A phase ii pilot trial incorporating bevacizumab into dose-dense doxorubicin and cyclophosphamide followed by paclitaxel in patients with lymph node positive breast cancer: A trial coordinated by the Eastern Cooperative Oncology Group

Annals of Oncology

Volumn 23, Issue 2, 2012, Pages 331-337

  Miller, K D ^a   O'neill, A ^b   Perez, E A ^c   Seidman, A D ^d   Sledge, G W ^a  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c MAYO CLINIC CANCER CENTER   (United States)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Angiogenesis; Breast cancer; Cardiomyopathy; Clinical trial; Vascular endothelial growth factor

Indexed keywords

BEVACIZUMAB; CYCLOPHOSPHAMIDE; DOXORUBICIN; PACLITAXEL;

ADULT; AGED; ARTERY THROMBOSIS; ARTHRALGIA; ARTICLE; BLEEDING; BONE MARROW SUPPRESSION; BRAIN ISCHEMIA; BREAST ADENOCARCINOMA; CANCER ADJUVANT THERAPY; CANCER GRADING; CANCER GROWTH; CANCER RADIOTHERAPY; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; FEBRILE NEUTROPENIA; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE ISCHEMIA; HUMAN; HYPERTENSION; INFECTION; INTESTINE PERFORATION; LYMPH NODE; MAJOR CLINICAL STUDY; MASTECTOMY; MULTIPLE CYCLE TREATMENT; MYALGIA; NEPHROTIC SYNDROME; PHASE 2 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; PROTEINURIA; SENSORY NEUROPATHY; SIDE EFFECT; THROMBOSIS; VEIN THROMBOSIS; WOUND DEHISCENCE;

EID: 84856325150     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr344     Document Type: Article

References (30)

1. Jemal A, Siegel R, Ward E et al. Cancer statistics, 2009. CA Cancer J Clin 2009; 59: 225-249.
2. Parker S, Tong T, Bolden S et al. Cancer statistics, 1997. CA Cancer J Clin 1997; 47: 5-27.
3. Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med 2003; 9: 669-676.
4. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357: 2666-2676.
5. Miles DW, Chan A, Dirix LY et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010; 28: 3239-3247.
6. Robert N, Dieras V, Glaspy J et al. RIBBON-1: randomized, double-blind, placebocontrolled, phase III trial of chemotherapy with or without bevacizumab (B) for firstline treatment of HER2-negative locally recurrent or metastatic breast cancer (MBC). J Clin Oncol 2009; 27: 42s (Abstr 1005).
7. O'Shaughnessy J, Miles D, Gray R et al. A meta-analysis of overall survival data from three randomized trials of bevacizumab (BV) and first-line chemotherapy as treatment for patients with metastatic breast cancer (MBC). J Clin Oncol 2010; 28: 115s (Abstr 1005).
8. Miller KD, Gradishar W, Schuchter L et al. A randomized phase II pilot trial of adjuvant marimastat in patients with early-stage breast cancer. Ann Oncol 2002; 13: 1220-1224.
9. Miller KD, Saphner TJ, Waterhouse DM et al. A randomized phase II feasibility trial of BMS-275291 in patients with early stage breast cancer. Clin Cancer Res 2004; 10: 1971-1975.
10. Bryant J, Smith R, Margolese R et al. Increased gallbladder adverse events associated with octreotide pa LAR in patients with breast cancer. Proc Am Soc Clin Oncol 2001; 20: 50a (Abstr 197).
11. Wedam SB, Low JA, Yang SX et al. Antiangiogenic and antitumor effects of bevacizumab in patients with inflammatory and locally advanced breast cancer. J Clin Oncol 2006; 24: 769-777.
12. D'Adamo DR, Anderson SE, Albritton K et al. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol 2005; 23: 7135-7142.
13. Karp JE, Gojo I, Pili R et al. Targeting vascular endothelial growth factor for relapsed and refractory adult acute myelogenous leukemias: therapy with sequential 1-beta-d-arabinofuranosylcytosine, mitoxantrone, and bevacizumab. Clin Cancer Res 2004; 10: 3577-3585.
14. Sandler A, Gray R, Perry MC et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355: 2542-2550.
15. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350: 2335-2342.
16. Citron ML, Berry DA, Cirrincione C et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 2003; 21: 1431-1439.
17. Scappaticci FA, Skillings JR, Holden SN et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 2007; 99: 1232-1239.
18. McGowan JH, Cleland JG. Reliability of reporting left ventricular systolic function by echocardiography: a systematic review of 3 methods. Am Heart J 2003; 146: 388-397.
19. Massardo T, Jaimovich R, Lavados H et al. Comparison of radionuclide ventriculography using SPECT and planar techniques in different cardiac conditions. Eur J Nucl Med Mol Imaging 2007; 34: 1735-1746.
20. Hiscock SC, Evans MJ, Morton RJ et al. Investigation of normal ranges for left ventricular ejection fraction in cardiac gated blood pool imaging studies using different processing workstations. Nucl Med Commun 2008; 29: 103-109.
21. Perez EA, Suman VJ, Davidson NE et al. Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial. J Clin Oncol 2008; 26: 1231-1238.
22. Yardley DA. Integrating bevacizumab into the treatment of patients with early-stage breast cancer: focus on cardiac safety. Clin Breast Cancer 2010; 10: 119-129.
23. McArthur H, Rugo H, Nulsen B et al. Cardiac safety of adjuvant bevacizumab (B) plus dose-dense doxorubicin/cyclophosphamide (AC) followed by nanoparticle albumin-bound paclitaxel (nab-P) in patients with early stage breast cancer. Breast Cancer Res Treat 2008;; 288s (Abstr 4104).
24. McArthur H, Rugo H, Nulsen B et al. Troponins do not predict cardiotoxicity in a pilot study of adjuvant bevacizumab (B) plus dose-dense doxorubicin/ cyclophosphamide (AC) followed by nanoparticle Albumin-Bound Paclitaxel (nab-P). Cancer Res 2009; 69 (Supp 24): 675s.
25. Yardley D, Hart L, Waterhouse D et al. Preliminary safety results: addition of bevacizumab to 3 docetaxel regimens as adjuvant therapy for early stage breast cancer, Cancer Res. 2009; 69 (Supp 2): 289s (Abstr 4107).
26. Mayer E, Nohria A, Miller K et al. Cardiovascular safety of adjuvant bevacizumab for breast cancer. J Clin Oncol 2010; 28 (Suppl): 84s (Abstr 571).
27. Pinder MC, Duan Z, Goodwin JS et al. Congestive heart failure in older women treated with adjuvant anthracycline chemotherapy for breast cancer. J Clin Oncol 2007; 25: 3808-3815.
28. Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005; 353: 1673-1684.
29. Partridge AH, LaFountain A, Mayer E et al. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 2008; 26: 556-562.
30. Langmuir V, Cobleigh M, Herbst R et al. Successful long-term therapy with bevacizumab (Avastin) in solid tumors. Proc Am Soc Clin Oncol 2002; 21: 9a.