References
- Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist 2009;14:320-68
- Vogel UF. Confirmation of a low HER2 positivity rate of breast carcinomas - limitations of immunohistochemistry and in situ hybridization. Diagn Pathol 2010;5:50
- Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235:177-82
- Owens MA, Horten BC, Da Silva MM. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer 2004;5:63-9
- Seshadri R, Firgaira FA, Horsfall DJ, et al. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australian Breast Cancer Study Group. J Clin Oncol 1993;11:1936-42
- Tandon AK, Clark GM, Chamness GC, et al. HER-2/neu oncogene protein and prognosis in breast cancer. J Clin Oncol 1989;7:1120-8
- Andrulis IL, Bull SB, Blackstein ME, et al. neu/erbB-2 amplification identifies a poor-prognosis group of women with node-negative breast cancer. Toronto Breast Cancer Study Group. J Clin Oncol 1998;16:1340-9
- Paik S, Liu ET. HER2 as a predictor of therapeutic response in breast cancer. Breast Dis 2000;11:91-102
- 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;344:783-92
- Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-72
- Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-84
- Gianni L, Dafni U, Gelber RD, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol 2011;12:236-44
- Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol 2014;15:640-7
- Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011;365:1273-83
- Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol 2011;29:3366-73
- Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet 2013;382:1021-8
- Lamond NW, Younis T. Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations. Int J Womens Health 2014;6:509-21
- Prowell TM, Pazdur R. Pathological complete response and accelerated drug approval in early breast cancer. N Engl J Med 2012;366:2438-41
- Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-13
- Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev 2007;2:Cd005002
- Liedtke C, Mazouni C, Hess KR, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol 2008;26:1275-81
- Kurosumi M. Significance and problems in evaluations of pathological responses to neoadjuvant therapy for breast cancer. Breast Cancer 2006;13:254-9
- Rastogi P, Anderson SJ, Bear HD, et al. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol 2008;26:778-85
- von Minckwitz G, Untch M, Blohmer JU, et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012;30:1796-804
- Kim MM, Allen P, Gonzalez-Angulo AM, et al. Pathologic complete response to neoadjuvant chemotherapy with trastuzumab predicts for improved survival in women with HER2-overexpressing breast cancer. Ann Oncol 2013;24:1999-2004
- Kuerer HM, Newman LA, Smith TL, et al. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol 1999;17:460-9
- de Azambuja E, Holmes AP, Piccart-Gebhart M, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol 2014;15:1137-46
- Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014;384:164-72
- Food and Drug Administration. Center for Drug Evaluation and Research, Application Number: 125409Orig1s000, Cross Discipline Team Leader Review. Silver Spring, MD: US Department of Health & Human Services, 2013. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000CrossR.pdf. Accessed June 18, 2014
- Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol 2012;13:25-32
- Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol 2013;24:2278-84
- pCODR Expert Review Committee Final Recommendation for Pertuzumab (Perjeta Herceptin Combo Pack). Toronto, ON, Canada: Pan-Canadian Oncology Drug Review (pCODR), 2013. Last updated: August 1, 2013. http://www.pcodr.ca/idc/groups/pcodr/documents/pcodrdocument/pcodr-perjetacp-mbc-fn-rec.pdf. Accessed June 18, 2014
- Baselga J, Swain SM. CLEOPATRA: a phase III evaluation of pertuzumab and trastuzumab for HER2-positive metastatic breast cancer. Clin Breast Cancer 2010;10:489-91
- Swain SM, Kim SB, Cortes J, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013;14:461-71
- Hoffmann-La Roche Ltd. Pertuzumab (Perjeta®) Product Monograph. Mississauga, ON, Canada: Hoffmann-La Roche Ltd., 2014. http://www.rochecanada.com/fmfiles/re7234008/Research/ClinicalTrialsForms/Products/ConsumerInformation/MonographsandPublicAdvisories/Perjeta/Perjeta_PM_E.pdf. Accessed July 17, 2014
- Hedden L, O’Reilly S, Lohrisch C, et al. Assessing the real-world cost-effectiveness of adjuvant trastuzumab in HER-2/neu positive breast cancer. Oncologist 2012;17:164-71
- Mittmann N, Evans WK, Rocchi A, et al. Guidelines for health technologies: specific guidance for oncology products in Canada. Value Health 2012;15:580-5
- Hoffmann-La Roche. Weighted average weight of Canadian patients treated with trastuzumab from Cancer Care Ontario (CCO) and the British Columbia Cancer Agency (BCCA). Data on File. Mississauga, ON, Canada: Hoffmann-La Roche Ltd., 2012
- Statistics Canada. Canadian Health Measures Survey: Cycle 2 Data Table 22 - Measured standing height, by age and sex, household populations, Canada, 2009 to 2011. Ottawa, ON, Canada: Government of Canada, 2013. Last updated: June 19, 2014. http://www.statcan.gc.ca/pub/82-626-x/82-626-x2013001-eng.pdf. Accessed May 9, 2014
- Food and Drug Administration. Guidance for Industry - Pathologic complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval. Silver Spring, MD: US Department of Health & Human Services, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf. Accessed June 10, 2014
- Statistics Canada. Online Catologue 84-537-X: Table 1b - Complete life table, females, Canada, 2009-2011. Ottawa, ON, Canada: Government of Canada, 2013. http://www.statcan.gc.ca/pub/84-537-x/2013005/tbl/tbl1b-eng.htm. Accessed May 5, 2014
- Earle CC, Chapman RH, Baker CS, et al. Systematic overview of cost-utility assessments in oncology. J Clin Oncol 2000;18:3302-17
- Wolfson MC. Health-adjusted life expectancy. Statistics Canada Health Reports 1996;8:41-6
- Dranitsaris G, Cottrell W, Spirovski B, et al. Economic analysis of albumin-bound paclitaxel for the treatment of metastatic breast cancer. J Oncol Pharm Pract 2009;15:67-78
- Attard CL, Brown S, Alloul K, et al. Cost-effectiveness of folfirinox for first-line treatment of metastatic pancreatic cancer. Curr Oncol 2014;21:e41-51
- Younis T, Rayson D, Sellon M, et al. Adjuvant chemotherapy for breast cancer: a cost-utility analysis of FEC-D vs. FEC 100. Breast Cancer Res Treat 2008;111:261-7
- Ontario Drug Benefit Formulary. Ottawa, ON, Canada: Queen's Printer for Ontario, 2014. https://www.healthinfo.moh.gov.on.ca/formulary/. Accessed May 30, 2014
- Cancer Care Ontario. Docetaxel + Pertuzumab + Trastuzumab Regimen Monograph. Toronto, ON, Canada: Government of Ontario, 2014. https://www.cancercare.on.ca/CCO_DrugFormulary/Pages/DfPdfContent.aspx?itemId=282899. Accessed May 14, 2014
- Cancer Care Ontario. FEC100/FEC100-Trastuzumab Regimen Monograph. Toronto, ON, Canada: Government of Ontario, 2013. https://www.cancercare.on.ca/CCO_DrugFormulary/Pages/DfPdfContent.aspx?itemId=94861. Accessed May 14, 2014
- Cancer Care Ontario. FEC-D/FEC-D + Trastuzumab Regimen Monograph. Toronto, ON, Canada: Government of Ontario, 2014. https://www.cancercare.on.ca/CCO_DrugFormulary/Pages/DfPdfContent.aspx?itemId=94733. Accessed May 14, 2014
- Cancer Care Ontario. Systemic treatment funding model, nursing and pharmacy resource intensity weights/workloads for evidence-informed regimens. Toronto, ON, Canada: Government of Ontario, 2014. Available at: https://www.cancercare.on.ca/cms/one.aspx?portalId=1377&pageId=300183. Accessed May 30, 2014
- Cancer Care Ontario. Pertuzumab Drug Monograph. Toronto, ON, Canada: Government of Ontario, 2014. https://www.cancercare.on.ca/CCO_DrugFormulary/Pages/DfPdfContent.aspx?itemId=278249. Accessed May 14, 2014
- Mittmann N, Verma S, Koo M, et al. Cost effectiveness of TAC versus FAC in adjuvant treatment of node-positive breast cancer. Curr Oncol 2010;17:7-16
- Human Resources and Skills Development Canada. Work – Weekly hours worked, average hours worked per week in Ontario. 2012. http://www4.hrsdc.gc.ca/[email protected]?iid=19. Accessed May 30, 2014
- Government of Canada. Explore Careers - Wage Report for Pharmacist (NOC 3131-A) median salary ON. Toronto, ON, Canada: Government of Ontario, 2013. http://www.jobbank.gc.ca/LMI_report_bynoc.do?&noc=3131&reportOption=wage. Accessed May 30, 2014
- Government of Ontario. Schedule of benefits for physician services under the Health Insurance Act. Toronto, ON, Canada: Government of Ontario, 2013. http://www.health.gov.on.ca/english/providers/program/ohip/sob/physserv/physserv_mn.html. Accessed January 2, 2014
- OCCI Costing Analysis Tool. Ontario Case Costing Initiative. Toronto, ON, Canada: Government of Ontario, 2013. http://www.occp.com/mainPage.htm. Accessed May 13, 2014
- Government of Ontario. Schedule of Benefits for Laboratory Services. Toronto, ON, Canada: Government of Ontario, 1999. http://www.health.gov.on.ca/english/providers/program/ohip/sob/lab/lab_services_sched_01_19990401.pdf. Accessed January 14, 2014
- Madarnas Y, Joy AA, Verma S, et al. Models of care for early-stage breast cancer in Canada. Curr Oncol 2011;18(1 Suppl):S10-19
- Grunfeld E, Dhesy-Thind S, Levine M, et al. Clinical practice guidelines for the care and treatment of breast cancer: follow-up after treatment for breast cancer (summary of the 2005 update). CMAJ 2005;172:1319-20
- pCODR Expert Review Committee (pERC). Final Recommendation: Trastuzumab Emtansine (Kadcyla). Toronto, ON, Canada: Pan-Canadian Oncology Drug Review (pCODR), 2014. http://www.pcodr.ca/idc/groups/pcodr/documents/pcodrdocument/pcodr-kadcyla-mbc-fn-rec.pdf. Accessed July 18, 2014
- Robidoux A, Tang G, Rastogi P, et al. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial. Lancet Oncol 2013;14:1183-92
- Baselga J, Bradbury I, Eidtmann H, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 2012;379:633-40
- Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 2010;375:377-84
- Piccart-Gebhart MJ, Holmes AP, Baselga J, et al. First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T->L), or their combination (T + L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). ASCO Meeting Abstracts 2014;32(18 Suppl):LBA4
- Berry D. After the Plenary: In NeoALTTO and ALTTO Trials, Neoadjvuant Response Predicts Adjuvant. The Cancer Letter (Online). Washington DC: The Cancer Letter Inc., 2014 (July 11, 2014). http://www.thecancerletter.com/articles/20140711_2
- Sledge G. Counter-Point: George Sledge Responds to Berry’s Letter: neoadjuvant doesn't predict adjuvant in breast cancer and Berry’s rejoinder. The Cancer Letter (Online). Washington DC: The Cancer Letter Inc., 2014 (July 11, 2014). http://www.thecancerletter.com/articles/20140711_3
- Baselga J, Cortes J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012;366:109-19
- Will BP, Berthelot JM, Le Petit C, et al. Estimates of the lifetime costs of breast cancer treatment in Canada. Eur J Cancer 2000;36:724-35
- Lathia N, Mittmann N, DeAngelis C, et al. Evaluation of direct medical costs of hospitalization for febrile neutropenia. Cancer 2010;116:742-8