A feasibility study of bevacizumab plus dose-dense doxorubicin- cyclophosphamide (AC) followed by nanoparticle albumin-bound paclitaxel in early-stage breast cancer Journal Article


Authors: Mcarthur, H. L.; Rugo, H.; Nulsen, B.; Hawks, L.; Grothusen, J.; Melisko, M.; Moasser, M.; Paulson, M.; Traina, T.; Patil, S.; Zhou, Q.; Steingart, R.; Dang, C.; Morrow, M.; Cordeiro, P.; Fornier, M.; Park, J.; Seidman, A.; Lake, D.; Gilewski, T.; Theodoulou, M.; Modi, S.; D'Andrea, G.; Sklarin, N.; Robson, M.; Moynahan, M. E.; Sugarman, S.; Sealey, J. E.; Laragh, J. H.; Merali, C.; Norton, L.; Hudis, C. A.; Dickler, M. N.
Article Title: A feasibility study of bevacizumab plus dose-dense doxorubicin- cyclophosphamide (AC) followed by nanoparticle albumin-bound paclitaxel in early-stage breast cancer
Abstract: Purpose: Bevacizumab confers benefits in metastatic breast cancer but may be more effective as adjuvant therapy. We evaluated the cardiac safety of bevacizumab plus dose-dense doxorubicin-cyclophosphamide (ddAC) → nanoparticle albumin-bound (nab)-paclitaxel in human epidermal growth factor receptor 2 normal early-stage breast cancer. Experimental Design: Eighty patients with normal left ventricular ejection fraction (LVEF) were enrolled. Bevacizumab was administered for 1 year, concurrently with ddAC → nab-paclitaxel then as a single agent. LVEF was evaluated at months 0, 2, 6, 9, and 18. This regimen was considered safe if fewer than three cardiac events or fewer than two deaths from left ventricular dysfunction occurred. Correlative studies of cardiac troponin (cTn) and plasma renin activity (PRA) were conducted. Results: The median age was 48 years (range, 27-75 years), and baseline LVEF was 68% (53%-82%). After 39 months' median follow-up (5-45 months): median LVEF was 68% (53%-80%) at 2 months (n = 78), 64% (51%-77%) at 6 months (n=66), 63% (48%-77%) at 9 months (n=61), and 66% (42%-76%) at 18 months (n = 54). One patient developed symptomatic LV dysfunction at month 15. Common toxicities necessitating treatment discontinuation were hypertension (HTN, 4%), wound-healing complications (4%), and asymptomatic LVEF declines (4%). Neither cTn nor PRA predicted congestive heart failure (CHF) or HTN, respectively. Conclusions: Bevacizumab with ddAC → nab-paclitaxel had a low rate of cardiac events; cTn and PRA levels are not predictive of CHF or HTN, respectively. The efficacy of bevacizumab as adjuvant treatment will be established in several ongoing phase III trials. ©2011 AACR.
Journal Title: Clinical Cancer Research
Volume: 17
Issue: 10
ISSN: 1078-0432
Publisher: American Association for Cancer Research  
Date Published: 2011-05-15
Start Page: 3398
End Page: 3407
Language: English
DOI: 10.1158/1078-0432.ccr-10-1969
PROVIDER: scopus
PUBMED: 21350003
PMCID: PMC4994894
DOI/URL:
Notes: --- - "Export Date: 23 June 2011" - "CODEN: CCREF" - "Source: Scopus"
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MSK Authors
  1. Sujata Patil
    383 Patil
  2. Monica Morrow
    439 Morrow
  3. Andrew D Seidman
    244 Seidman
  4. Clifford Hudis
    840 Hudis
  5. Larry Norton
    563 Norton
  6. Nancy T Sklarin
    46 Sklarin
  7. Mark E Robson
    365 Robson
  8. Chau Dang
    156 Dang
  9. Diana E Lake
    70 Lake
  10. Maura N Dickler
    237 Dickler
  11. Richard M Steingart
    113 Steingart
  12. Qin Zhou
    120 Zhou
  13. Peter G Cordeiro
    239 Cordeiro
  14. Monica Nancy Fornier
    136 Fornier
  15. Tiffany A Traina
    153 Traina
  16. Shanu Modi
    132 Modi
  17. Benjamin Francis Nulsen
    8 Nulsen
  18. Laura C Hawks
    2 Hawks