> Table 43: Trastuzumab (Herceptin) and overall survival in early breast cancer
This summary table contains detailed information about research studies. Summary tables offer an informative look at the science behind many breast cancer guidelines and recommendations. However, they should be viewed with some caution. In order to read and interpret research tables successfully, it is important to understand some key concepts. Learn how to read a research table.
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Introduction: About 15 to 20 percent of breast cancers are HER2/neu-positive [1-2]. This means surfaces of the cancer cells have a lot of HER2/neu receptor protein (you may also hear the term “HER2/neu over-expression”). The drug trastuzumab (Herceptin) targets the HER2/neu receptor protein on breast cancer cells.
Trastuzumab and survival
Trastuzumab was first shown to improve survival for those with HER2/neu-positive metastatic breast cancer (see Table 51). Now, it is also used to treat HER2/neu-positive early breast cancers.
Findings from studies in women with HER2/neu-positive early breast cancer show standard chemotherapy plus trastuzumab increases overall survival compared to chemotherapy alone.
Health risks
Trastuzumab is not without risks. Compared to chemotherapy alone, chemotherapy plus trastuzumab increases the risk of heart problems. This risk of heart problems may be higher with chemotherapy regimens that contain an anthracycline than with regimens without an anthracycline [3]. In rare cases, deaths due to heart failure have been linked to trastuzumab use.
Learn about the strengths and weaknesses of different types of studies.
Study selection criteria: Phase III clinical trials with 100 or more participants and meta-analyses.
Study
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Study Population
(number of participants)
|
Follow-up
(years)
|
Percent Surviving—
Standard Treatment plus Trastuzumab
|
Percent Surviving—
Standard Treatment Alone
(no Trastuzumab)
|
Absolute Improvement in Overall Survival with the Addition of Trastuzumab to Standard Treatment
|
Phase III clinical trials
|
NSABP and NCCTG trials [4]
|
4,045
|
3.9
|
92.9%
|
88.7%
|
4.2% Sig
|
HERA Study [5]
|
3,401
|
4
|
89.3%
|
87.7%
|
1.6% NS
|
Breast Cancer International Research Group [3]
|
3,222
|
5.4
|
91-92%
|
87%
|
4-5% Sig
|
Spielmann et al. [6]
|
528
|
3.9
|
92.9%
|
91.5%
|
NS
|
FinHer Study [7]
|
231
|
5.2
|
89.6%
|
81.9%
|
NS
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Meta-analyses
|
Dahabreh et al. [8]
|
13,493
|
2-3
|
-
|
-
|
Sig
|
Viani et al. [9]
|
9,117
|
2*
|
94.0%
|
91.5%
|
Sig
|
Sig = Statistically significant improvement compared to standard treatment alone.
NS = No statistically significant difference between the two treatment groups.
*About 2 years of follow-up for each study in the meta-analysis.
References
1. Carey LA, Perou CM, Livasy CA, et al. Race, breast cancer subtypes, and survival in the Carolina Breast cancer Study. JAMA. 295(21):2492-2502, 2006.
2. National Comprehensive Cancer Network. NCCN Guidelines for patients: Breast cancer. Version 2.2011. http://www.nccn.com, 2011.
3. Slamon D, Eiermann W, Robert N, et al. for the Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 365(14):1273-83, 2011.
4. 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. 29(25):3366-73, 2011.
5. Gianni L, Dafni U, Gelber RD, et al. for the Herceptin Adjuvant (HERA) Trial Study Team. 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. 12(3):236-244, 2011.
6. Spielmann M, Roché H, Delozier T, et al. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 27(36):6129-34, 2009.
7. Joensuu H, Bono P, Kataja V, Alanko T, et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial. J Clin Oncol. 27(34):5685-92, 2009.
8. Dahabreh IJ, Linardou H, Siannis F, Fountzilas G, Murray S. Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. Oncologist. 13(6):620-30, 2008.
9. Viani GA, Afonso SL, Stefano EJ, De Fendi LI, Soares FV. Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: a meta-analysis of published randomized trials. BMC Cancer. 7:153, 2007.
Updated 01/13/12
