapy without prophylactic premedications was tolerable in early-stage BC patients.
authors: US Oncology Research, 3535 Worth St, Dallas, 75246, TX, USA. john.pippen@usoncology.com.|Texas Oncology, Dallas, TX, USA. john.pippen@usoncology.com.|Baylor Sammons Cancer Center, Dallas, TX, USA. john.pippen@usoncology.com.
authors: John
authors: J
authors: Pippen
authors: US Oncology Research, Rocky Mountain Cancer Center, Denver, CO, USA.
authors: Devchand
authors: D
authors: Paul
authors: US Oncology Research, 3535 Worth St, Dallas, 75246, TX, USA.
authors: Svetislava
authors: S
authors: Vukelja
authors: Celgene, Summit, NJ, USA.
authors: Alicia
authors: A
authors: Clawson
authors: Celgene, Summit, NJ, USA.
authors: Jose
authors: J
authors: Iglesias
mesh_terms: D000328:Adult; D000368:Aged; D000068196:Albumin-Bound Paclitaxel / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000068196:Albumin-Bound Paclitaxel; D000068258:Bevacizumab; D004317:Doxorubicin; D003520:Cyclophosphamide