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
. 2017 May 25;8(34):56921-56931.
doi: 10.18632/oncotarget.18176. eCollection 2017 Aug 22.

A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience

Patrizia Vici  1 , Laura Pizzuti  1 , Andrea Michelotti  2 , Isabella Sperduti  3 , Clara Natoli  4 , Lucia Mentuccia  5 , Luigi Di Lauro  1 , Domenico Sergi  1 , Paolo Marchetti  6 , Daniele Santini  7 , Emanuela Magnolfi  5 , Laura Iezzi  4 , Luca Moscetti  8 , Agnese Fabbri  9 , Alessandra Cassano  10 , Antonino Grassadonia  4 , Claudia Omarini  11 , Federico Piacentini  11 , Andrea Botticelli  6 , Ilaria Bertolini  2 , Angelo Fedele Scinto  12 , Germano Zampa  13 , Maria Mauri  14 , Loretta D'Onofrio  7 , Valentina Sini  6 , Maddalena Barba  1 , Marcello Maugeri-Saccà  1 , Ernesto Rossi  10 , Elisabetta Landucci  2 , Silverio Tomao  15 , Antonio Maria Alberti  16 , Francesco Giotta  17 , Corrado Ficorella  18 , Vincenzo Adamo  19 , Antonio Russo  20 , Vito Lorusso  17 , Katia Cannita  18 , Sandro Barni  21 , Lucio Laudadio  22 , Filippo Greco  23 , Ornella Garrone  24 , Marina Della Giulia  1 , Paolo Marolla  1 , Giuseppe Sanguineti  25 , Barbara Di Cocco  26 , Gennaro Ciliberto  27 , Ruggero De Maria  28 , Teresa Gamucci  5
Affiliations

A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience

Patrizia Vici et al. Oncotarget. .

Abstract

We addressed trastuzumab emtansine (T-DM1) efficacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab-pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing significant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical benefit 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no differences emerged by pertuzumab pretreatment, with median progression-free and median overall survival of 4 and 17 months in pertuzumab-pretreated (p=0.13), and 6 and 22 months in pertuzumab-naïve patients (p=0.27). Patients who received second-line T-DM1 had median progression-free and median overall survival of 3 and 12 months (p=0.0001) if pertuzumab-pretreated, and 8 and 26 months if pertuzumab-naïve (p=0.06). In contrast, in third-line and beyond, median progression-free and median overall survival were 16 and 18 months in pertuzumab-pretreated (p=0.05) and 6 and 17 months in pertuzumab-naïve patients (p=0.30). In multivariate analysis, lower ECOG performance status was associated with progression-free survival benefit (p<0.0001), while overall survival was positively affected by lower ECOG PS (p<0.0001), absence of brain metastases (p 0.05), and clinical benefit (p<0.0001). Our results are comparable with those from randomized trials. Further studies are warranted to confirm and interpret our data on apparently lower T-DM1 efficacy when given as second-line treatment after pertuzumab, and on the optimal sequence order.

Keywords: HER2 positive; T-DM1; metastatic breast cancer; previous pertuzumab; real-world.

PubMed Disclaimer

Conflict of interest statement

CONFLICTS OF INTEREST The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Progression-free survival (PFS, A) and overall survival (OS, B) in the overall population. No: number.
Figure 2
Figure 2
Progression-free survival (A) and overall survival (B) in patients who received T-DM1 as second-line or beyond according to pertuzumab pre-treatment. PFS: progression-free survival; OS: overall survival; No: number.
See this image and copyright information in PMC

References

    1. Dawood S, Broglio K, Buzdar AU, Hortobagyi GN, Giordano SH. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol. 2010;28:92–98. - PMC - PubMed
    1. Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32:2078–2099. - PMC - PubMed
    1. 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. 2007;7:153. - PMC - PubMed
    1. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. 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
    1. Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Antón A, Lluch A, Kennedy J, O’Byrne K, Conte P, 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