Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: A single-group, open-label, phase 2 study

The Lancet Oncology

Volumn 14, Issue 11, 2013, Pages 1121-1128

  Jones, Stephen E ^a   Collea, Rufus ^a,b   Paul, Devchand ^a,c   Sedlacek, Scot ^a,c   Favret, Anne M ^a,d   Gore, Ira ^a,e   Lindquist, Deborah L ^a,f   Holmes, Frankie Ann ^a,g   Allison, Mary Ann K ^a,h   Brooks, Barry D ^a,g   Portillo, Raul M ^a,g   Vukelja, Svetislava J ^g   Steinberg, Michael S ^a,i   Stokoe, Christopher ^a,g   Crockett, Maria W ^a   Wang, Yunfei ^a   Asmar, Lina ^a   Robert, Nicholas J ^a,g   O'Shaughnessy, Joyce ^a,g  

^a US Oncology Research   (United States)

^b New York Oncology Hematology   (United States)

^c Rocky Mountain Cancer Center   (United States)

^d Virginia Cancer Specialists   (United States)

^e University Alabama   (United States)

^f Arizona Oncology   (United States)

^g TEXAS ONCOLOGY   (United States)

^h Department of Translational Oncology   (United States)

ⁱ Virginia Oncology Associates   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

ADJUVANT THERAPY; ADULT; AGED; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CONGESTIVE HEART FAILURE; CONSTIPATION; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEVER; GENE; GENE AMPLIFICATION; HEADACHE; HEART DISEASE; HEART LEFT VENTRICLE EJECTION FRACTION; HER2 GENE; HOT FLUSH; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SIDE EFFECT; THROMBOCYTOPENIA; TOP2A GENE; TREATMENT OUTCOME; VOMITING;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, NEOPLASM; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DNA TOPOISOMERASES, TYPE II; DNA-BINDING PROTEINS; FEMALE; FOLLOW-UP STUDIES; GENE AMPLIFICATION; HUMANS; MIDDLE AGED; NEOPLASM STAGING; POLYMERASE CHAIN REACTION; PROGNOSIS; RECEPTOR, ERBB-2; SURVIVAL RATE; TAXOIDS; YOUNG ADULT;

EID: 84884699902     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70384-X     Document Type: Article

References (29)

1. Henderson IC, Berry D, Demetri G, et al. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 2003, 21:976-983.
2. Piccart MJ, Lohrisch C, Duchateau L, Buyse M Taxanes in the adjuvant treatment of breast cancer: why not yet?. J Natl Cancer Inst Monogr 2001, 30:88-95.
3. Mamounas EP, Bryant J, Lembersky B, et al. Paclitaxel after doxorubicin plus cyclophosphyamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol 2005, 23:3686-3696.
4. Fisher B, Brown AM, Dimitrov NV, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surigcal Adjuvant Breast and Bowel Project B-15. J Clin Oncol 1990, 8:1483-1496.
5. Fisher B, Anderson S, Tan-Chiu E, et al. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-234. J Clin Oncol 2001, 19:931-942.
6. Jones SE, Erban J, Overmoyer B, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 2005, 23:5434-5436.
7. Valero V Docetaxel and cyclophosphamide in patients with advanced solid tumors. Oncology (Williston Park) 1997, 11(suppl 6):21-23.
8. Jones SE, Savin MA, Holmes FA, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 2006, 24:5381-5387.
9. Jones SE, Holmes FA, O'Shaughnessy J, et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735. J Clin Oncol 2009, 27:1177-1183.
10. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792.
11. O'Malley FP, Chia S, Tu D Topoisomerase II alpha protein overexpression has predictive utility in a randomized trial comparing CMF to CEF in premenopausal women with node positive breast cancer (NCIC CTG MA. 5). Breast Cancer Res Treat 2006, 100:S18.
12. Press MF, Sauter G, Buyse M, et al. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol 2011, 29:859-867.
13. Slamon D, Eirmann W, Robert N, et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACàT) with doxorubicin and cyclophosphamide followed by docetexel and trastuzumab (ACàTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study (abstract 1). Breast Cancer Res Treat 2005, 94:S5.
14. Di Leo A, Desmedt C, Bartlett JM, et al. HER2 and TOP2A as predictive markers for anthracycline-containing chemotherapy regimens as adjuvant treatment of breast cancer: a meta-analysis of individual patient data. Lancet Oncol 2011, 12:1134-1142.
15. Perez EA, Jenkins RB, Dueck AC, et al. C-MYC alterations and association with patient outcome in early-stage HER2-positive breast cancer from the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. J Clin Oncol 2011, 29:651-659.
16. Kim C, Bryant J, Horne Z, et al. Trastuzumab sensitivity of breast cancer with coamplification of HER2 and c-MYC suggests proapoptotic function of dysregulated c-MYC in-vivo. Breast Cancer Res Treat 2005, 88(suppl 1):S6a.
17. Common Terminology Criteria for Adverse Events version 3.0 Cancer Therapy Evaluation Program, (accessed Aug 22, 2013). http://www.eortc.be/services/doc/ctc/ctcaev3.pdf.
18. Romond EH, Jeong JH, Rastogi P, et al. Seven-year follow-up assessment of cardiac function in NSABP B-31, a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with node-positive, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol 2012, 30:3792-3799.
19. Kaplan EL, Meier P Nonparametric estimation from incomplete observations. J Am Statis Assoc 1958, 53:457-481.
20. Clinical trial endpoints for the approval of cancer US Food and Drug Administration, (accessed Aug 22, 2013). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf.
21. 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.
22. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomized controlled trial. Lancet 2007, 369:29-36.
23. Fisher B, Brown A, Dimitrov N, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol 1990, 8:1483-1496.
24. Slamon D, Eirmann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011, 365:1273-1283.
25. Tan-Chiu E, Yothers G, Romond E, et al. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol 2005, 23:7811-7819.
26. De Boer RH, Chan A, Tran B, Wilcken N Use of non-anthracycline regimens in early stage breast cancer in Australia. Asia-Pacific J Clin Oncol 2011, 7:4-10.
27. Press MF, Sauter G, Buyse M, et al. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol 2011, 29:859-867.
28. Piccart-Gerbhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005, 353:1659-1672.
29. Robson D, Verma S Anthracyclines in early-stage breast cancer: is it the end of an era?. Oncologist 2009, 14:950-958.