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Real-world effectiveness of dual HER2 blockade with pertuzumab and trastuzumab for neoadjuvant treatment of HER2-positive early breast cancer (The NEOPETRA Study)

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Abstract

Purpose

Neoadjuvant clinical trials with dual HER2 blockade with pertuzumab and trastuzumab plus chemotherapy demonstrated high rates of pathological complete response (pCR) in HER2-positive early breast cancer (BC). We investigated whether the benefit on pCR seen in clinical trials is confirmed in a real-world setting.

Methods

Multicenter, retrospective study in patients with HER2-positive early BC receiving neoadjuvant treatment with pertuzumab and trastuzumab in routine clinical practice (n = 243). The primary endpoint was total pCR (tpCR) (ypT0/is ypN0).

Results

A total of 243 evaluable patients were included. Pertuzumab and trastuzumab were combined with anthracyclines and taxanes in 74.1% of patients, with single-agent taxane in 11.1% of patients and with platinum-based chemotherapy (CT) in 14.4% of patients. The tpCR rate was 66.4%:71% with anthracyclines and taxanes, 59.3% with single-agent taxane, and 48.6% with platinum-based combinations. The tpCR rate was higher among patients with hormone receptor (HR)-negative tumors (80.9%) vs HR-positive tumors (55.4%) (p < 0.001). A pCR in the breast (ypT0/is) was achieved in 67.6% of patients. Of 143 patients who showed radiological complete response (rCR) (62%), 112 (78.3%) patients also achieved tpCR. Assessment of rCR by magnetic resonance imaging (MRI) showed the highest negative predictive value (NPV) for predicting tpCR (83.5%). Breast-conserving surgery was performed in 58.7% of patients. Grade 3 and grade 4 toxicities were reported in 33 (18.2%) and 12 (6.6%) patients, respectively. No toxicity leading to death was reported.

Conclusions

This real-world analysis shows that neoadjuvant pertuzumab, trastuzumab, and chemotherapy achieve comparable or even higher rates of tpCR than those seen in clinical trials. The pCR benefit is higher in HR-negative tumors. The assessment of rCR by MRI showed the highest ability for predicting pCR. In addition, this neoadjuvant strategy confers an acceptable safety profile.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Qualified researchers may request access to individual patient-level data through the clinical study data request platform (https://vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).”

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Acknowledgements

The authors would like to thank the NEOPETRA study investigators for their contribution to the study: Fernando Moreno Antón, Hospital Clínico San Carlos, Madrid (Spain); Salvador Blanch Tormo, Instituto Valenciano de Oncología, Valencia (Spain); Noelia Martínez Jañez, Hospital Ramón y Cajal, Madrid (Spain); Elena Galve Calvo, Hospital de Basurto, Bilbao (Spain), Jesús García Mata, Complejo Hospitalario de Orense, Orense (Spain); and Laura García, HM Sanchinarro, Madrid (Spain). We also thank the patients who consented to participate in this study. We thank Roche Farma S.A. for supporting the study. In particular, we would like to acknowledge Pablo López Pedrola and Marian Terrancle from Roche Farma for their support during the study. The authors would also like to thank Cristina Vidal and Antonio Torres, from Dynamic Science (Spain), for their medical writing and editorial support, funded by Roche Farma S.A.

Funding

The study was sponsored by Roche Farma S.A.

Author information

Author notes

  1. Eva Ciruelos

    Present address: HM CIOCC (for its acronym in Spanish: Centro Integral Oncológico Clara Campal), Madrid, Spain

  2. Maria Isabel Gallegos Sancho

    Present address: MD Anderson Cancer Center, Madrid, Spain

Authors and Affiliations

  1. Servicio de Oncología Médica, Hospital Universitario San Pedro de Alcántara, Avda. Pablo Naranjo, s/n, 10003, Cáceres, Spain

    Santiago González-Santiago

  2. Hospital Universitario Vall d’Hebron, Vall d’Hebrón Instituto de Oncologia (VHIO), Barcelona, Spain

    Cristina Saura

  3. Hospital Universitario 12 de Octubre, Madrid, Spain

    Eva Ciruelos

  4. Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain

    José Luis Alonso

  5. Hospital General Universitario J.M. Morales Meseguer, Murcia, Spain

    Pilar de la Morena

  6. Clínica Universidad de Navarra, Pamplona, Spain

    Marta Santisteban Eslava

  7. Hospital General de Segovia, Segovia, Spain

    Maria Isabel Gallegos Sancho

  8. Hospital Clínico San Carlos, Madrid, Spain

    Alicia de Luna

  9. ParcTaulí Hospital Universitari, Sabadell, Barcelona, Spain

    Elsa Dalmau

  10. Hospital del Mar, Barcelona, Spain

    Sonia Servitja

  11. Hospital Universitario Virgen del Rocío, Sevilla, Spain

    Manuel Ruiz Borrego

  12. Hospital Virgen de la Salud, Toledo, Spain

    José Ignacio Chacón

  13. SOLTI Breast Cancer Research Cooperative Group, Barcelona, Spain

    Cristina Saura & Eva Ciruelos

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  1. Santiago González-Santiago
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Contributions

SGS and JIC have contributed to the design, acquisition of data, data analysis and interpretation, and manuscript preparation and review. CS, EC, JLA, PM, MSE, IG, AL, ED, SS, and MRB have contributed to the acquisition of data and manuscript review. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Santiago González-Santiago.

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Conflict of interest

S. González-Santiago has received speaker honoraria from Amgen, Eisai, Novartis, Roche, Pfizer and AstraZeneca, has served in an advisory role for Amgen, Novartis, Roche, Celgene, AstraZeneca and Pfizer, and has received travel expenses from Pfizer, MSD, and Roche. E. Ciruelos has received personal fees from Roche, Lilly, Novartis, and Pfizer. S. Servitja reported speaker bureau honoraria and travel support from Roche. M. Ruiz Borrego has received a speaker’s grant and has served on the advisory board for Roche. The other authors declare that they do not have any conflict of interest.

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Not applicable as this manuscript does not contain any individual person’s data.

Ethical approval

The study was conducted in accordance with the Declaration of Helsinki and its later amendments. The Research Ethics Committee of Parc Taulí Hospital (Sabadell, Barcelona Spain) approved this study.

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Written informed consent was obtained from all individual participants included in the study to collect data from medical charts retrospectively.

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Supplementary file1 (EPS 2263 kb)

Supplementary Figure 1. pCR rates with neoadjuvant dual HER2 blockade with pertuzumab and trastuzumab in the neoadjuvant trials in patients with HER2-positive BC. A: Anthracyclines; T: Taxanes; TP: Trastuzumab+pertuzumab; Pbc: Platinum based combinations; A→T+TP; Anthracyclines followed by taxanes and trastuzumab+pertuzumab; A + TP → T + Pbc + TP; Anthracyclines plus trastuzumab + pertuzumab followed by taxanes, platinum-based chemotherapy and trastuzumab + pertuzumab; A + T + TP: Anthracyclines + taxanes + trastuzumab + pertuzumab given concurrently; T + TP → A + C +TP; Taxanes plus trastuzumab + pertuzumab followed by anthracyclines, cyclophosphamide and trastuzumab + pertuzumab; T + Pbc + TP: Taxanes, platinum-based chemotherapy, and trastuzumab + pertuzumab; T + TP: taxanes plus trastuzumab + pertuzumab; pCR: Pathological complete response.

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González-Santiago, S., Saura, C., Ciruelos, E. et al. Real-world effectiveness of dual HER2 blockade with pertuzumab and trastuzumab for neoadjuvant treatment of HER2-positive early breast cancer (The NEOPETRA Study). Breast Cancer Res Treat 184, 469–479 (2020). https://doi.org/10.1007/s10549-020-05866-1

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