PMID- 21976055 OWN - NLM STAT- MEDLINE DCOM- 20160915 LR - 20160324 IS - 1573-7217 (Electronic) IS - 0167-6806 (Linking) VI - 130 IP - 3 DP - 2011 Dec TI - 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. PG - 825-31 LID - 10.1007/s10549-011-1678-9 [doi] AB - 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. PATIENTS AND 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. FAU - Pippen, John AU - Pippen J AD - US Oncology Research, 3535 Worth St, Dallas, 75246, TX, USA. john.pippen@usoncology.com. AD - Texas Oncology, Dallas, TX, USA. john.pippen@usoncology.com. AD - Baylor Sammons Cancer Center, Dallas, TX, USA. john.pippen@usoncology.com. FAU - Paul, Devchand AU - Paul D AD - US Oncology Research, Rocky Mountain Cancer Center, Denver, CO, USA. FAU - Vukelja, Svetislava AU - Vukelja S AD - US Oncology Research, 3535 Worth St, Dallas, 75246, TX, USA. FAU - Clawson, Alicia AU - Clawson A AD - Celgene, Summit, NJ, USA. FAU - Iglesias, Jose AU - Iglesias J AD - Celgene, Summit, NJ, USA. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20111006 PL - Netherlands TA - Breast Cancer Res Treat JT - Breast cancer research and treatment JID - 8111104 RN - 0 (Albumin-Bound Paclitaxel) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) SB - IM MH - Adult MH - Aged MH - Albumin-Bound Paclitaxel/administration & dosage MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Bevacizumab/administration & dosage MH - Breast Neoplasms/*drug therapy/metabolism/*pathology MH - Chemotherapy, Adjuvant MH - Cyclophosphamide/administration & dosage MH - Doxorubicin/administration & dosage MH - Drug Administration Schedule MH - Female MH - Humans MH - Middle Aged MH - Neoplasm Staging MH - Risk Factors MH - Treatment Outcome OTO - NOTNLM OT - AC therapy OT - Albumin-bound paclitaxel OT - Bevacizumab OT - Dose-dense OT - Early stage breast cancer EDAT- 2011/10/07 06:00 MHDA- 2016/09/16 06:00 CRDT- 2011/10/07 06:00 PHST- 2011/06/28 00:00 [received] PHST- 2011/07/07 00:00 [accepted] PHST- 2011/10/07 06:00 [entrez] PHST- 2011/10/07 06:00 [pubmed] PHST- 2016/09/16 06:00 [medline] AID - 10.1007/s10549-011-1678-9 [pii] AID - 10.1007/s10549-011-1678-9 [doi] PST - ppublish SO - Breast Cancer Res Treat. 2011 Dec;130(3):825-31. doi: 10.1007/s10549-011-1678-9. Epub 2011 Oct 6.