> 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 people with breast cancer have HER2/neu-positive tumors. In these tumors, the HER2/neu receptor protein is over-expressed. The drug trastuzumab (Herceptin) targets the HER2/neu receptor protein on breast cancer cells. Trastuzumab has been shown to shrink tumors and to 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 increases. As with overall breast cancer, standard chemotherapy regimens that include an anthracycline appear to be better for HER2/neu-positive tumors than those without an anthracycline [1] (see Table 39).
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.
Study selection criteria: Phase III clinical trials with 100 or more participants and meta-analyses.
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Study
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Baseline Cohort
(number of participants)
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Follow-up
(years)
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Percent Surviving—
Standard Treatment Plus Trastuzumab
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Percent Surviving—
Standard Treatment
(no Trastuzumab)
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Absolute Improvement in Overall Survival Associated with Addition of Trastuzumab to Standard Treatment
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Phase III Clinical Trials
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HERA Study [2]
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5,102
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2
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92.4%
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89.7%
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2.7% Sig
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NSABP and NCCTG trials [3]
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3,351
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3
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94.3%
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91.7%
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2.5% NS
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4
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91.4%
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86.6%
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4.8% Sig
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FinHer Study [4]
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231
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3
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96.3%
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89.7%
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NS
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Meta-Analyses
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Dahabreh et al. [2-5]
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13,493
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2-3
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-
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-
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Sig
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Viani et al. [6]
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9,117
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2*
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94.0%
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91.5%
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Sig
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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 included 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. 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.
5. 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.
6. 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 09/12/09
