T-DM1 and brain metastases

Alessandra Fabi, Daniele Alesini, Enrichetta Valle, Luca Moscetti, Roberta Caputo, Michele Caruso, Luisa Carbognin, Mariangela Ciccarese, Nicla La Verde, Grazia Arpino, Katia Cannita, Ida Paris, Daniele Santini, Filippo Montemurro, Michelangelo Russillo, Gianluigi Ferretti, Gianfranco Filippelli, Rosalba Rossello, Agnese Fabbri, Alberto ZambelliVita Leonardi, Anna Maria D'Ottavio, Cecilia Nisticò, Simonetta Stani, Marianna Giampaglia, Giusy Scandurra, Giovanna Catania, Paola Malaguti, Diana Giannarelli, Francesco Cognetti

Research output: Contribution to journalArticlepeer-review


Background: We reported the results of an Italian large retrospective analysis that evaluated the effectiveness and safety of T-DM1 in ‘field-practice’ breast cancer patients. We performed a sub-analysis to investigate the clinical activity of T-DM1 in patients with brain metastases (BMs). Methods: The records of 87 adult women with HER2-positive breast cancer and BMs treated with T-DM1 were reviewed. Their clinical outcomes were compared with those of 216 patients without central nervous system (CNS) involvement. Results: Response to T-DM1 treatment in BMs was available for 53 patients in the BM group (60.9%): two patients reported a complete response (3.8%), 11 patients obtained partial response (20.7%; overall response rate: 24.5%), 16 patients had a stable disease (30.1%). Regarding extracranial disease, a total of 77 and 191 patients were evaluable for response in BM group and non-BM group, respectively. The overall response rate was 35.1% in the BM group and 38.3% in the non-BM group; disease control rate was 53.3% and 66.6%, respectively. At a median follow-up of 16 months (range: 1–55), median cumulative progression-free survival (PFS) was 7 months (95% CI: 5.4–8.6) in the BM group and 8 months (95% CI: 5.7–10.3) in the non-BM group. In the second-line setting, PFS was 5 (95% CI: 3.1–6.9) versus 11 (95% CI: 7.1–14.9) months (p = 0.01). Overall survival was 14 months (95% CI: 12.2–15.8) in the BM group and 32 months (95% CI: 24.4–39.6) in the non-BM group (p <0.0001). Conclusions: T-DM1 is active in breast cancer patients with BMs.
Original languageItalian
Pages (from-to)137-143
Number of pages7
Publication statusPublished - Oct 1 2018

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