Alessandra Fabi1, Daniele Alesini2, Enrichetta Valle3, Luca Moscetti4, Roberta Caputo5, Michele Caruso6, Luisa Carbognin7, Mariangela Ciccarese8, Nicla La Verde9, Grazia Arpino10, Katia Cannita11, Ida Paris12, Daniele Santini13, Filippo Montemurro14, Michelangelo Russillo2, Gianluigi Ferretti2, Gianfranco Filippelli15, Rosalba Rossello16, Agnese Fabbri17, Alberto Zambelli18, Vita Leonardi19, Anna Maria D'Ottavio20, Cecilia Nisticò2, Simonetta Stani21, Marianna Giampaglia22, Giusy Scandurra23, Giovanna Catania2, Paola Malaguti2, Diana Giannarelli24, Francesco Cognetti2. 1. Oncologia Medica 1, Istituto Nazionale Tumori "Regina Elena", Roma, Italy. Electronic address: alessandra.fabi@virgilio.it. 2. Oncologia Medica 1, Istituto Nazionale Tumori "Regina Elena", Roma, Italy. 3. Oncologia Medica, Ospedale Businco, Cagliari, Italy. 4. Oncologia Medica, Ospedale Modena, Modena, Italy. 5. Breast Unit, Istituto Pascale, Napoli, Italy. 6. Humanitas Centro Catanese di Oncologia, Catania, Italy. 7. Oncologia Medica, Università di Verona, Italy. 8. Oncologia, Ospedale Vito Fazi, Lecce, Italy. 9. Oncologia Medica, PO Fatebenefratelli e Oftalmico, Milano, Italy. 10. Oncologia Medica, Università Federico II, Napoli, Italy. 11. Oncologia Medica, Ospedale S. Salvatore, Università dell'Aquila, Italy. 12. Oncologia e Ginecologica Polo Donna, Policlinico A.Gemelli, Roma, Italy. 13. Oncologia Medica, Campus Bio-medico Universitario, Roma, Italy. 14. Investigative Clinical Oncology, Cancer Institute-FPO, IRCCS, Candiolo, Torino, Italy. 15. Oncologia P.O. di Paola, Cosenza, Italy. 16. Oncologia Medica, Ospedale S. Vincenzo, Taormina, Messina, Italy. 17. Oncologia Medica, Ospedale Belcolle, Viterbo, Italy. 18. Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo, Italy. 19. Oncologia Medica, ARNAS Civico, Palermo, Italy. 20. Oncologia Medica, Ospedale San Giovanni, Roma, Italy. 21. Oncologia Medica, Ospedale Santo Spirito, Roma, Italy. 22. Oncologia Medica, Ospedale San Carlo, Potenza, Italy. 23. Oncologia Medica, Ospedale per le Emergenze Cannizzaro, Catania, Italy. 24. Unità di Biostatistica, Istituto Nazionale Tumori "Regina Elena", Roma, Italy.
Abstract
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.
BACKGROUND: We reported the results of an Italian large retrospective analysis that evaluated the effectiveness and safety of T-DM1 in 'field-practice' breast cancerpatients. 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 cancerpatients with BMs.
Authors: Brunilde Gril; Debbie Wei; Alexandra S Zimmer; Christina Robinson; Imran Khan; Simone Difilippantonio; Michael G Overstreet; Patricia S Steeg Journal: Neuro Oncol Date: 2020-11-26 Impact factor: 12.300
Authors: G Nader-Marta; D Martins-Branco; E Agostinetto; M Bruzzone; M Ceppi; L Danielli; M Lambertini; N Kotecki; A Awada; E de Azambuja Journal: ESMO Open Date: 2022-05-30
Authors: Anders W Erickson; Farinaz Ghodrati; Steven Habbous; Katarzyna J Jerzak; Arjun Sahgal; Manmeet S Ahluwalia; Sunit Das Journal: Neurooncol Adv Date: 2020-10-14