Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2010;15(8):799-809.
doi: 10.1634/theoncologist.2009-0029. Epub 2010 Jul 29.

Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study

Jean-Marc Extra  1 , Eric C Antoine, Anne Vincent-Salomon, Thierry Delozier, Pierre Kerbrat, Anne Bethune-Volters, Jean-Paul Guastalla, Marc Spielmann, Louis Mauriac, Jean-Louis Misset, Daniel Serin, Mario Campone, Christophe Hebert, Céline Remblier, Loïc Bergougnoux, Frank Campana, Moïse Namer
Affiliations
Clinical Trial

Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study

Jean-Marc Extra et al. Oncologist. 2010.

Abstract

Background: The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP).

Patients and methods: The study observed 623 patients for > or = 2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for > or = 30 days following progression or stopped at or before progression.

Results: The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months).

Conclusion: The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.

PubMed Disclaimer

Conflict of interest statement

Disclosures: Jean-Marc Extra: None; Eric C. Antoine: Consultant/advisory role: Roche SAS; Anne Vincent-Salomon: None; Thierry Delozier: None; Pierre Kerbrat: None; Anne Bethune-Volters: None; Jean-Paul Guastalla: Consultant/advisory role: Roche, GlaxoSmithKline; Marc Spielmann: Consultant/advisory role: Roche, AstraZeneca, Novartis; Louis Mauriac: None; Jean-Louis Misset: None; Daniel Serin: None; Mario Campone: None; Christophe Hebert: None; Céline Remblier: None; Loïc Bergougnoux: None; Frank Campana: None; Moïse Namer: None.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials diagram of patients in the Hermine study.
Figure 2.
Figure 2.
Kaplan–Meier curve of time to progression (A) and overall survival (B) in the overall study population. Date of death was not recorded in five patients.
Figure 3.
Figure 3.
Kaplan–Meier plot comparing OS data from patients who continued trastuzumab beyond progression with that of patients who stopped trastuzumab treatment at or prior to progression from initiation of trastuzumab (A) and date of progression (B). Abbreviations: CI, confidence interval; OS, overall survival.
Figure 4.
Figure 4.
Independent prognostic survival factors for first-line trastuzumab in metastatic breast cancer. Abbreviations: CI, confidence interval; ER, estrogen receptor; PgR, progesterone receptor.
See this image and copyright information in PMC

Comment in

References

    1. Cobleigh MA, Vogel CL, Tripathy D, et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol. 1999;17:2639–2648. - PubMed
    1. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: A randomised controlled trial. Lancet. 2007;369:29–36. - PubMed
    1. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673–1684. - PubMed
    1. 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;23:4265–4274. - PubMed
    1. 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;344:783–792. - PubMed

Publication types

MeSH terms