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Recommendations for use of Trastuzumab (Herceptin®)

References

1 National Breast Cancer Centre. Clinical practice guidelines for the management of early breast cancer (2nd Edition). Canberra: Commonwealth of Australia, 2001.

2 National Breast Cancer Centre. Clinical practice guidelines for the management of advanced breast cancer. Canberra: Commonwealth of Australia, 2001.

3 Bilous M, Ades C, Armes J et al. Predicting the HER2 status of breast cancer from basic histopathology data: an analysis of 1500 breast cancers as part of the HER2000 International Study. The Breast 2003;12:92-98.*

4 Slamon D, Eiermann W, Robert N et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study. 2006.

5 Joensuu H, Kellokumpu-Lehtinen PL, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006;354(8):809-20.*

6 Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2positive breast cancer. N Engl J Med 2005;353(16):1673-84.

7 Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353(16):1659-72.

8 Smith I. Trastuzumab following adjuvant chemotherapy significantly improves disease-free survival and overall survival in early breast cancer with HER2 overexpression: the Breast International Group (BIG) HERA Trial. Paper presented at the American Society of Clinical Oncology (ASCO) 2006, Atlanta, Georgia, USA.*

9 Buzdar AU, Ibrahim NK, Francis D et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol 2005; 1:23(16):3676-85.

10 Gasparini G, Morabito A, De Sio L et al. Preliminary clinical results of a randomized phase IIb study of weekly paclitaxel (PCT) +/- trastuzumab (T) as first-line therapy of patients with HER-2/neu positive metastatic breast cancer. Breast Cancer Res Treat 2003;82(S1):S51(Abstr 227).

11 Marty M, Cognetti F, Maraninchi D et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: The M77001 Study Group. J Clin Oncol 2005;23:4265-74.

12 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(11):783-92.

13 Forbes JF, Pienkowski T, Valero V et al. BCIRG 007: Randomized phase III trial of trastuzumab plus docetaxel with or without carboplatin first line in HER2 positive metastatic breast cancer (MBC). 2006 ASCO Annual Meeting Proceedings J Clin Oncol 2006;24(18S):LBA516.*

14 Vogel CL, Cobleigh MA, Tripathy D et al. Efficacy and safety of trastuzumab as a single agent in first line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002;20(3):719-26.

15 Vogel CL, Cobleigh MA, Tripathy D et al. First-line Herceptin monotherapy in metastatic breast cancer. Oncology 2001;61(S2):37-42.

16 Seidman AD, Berry D, Cirrincione C et al. CALGB 9840: Phase III study of weekly (w) paclitaxel (P) via 1-hour(h) infusion versus standard (S) 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC: J Clin Oncol 2004;22(14S):512.

17 National Health and Medical Research Council. How to use the evidence: assessment and application of scientific evidence. Canberra, Commonwealth of Australia, 2000.

18 Halyard MY, Pisansky TM, Solin LJ et al. Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: Toxicity data from North Central Cancer treatment Group Phase III trial N9831. 2006 ASCO Annual Meeting Proceedings J Clin Oncol 2006;24(18S):523.*

19 National Cancer Institute Clinical Trials (PDQ ) NCCTG-N9831 http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=67953&version=HealthProfessional&p rotocolsearchid=2631790 Accessed September 15, 2006.

20 Hurley J, Doliny P, Reis I et al. Docetaxel, Cisplatin, and Trastuzumab As Primary Systematic Therapy for Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced Breast Cancer. J Clin Oncol 2006;24(12):1831-8.*

21 Robert N, Leyland-Jones B, Asmar L et al. Randomized Phase III study of Trastuzumab, Paclitaxel, and Carboplatin Compared With Trastuzumab and Paciltaxel in Women With HER-2 Overexpressing Metastatic Breast Cancer. J Clin Oncol 2006;24(18):2786-92*.

22 Kaufman B, Mackey J, Clemens M et al. trastuzumab plus anastrozole prolongs progression-free survival in postmenopausal women with HER2-positive, hormone-dependent metastatic breast cancer (MBC) Annals of Oncology 2006;17(S9):LAB2.*

23 Burstein HJ, Kuter I, Campos SM et al. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 2001;19(10):2722-30.

24 Burstein HJ, Harris LN, Marcom PK et al. Trastuzumab and vinorelbine as first-line therapy for HER2 overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol 2003;21(15):2889-95.

25 Jahanzeb M, Mortimer JE, Yunus F et al. Phase II trial of weekly vinorelbine and trastuzumab as first line therapy in patients with HER2(+) metastatic breast cancer. Oncologist 2002;7(5):410-7.

26 O Shaughnessy JA, Vukelja S, Marsland T et al. Phase II study of trastuzumab plus gemcitabine in chemotherapy-pretreated patients with metastatic breast cancer. Clin Breast Cancer 2004;5(2):142-7.

27 Papaldo P, Fabi A, Ferretti G et al. A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: changing the natural history of HER2-positive disease. Ann Oncol 2006;17(4):630-6.*

28 Moulder SL, Arteaga CL. A Phase I/II Trial of trastuzumab and gefitinib in patients with Metastatic Breast Cancer that overexpresses HER2/neu (ErbB-2). Clin Breast Cancer 2003;4(2):142-5.

29 Walshe JM, Denduluri N, Berman AW, Rosing DR, Swain SM. A Phase II Trial with Trastuzumab and Pertuzumab in Patients with HER2-Overexpressed Locally Advanced and Metastatic Breast Cancer. Clin Breast Cancer 2006;6(6):535-9.*

30 Baselga J, Tripathy D, Mendelsohn J et al. Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer. Semin Oncol 1999;26(4S12):78-83.

31 Baselga J, Carbonell X, Castaneda-Soto NJ et al. Phase II study of effi cacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005;23(10):2162-71.

32 Burstein HJ, Harris LN, Gelman R et al. Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/cyclophosphamide for HER2 overexpressing stage II or III breast cancer: a pilot study. J Clin Oncol 2003;21(1):46-53.

33 Coudert BP, Arnould L, Moreau L et al. Pre-operative systemic (neo-adjuvant) therapy with trastuzumab and docetaxel for HER2-overexpressing stage II or III breast cancer: results of a multicenter phase II trial. Ann Oncol 2006;17(3):409-14.*

34 Wenzel C, Hussian D, Bartsch R et al. Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study. J Cancer Res Clin Oncol 2004;130(7):400-4.

35 Burstein HJ, Lieberman G, Slamon DJ, iWiner EP& Klien P. Isolated central nervous system metastases in patients with HER2-overexpressing advanced breast cancer treated with first-line trastuzumab-based therapy. Annals of Oncology 2005;16:1772-1777.

36 Osoba D, Slamon DJ, Burchmore M, Murphy M. Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer. J Clin Oncol 2002;20(14):3106-13.

37 Mass RD, Sanders C, Charlene K et al. The concordance between the clinical trials assays (CTA) and fluorescence in situ hybridization (FISH) in the Herceptin pivotal trials. Proc Am Soc Clin Oncol 2000;19:291.

38 National Cancer Institute Clinical Trials (PDQ ) BIG-01-01(HERA) http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=256320&version=HealthProfessional&protocolsearchid=2631790 Accessed September 15 2006.

39 National Cancer Institute Clinical Trials (PDQ ) NSABP-B31 http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=67269&version=HealthProfessional&protocolsearchid=2631790 Accessed September 15, 2006.

40 National Cancer Institute Clinical Trials (PDQ ) UCLA-0102006 (BIRG-006) http://www.cancer.gov/ search/ViewClinicalTrials.aspx?cdrid=68763&version=HealthProfessional&protocolsearchid=263179 Accessed September 15 2006.

41 National Cancer Institute Clinical Trials (PDQ ) FRE-FNCLCC-PACS-04/0005 http://www.cancer.gov/ search/ViewClinicalTrials.aspx?cdrid=269909&version=HealthProfessional&protocolsearchid=26393 42 Accessed September 19 2006.

42 National Cancer Institute Clinical Trials (PDQ ) CLB-49808 http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=68617&version=HealthProfessional&p rotocolsearchid=2631790 Accessed September 15, 2006.

43 National Cancer Institute Clinical Trials (PDQ ) BGB-GEPARQUATTRO http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=455125&version=HealthProfessional&protocolsearchid=2631768 Accessed September 15, 2006.

44 National Cancer Institute Clinical Trials (PDQ ) ID99-146 http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=363913&version=HealthProfessional& protocolsearchid=2639342 Accessed September 19, 2006.

45 National Cancer Institute Clinical Trials (PDQ )SWS-SAKK-22/99 http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=67621&version=HealthProfessional&protocolsearchid=2631768 Accessed September 15, 2006.

46 National Cancer Institute Clinical Trials (PDQ ) EGF104383 http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=465515&version=HealthProfessional&protocolsearchid=2631768 Accessed September 15, 2006.

47 National Cancer Institute Clinical Trials (PDQ ) UCLA-0109024 (BCIRG-007) http://www.cancer. gov/search/ViewClinicalTrials.aspx?cdrid=257580&version=HealthProfessional&protocolsearchid=2 631790 Accessed September 15 2006.

48 National Cancer Institute Clinical Trials (PDQ ) SWOG SO347 http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=409573&version=HealthProfessional& protocolsearchid=2639342 Accessed September 19 2006.

49 National Cancer Institute Clinical Trials (PDQ ) GBG26 http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=447311&version=HealthProfessional&protocolsearchid=2631768 Accessed September 15, 2006.

50 National Cancer Institute Clinical Trials (PDQ ) EGF104900 http://www.cancer.gov/search/ ViewClinicalTrials.aspx?cdrid=484392&version=HealthProfessional&protocolsearchid=2631768 Accessed September 15, 2006.

*Articles considered by the Working Group but published after December 2005

Other articles of interest

Guarneri V, Lenihan DJ, Valero V et al. Long-term cardiac tolerability of trastuzumab in metastatic breastcancer: The M.D Anderson Cancer Center experience. J Clin Oncol 2006;24:4107-15.

Moshin SK, Weiss HL, Gutierrez MC et al. Neoadjuvant trastuzumab induces apoptosis in primary breast cancers. J Clin Oncol 2005;23(11):2460-8.

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-B31. J Clin Oncol 2005;23(31):7811-9.

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