> Table 42: Trastuzumab (Herceptin) and overall survival in early breast cancer
This summary table contains detailed information about research studies. While viewing summary tables offers an informative glimpse at the science behind many breast cancer guidelines and recommendations, they should be viewed with some caution. There are a number of concepts you must understand to be able to successfully read and interpret research tables. To get some background information about understanding research tables, please see How to Read a Research Table.
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Introduction: About 20 to 30 percent of breast cancers are HER2/neu-positive. This means surfaces of the cancer cells have a lot of HER2/neu receptor protein (this protein is over-expressed). The drug trastuzumab (Herceptin) targets the HER2/neu receptor protein on breast cancer cells.
Trastuzumab can shrink tumors and improve survival for those with HER2/neu-positive metastatic breast cancer (see Table 49). There is now evidence that, when added to standard chemotherapy regimens, trastuzumab is also useful in treating HER2/neu-positive early breast cancers.
Study results from phase III clinical trials in women with HER2/neu-positive early breast cancer have shown that standard chemotherapy plus trastuzumab increases overall survival. As with other breast cancers, HER2/neu-positve tumors respond better to treatment with chemotherapy regimens that include an anthracycline than to those without an anthracycline (see Table 39) [1].
Trastuzumab is not without risks. Compared to chemotherapy alone, chemotherapy plus trastuzumab increases the risk of heart problems. 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
|
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 Addition of Trastuzumab to Standard Treatment
|
Phase III clinical trials
|
HERA Study [2]
|
5,102
|
2
|
92.4%
|
89.7%
|
2.7% Sig
|
NSABP and NCCTG trials [3]
|
3,351
|
3
|
94.3%
|
91.7%
|
2.5% NS
|
| |
|
4
|
91.4%
|
86.6%
|
4.8% Sig
|
| Spielmann et al. [4] |
528 |
3.9 |
92.9% |
91.5% |
NS |
FinHer Study [5]
|
231
|
3
|
96.3%
|
89.7%
|
NS
|
Meta-analyses
|
Dahabreh et al. [2,3,5,6]
|
13,493
|
2-3
|
-
|
-
|
Sig
|
Viani et al. [7]
|
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. Gennari A, Sormani MP, Pronzato P, et al. HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: a pooled analysis of randomized trials. J Natl Cancer Inst. 100(1):14-20, 2008.
2. Smith I, Procter M, Gelber RD, et al. for the HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 369(9555):29-36, 2007.
3. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 353(16):1673-84, 2005.
4. 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.
5. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. for the FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 354(8):809-20, 2006.
6. 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.
7. 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 03/10/10
