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

2017; Impact Journals LLC; Volume: 8; Issue: 38 Linguagem: Inglês

10.18632/oncotarget.16373

1949-2553

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

Cancer Treatment and Pharmacology

// Alessandra Fabi 1 , Michelino De Laurentiis 2 , Michele Caruso 3 , Enrichetta Valle 4 , Luca Moscetti 5 , Daniele Santini 6 , Katia Cannita 7 , Luisa Carbognin 8 , Mariangela Ciccarese 9 , Rosalba Rossello 10 , Grazia Arpino 11 , Vita Leonardi 12 , Filippo Montemurro 13 , Nicla La Verde 14 , Daniele Generali 15 , Alberto Zambelli 16 , Giuseppa Scandurra 17 , Michelangelo Russillo 18 , Ida Paris 19 , Anna Maria D'Ottavio 20 , Gianfranco Filippelli 21 , Marianna Giampaglia 22 , Simonetta Stani 23 , Agnese Fabbri 24 , Daniele Alesini 1 , Daniela Cianniello 2 , Diana Giannarelli 25 and Francesco Cognetti 1 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 Abstract 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.