Loss of HER2 and decreased T-DM1 efficacy in HER2 positive advanced breast cancer treated with dual HER2 blockade: the SePHER Study.


Journal

Journal of experimental & clinical cancer research : CR
ISSN: 1756-9966
Titre abrégé: J Exp Clin Cancer Res
Pays: England
ID NLM: 8308647

Informations de publication

Date de publication:
10 Dec 2020
Historique:
received: 04 09 2020
accepted: 02 12 2020
entrez: 11 12 2020
pubmed: 12 12 2020
medline: 7 9 2021
Statut: epublish

Résumé

HER2-targeting agents have dramatically changed the therapeutic landscape of HER2+ advanced breast cancer (ABC). Within a short time frame, the rapid introduction of new therapeutics has led to the approval of pertuzumab combined with trastuzumab and a taxane in first-line, and trastuzumab emtansine (T-DM1) in second-line. Thereby, evidence of T-DM1 efficacy following trastuzumab/pertuzumab combination is limited, with data from some retrospective reports suggesting lower activity. The purpose of the present study is to investigate T-DM1 efficacy in pertuzumab-pretreated and pertuzumab naïve HER2 positive ABC patients. We also aimed to provide evidence on the exposure to different drugs sequences including pertuzumab and T-DM1 in HER2 positive cell lines. The biology of HER2 was investigated in vitro through sequential exposure of resistant HER2 + breast cancer cell lines to trastuzumab, pertuzumab, and their combination. In vitro experiments were paralleled by the analysis of data from 555 HER2 + ABC patients treated with T-DM1 and evaluation of T-DM1 efficacy in the 371 patients who received it in second line. Survival estimates were graphically displayed in Kaplan Meier curves, compared by log rank test and, when possibile, confirmed in multivariate models. We herein show evidence of lower activity of T-DM1 in two HER2+ breast cancer cell lines resistant to trastuzumab+pertuzumab, as compared to trastuzumab-resistant cells. Lower T-DM1 efficacy was associated with a marked reduction of HER2 expression on the cell membrane and its nuclear translocation. HER2 downregulation at the membrane level was confirmed in biopsies of four trastuzumab/pertuzumab-pretreated patients. Among the 371 patients treated with second-line T-DM1, median overall survival (mOS) from diagnosis of advanced disease and median progression-free survival to second-line treatment (mPFS2) were 52 and 6 months in 177 patients who received trastuzumab/pertuzumab in first-line, and 74 and 10 months in 194 pertuzumab-naïve patients (p = 0.0006 and 0.03 for OS and PFS2, respectively). Our data support the hypothesis that the addition of pertuzumab to trastuzumab reduces the amount of available plasma membrane HER2 receptor, limiting the binding of T-DM1 in cancer cells. This may help interpret the less favorable outcomes of second-line T-DM1 in trastuzumab/pertuzumab pre-treated patients compared to their pertuzumab-naïve counterpart.

Sections du résumé

BACKGROUND BACKGROUND
HER2-targeting agents have dramatically changed the therapeutic landscape of HER2+ advanced breast cancer (ABC). Within a short time frame, the rapid introduction of new therapeutics has led to the approval of pertuzumab combined with trastuzumab and a taxane in first-line, and trastuzumab emtansine (T-DM1) in second-line. Thereby, evidence of T-DM1 efficacy following trastuzumab/pertuzumab combination is limited, with data from some retrospective reports suggesting lower activity. The purpose of the present study is to investigate T-DM1 efficacy in pertuzumab-pretreated and pertuzumab naïve HER2 positive ABC patients. We also aimed to provide evidence on the exposure to different drugs sequences including pertuzumab and T-DM1 in HER2 positive cell lines.
METHODS METHODS
The biology of HER2 was investigated in vitro through sequential exposure of resistant HER2 + breast cancer cell lines to trastuzumab, pertuzumab, and their combination. In vitro experiments were paralleled by the analysis of data from 555 HER2 + ABC patients treated with T-DM1 and evaluation of T-DM1 efficacy in the 371 patients who received it in second line. Survival estimates were graphically displayed in Kaplan Meier curves, compared by log rank test and, when possibile, confirmed in multivariate models.
RESULTS RESULTS
We herein show evidence of lower activity of T-DM1 in two HER2+ breast cancer cell lines resistant to trastuzumab+pertuzumab, as compared to trastuzumab-resistant cells. Lower T-DM1 efficacy was associated with a marked reduction of HER2 expression on the cell membrane and its nuclear translocation. HER2 downregulation at the membrane level was confirmed in biopsies of four trastuzumab/pertuzumab-pretreated patients. Among the 371 patients treated with second-line T-DM1, median overall survival (mOS) from diagnosis of advanced disease and median progression-free survival to second-line treatment (mPFS2) were 52 and 6 months in 177 patients who received trastuzumab/pertuzumab in first-line, and 74 and 10 months in 194 pertuzumab-naïve patients (p = 0.0006 and 0.03 for OS and PFS2, respectively).
CONCLUSIONS CONCLUSIONS
Our data support the hypothesis that the addition of pertuzumab to trastuzumab reduces the amount of available plasma membrane HER2 receptor, limiting the binding of T-DM1 in cancer cells. This may help interpret the less favorable outcomes of second-line T-DM1 in trastuzumab/pertuzumab pre-treated patients compared to their pertuzumab-naïve counterpart.

Identifiants

pubmed: 33302999
doi: 10.1186/s13046-020-01797-3
pii: 10.1186/s13046-020-01797-3
pmc: PMC7731769
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Biomarkers, Tumor 0
ERBB2 protein, human EC 2.7.10.1
Receptor, ErbB-2 EC 2.7.10.1
pertuzumab K16AIQ8CTM
Trastuzumab P188ANX8CK
Ado-Trastuzumab Emtansine SE2KH7T06F

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

279

Subventions

Organisme : Regina Elena Cancer Institute
ID : Intramural Grant

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Auteurs

Giulia Bon (G)

Cellular Network and Molecular Therapeutic Target Unit, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy. giulia.bon@ifo.gov.it.

Laura Pizzuti (L)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Valentina Laquintana (V)

Pathology Department, IRCCS Regina Elena National CancerInstitute, Rome, Italy.

Rossella Loria (R)

Cellular Network and Molecular Therapeutic Target Unit, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Manuela Porru (M)

Area of Translational Research, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Caterina Marchiò (C)

Department of Medical Sciences, University of Turin, Turin, Italy.
Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy.

Eriseld Krasniqi (E)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy. krasniqier@gmail.com.

Maddalena Barba (M)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Marcello Maugeri-Saccà (M)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Teresa Gamucci (T)

Medical Oncology, Sandro Pertini Hospital, Rome, Italy.

Rossana Berardi (R)

Oncology Clinic, "Ospedali Riuniti di Ancona" Hospital, Ancona, Italy.

Lorenzo Livi (L)

Radiotherapy Unit, Department of Oncology, Careggi University Hospital, Florence, Italy.

Corrado Ficorella (C)

Medical Oncology Unit, St Salvatore Hospital, L'Aquila, Italy.

Clara Natoli (C)

Department of Medical, Oral and Biotechnological Sciences, University Gabriele D'Annunzio, Chieti, Italy.

Enrico Cortesi (E)

Department of Medical Oncology, University La Sapienza, Rome, Italy.

Daniele Generali (D)

Breast Cancer Unit, ASST Cremona, Cremona, Italy.

Nicla La Verde (N)

Oncology Unit, ASST Fatebenefratelli Sacco-PO Fatebenefratelli, Milan, Italy.

Alessandra Cassano (A)

Oncology Unit, IRCCS Foundation Polyclinic University A. Gemelli, University Cattolica Del Sacro Cuore, Rome, Italy.

Emilio Bria (E)

Oncology Unit, IRCCS Foundation Polyclinic University A. Gemelli, University Cattolica Del Sacro Cuore, Rome, Italy.
University of Verona, Verona, Italy.

Luca Moscetti (L)

Department of Oncology and Hematology, University Hospital, Modena, Italy.

Andrea Michelotti (A)

UO Medical Oncology, S. Chiara Hospital, Pisa, Italy.

Vincenzo Adamo (V)

Medical Oncology Unit, A.O. Papardo & Department of Human Pathology, University of Messina, Messina, Italy.

Claudio Zamagni (C)

Medical Oncology Unit, Addarii Institute of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.

Giuseppe Tonini (G)

Department of Oncology, University Campus Biomedico, Rome, Italy.

Giacomo Barchiesi (G)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Marco Mazzotta (M)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Daniele Marinelli (D)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Medical Oncology Unit, Sant'Andrea University Hospital, Rome, Italy.

Silverio Tomao (S)

Department of Radiological, Oncological and Anatomo-Pathological Sciences, University La Sapienza, Umberto I University Hospital, Rome, Italy.

Paolo Marchetti (P)

Department of Medical Oncology, University La Sapienza, Rome, Italy.
Medical Oncology Unit, Sant'Andrea University Hospital, Rome, Italy.

Maria Rosaria Valerio (MR)

Medical Oncology, Paolo Giaccone University Hospital, Palermo, Italy.

Rosanna Mirabelli (R)

Department of Ematology & Oncology, Pugliese-Ciaccio Hospital, Catanzaro, Italy.

Antonio Russo (A)

Medical Oncology, Paolo Giaccone University Hospital, Palermo, Italy.

Maria Agnese Fabbri (MA)

Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy.

Nicola D'Ostilio (N)

Medical Oncology Unit, Lanciano-Vasto, Chieti, Italy.

Enzo Veltri (E)

Medical Oncology Unit, Santa Maria Goretti Hospital, Latina, Italy.

Domenico Corsi (D)

Medical Oncology Unit, Fatebenefratelli Hospital, Rome, Italy.

Ornella Garrone (O)

Medical Oncology AO S. Croce and Carle Teaching Hospital, Cuneo, Italy.

Ida Paris (I)

Gynaecology - Oncology Unit, University Cattolica del Sacro Cuore, Rome, Italy.

Giuseppina Sarobba (G)

Department of Medical Oncology, ASL Nuro, Nuoro, Italy.

Francesco Giotta (F)

Department of Medical Oncology, IRCCS Giovanni Paolo II, Bari, Italy.

Carlo Garufi (C)

Division of Medical Oncology, Pescara Hospital, Pescara, Italy.

Marina Cazzaniga (M)

Research Unit Phase I Trials and Oncology Unit, ASST, Monza, Italy.

Pietro Del Medico (P)

Division of Medical Oncology, Reggio Calabria General Hospital, Reggio Calabria, Italy.

Mario Roselli (M)

Department of Systems Medicine, Medical Oncology, University Tor Vergata, Rome, Italy.

Giuseppe Sanguineti (G)

Radiotherapy Department, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Isabella Sperduti (I)

Biostatistics Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Anna Sapino (A)

Department of Medical Sciences, University of Turin, Turin, Italy.
Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy.

Ruggero De Maria (R)

Institute of General Pathology, University Cattolica del Sacro Cuore, Rome, Italy.
Department of Medical Oncology, IRCCS Foundation University A. Gemelli, Rome, Italy.

Carlo Leonetti (C)

Area of Translational Research, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Angelo Di Leo (A)

Sandro Pitigliani Medical Oncology Department, Hospital of Prato, Prato, Italy.

Gennaro Ciliberto (G)

Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Rita Falcioni (R)

Cellular Network and Molecular Therapeutic Target Unit, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Patrizia Vici (P)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

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