T-DM1 and brain metastases: Clinical outcome in HER2-positive metastatic breast cancer

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 Zambelli; Vita Leonardi; Anna Maria D'Ottavio; Cecilia Nisticò; Simonetta Stani; Marianna Giampaglia; Giusy Scandurra; Giovanna Catania; Paola Malaguti; Diana Giannarelli; Francesco Cognetti

doi:10.1016/j.breast.2018.07.004

T-DM1 and brain metastases: Clinical outcome in HER2-positive metastatic breast cancer

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

Istituto Oncologico Candiolo

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	137-143
Number of pages	7
Journal	Breast
Volume	41
DOIs	https://doi.org/10.1016/j.breast.2018.07.004
Publication status	Published - Oct 2018

Keywords

Adult
Aged
Antineoplastic Agents, Immunological/therapeutic use
Brain Neoplasms/drug therapy
Breast Neoplasms/drug therapy
Female
Humans
Maytansine/analogs & derivatives
Middle Aged
Receptor, ErbB-2
Retrospective Studies
Survival Analysis
Trastuzumab/therapeutic use
Treatment Outcome

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Fabi, A., Alesini, D., Valle, E., Moscetti, L., Caputo, R., Caruso, M., Carbognin, L., Ciccarese, M., La Verde, N., Arpino, G., Cannita, K., Paris, I., Santini, D., Montemurro, F., Russillo, M., Ferretti, G., Filippelli, G., Rossello, R., Fabbri, A., ... Cognetti, F. (2018). T-DM1 and brain metastases: Clinical outcome in HER2-positive metastatic breast cancer. Breast, 41, 137-143. https://doi.org/10.1016/j.breast.2018.07.004

T-DM1 and brain metastases : Clinical outcome in HER2-positive metastatic breast cancer. / Fabi, Alessandra; Alesini, Daniele; Valle, Enrichetta; Moscetti, Luca; Caputo, Roberta; Caruso, Michele; Carbognin, Luisa; Ciccarese, Mariangela; La Verde, Nicla; Arpino, Grazia; Cannita, Katia; Paris, Ida; Santini, Daniele; Montemurro, Filippo; Russillo, Michelangelo; Ferretti, Gianluigi; Filippelli, Gianfranco; Rossello, Rosalba; Fabbri, Agnese; Zambelli, Alberto; Leonardi, Vita; D'Ottavio, Anna Maria; Nisticò, Cecilia; Stani, Simonetta; Giampaglia, Marianna; Scandurra, Giusy; Catania, Giovanna; Malaguti, Paola; Giannarelli, Diana; Cognetti, Francesco.

In: Breast, Vol. 41, 10.2018, p. 137-143.

Research output: Contribution to journal › Article › peer-review

Fabi, A, Alesini, D, Valle, E, Moscetti, L, Caputo, R, Caruso, M, Carbognin, L, Ciccarese, M, La Verde, N, Arpino, G, Cannita, K, Paris, I, Santini, D, Montemurro, F, Russillo, M, Ferretti, G, Filippelli, G, Rossello, R, Fabbri, A, Zambelli, A, Leonardi, V, D'Ottavio, AM, Nisticò, C, Stani, S, Giampaglia, M, Scandurra, G, Catania, G, Malaguti, P, Giannarelli, D & Cognetti, F 2018, 'T-DM1 and brain metastases: Clinical outcome in HER2-positive metastatic breast cancer', Breast, vol. 41, pp. 137-143. https://doi.org/10.1016/j.breast.2018.07.004

Fabi, Alessandra ; Alesini, Daniele ; Valle, Enrichetta ; Moscetti, Luca ; Caputo, Roberta ; Caruso, Michele ; Carbognin, Luisa ; Ciccarese, Mariangela ; La Verde, Nicla ; Arpino, Grazia ; Cannita, Katia ; Paris, Ida ; Santini, Daniele ; Montemurro, Filippo ; Russillo, Michelangelo ; Ferretti, Gianluigi ; Filippelli, Gianfranco ; Rossello, Rosalba ; Fabbri, Agnese ; Zambelli, Alberto ; Leonardi, Vita ; D'Ottavio, Anna Maria ; Nisticò, Cecilia ; Stani, Simonetta ; Giampaglia, Marianna ; Scandurra, Giusy ; Catania, Giovanna ; Malaguti, Paola ; Giannarelli, Diana ; Cognetti, Francesco. / T-DM1 and brain metastases : Clinical outcome in HER2-positive metastatic breast cancer. In: Breast. 2018 ; Vol. 41. pp. 137-143.

@article{7db56a349a65459bbe50246650b0431e,

title = "T-DM1 and brain metastases: Clinical outcome in HER2-positive metastatic breast cancer",

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.",

keywords = "Adult, Aged, Antineoplastic Agents, Immunological/therapeutic use, Brain Neoplasms/drug therapy, Breast Neoplasms/drug therapy, Female, Humans, Maytansine/analogs & derivatives, Middle Aged, Receptor, ErbB-2, Retrospective Studies, Survival Analysis, Trastuzumab/therapeutic use, Treatment Outcome",

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

year = "2018",

month = oct,

doi = "10.1016/j.breast.2018.07.004",

language = "English",

volume = "41",

pages = "137--143",

journal = "Breast",

issn = "0960-9776",

publisher = "Churchill Livingstone",

}

TY - JOUR

T1 - T-DM1 and brain metastases

T2 - Clinical outcome in HER2-positive metastatic breast cancer

AU - Fabi, Alessandra

AU - Alesini, Daniele

AU - Valle, Enrichetta

AU - Moscetti, Luca

AU - Caputo, Roberta

AU - Caruso, Michele

AU - Carbognin, Luisa

AU - Ciccarese, Mariangela

AU - La Verde, Nicla

AU - Arpino, Grazia

AU - Cannita, Katia

AU - Paris, Ida

AU - Santini, Daniele

AU - Montemurro, Filippo

AU - Russillo, Michelangelo

AU - Ferretti, Gianluigi

AU - Filippelli, Gianfranco

AU - Rossello, Rosalba

AU - Fabbri, Agnese

AU - Zambelli, Alberto

AU - Leonardi, Vita

AU - D'Ottavio, Anna Maria

AU - Nisticò, Cecilia

AU - Stani, Simonetta

AU - Giampaglia, Marianna

AU - Scandurra, Giusy

AU - Catania, Giovanna

AU - Malaguti, Paola

AU - Giannarelli, Diana

AU - Cognetti, Francesco

PY - 2018/10

Y1 - 2018/10

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Antineoplastic Agents, Immunological/therapeutic use

KW - Brain Neoplasms/drug therapy

KW - Breast Neoplasms/drug therapy

KW - Female

KW - Humans

KW - Maytansine/analogs & derivatives

KW - Middle Aged

KW - Receptor, ErbB-2

KW - Retrospective Studies

KW - Survival Analysis

KW - Trastuzumab/therapeutic use

KW - Treatment Outcome

U2 - 10.1016/j.breast.2018.07.004

DO - 10.1016/j.breast.2018.07.004

M3 - Article

C2 - 30092500

VL - 41

SP - 137

EP - 143

JO - Breast

JF - Breast

SN - 0960-9776

ER -