Clinical Research Papers:

Efficacy and safety of T-DM1 in the ‘common-practice’ of HER2+ advanced breast cancer setting: a multicenter study

Alessandra Fabi _, Michelino De Laurentiis, Michele Caruso, Enrichetta Valle, Luca Moscetti, Daniele Santini, Katia Cannita, Luisa Carbognin, Mariangela Ciccarese, Rosalba Rossello, Grazia Arpino, Vita Leonardi, Filippo Montemurro, Nicla La Verde, Daniele Generali, Alberto Zambelli, Giuseppa Scandurra, Michelangelo Russillo, Ida Paris, Anna Maria D’Ottavio, Gianfranco Filippelli, Marianna Giampaglia, Simonetta Stani, Agnese Fabbri, Daniele Alesini, Daniela Cianniello, Diana Giannarelli and Francesco Cognetti

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Oncotarget. 2017; 8:64481-64489. https://doi.org/10.18632/oncotarget.16373

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Alessandra Fabi1, Michelino De Laurentiis2, Michele Caruso3, Enrichetta Valle4, Luca Moscetti5, Daniele Santini6, Katia Cannita7, Luisa Carbognin8, Mariangela Ciccarese9, Rosalba Rossello10, Grazia Arpino11, Vita Leonardi12, Filippo Montemurro13, Nicla La Verde14, Daniele Generali15, Alberto Zambelli16, Giuseppa Scandurra17, Michelangelo Russillo18, Ida Paris19, Anna Maria D’Ottavio20, Gianfranco Filippelli21, Marianna Giampaglia22, Simonetta Stani23, Agnese Fabbri24, Daniele Alesini1, Daniela Cianniello2, Diana Giannarelli25 and Francesco Cognetti1

1 Oncologia Medica 1, Istituto Nazionale Tumori “Regina Elena”, Roma, Italy

2 Breast Unit, Istituto Pascale, Napoli, Italy

3 Humanitas Centro Catanese di Oncologia, Catania, Italy

4 Oncologia Medica, Ospedale Businco, Cagliari, Italy

5 Oncologia Medica, Ospedale Modena, Modena, Italy

6 Oncologia Medica, Campus Bio-medico Universitario, Roma, Italy

7 Oncologia Medica Ospedale L’Aquila, L’Aquila, Italy

8 Oncologia Medica, Università di Verona, Verona, Italy

9 Oncologia, Ospedale Vito Fazi, Lecce, Italy

10 UOC di Oncologia medica, Ospedale S. Vincenzo, Taormina, Messina, Italy

11 Oncologia Medica, Università Federico II, Napoli, Italy

12 Oncologia medica, ARNAS Civico, Palermo, Italy

13 Fondazione del Piemonte per l’Oncologia, Itituto Tumori Candiolo, Torino, Italy

14 Oncologia Medica, ASST Fatebenefratelli Sacco, PO Fatebenefratelli e Oftalmico, Milano, Italy

15 Dipartimento Universitario Clinico di Scienze Mediche, Chirurgiche e della Salute, Università degli Studi di Trieste, Trieste, Italy

16 Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo, Italy

17 Oncologia Medica, Ospedale per le Emergenze Cannizzaro, Catania, Italy

18 Dipartimento Oncologico USL Toscana nord-ovest , Ospedale San Luca, Lucca, Italy

19 Oncologia e Ginecologica Polo Donna, Policlinico A.Gemelli, Roma, Italy

20 Oncologia, Ospedale San Giovanni, Roma, Italy

21 Oncologia P.O. di Paola, ASP di Cosenza, Cosenza, Italy

22 Oncologia Medica, Ospedale San Carlo, Potenza, Italy

23 Oncologia Medica, Ospedale Santo Spirito, Roma, Italy

24 UOC Oncologia, Ospedale Belcolle, Viterbo, Italy

25 Unità di Biostatistica, Istituto Nazionale Tumori “Regina Elena”, Roma, Italy

Correspondence to:

Alessandra Fabi, email:

Keywords: HER2, metastatic breast cancer, trastuzumab, taxane, ado-trastuzumab emtansine

Received: February 07, 2017 Accepted: March 06, 2017 Published: March 18, 2017


Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate approved for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer (mBC). The aim of this ‘field-practice’ study was to investigate the efficacy and safety of T-DM1, focusing on treatment line, previous lapatinib treatment and patterns of metastasis. Three hundred and three patients with HER2-positive mBC who received T-DM1 were identified by reviewing the medical records of 24 Italian Institutions. One hundred fourty-nine (49%) and 264 (87%) had received prior hormonal treatment and/or anti-HER2 targeted therapy, respectively. Particularly, 149 patients had been previously treated with lapatinib. The objective response rate (ORR) was 36.2%, and 44.5% when T-DM1 was administrated as second-line therapy. Considering only patients with liver metastases, the ORR was 44.4%. The median progression-free survival (PFS) was 7.0 months in the overall population, but it reached 9.0 and 12.0 months when TDM-1 was administered as second- and third-line treatment, respectively.

In conclusion, in this ‘real-word’ study evaluating the effects of T-DM1 in patients with HER2-positive mBC who progressed on prior anti-HER2 therapies, we observed a clinically-relevant benefit in those who had received T-DM1 in early metastatic treatment-line and in subjects previously treated with lapatinib.

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