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De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer

  • Satoru TanakaEmail author
  • Nobuki Matsunami
  • Hirotaka Morishima
  • Naofumi Oda
  • Tsutomu Takashima
  • Satoru Noda
  • Shinichiro Kashiwagi
  • Yukie Tauchi
  • Yuka Asano
  • Kosei Kimura
  • Hiroya Fujioka
  • Risa Terasawa
  • Kanako Kawaguchi
  • Ayana Ikari
  • Takashi Morimoto
  • Shintaro Michishita
  • Toshihiro Kobayashi
  • Junna Sakane
  • Toshikatsu Nitta
  • Nayuko Sato
  • Norihiro Hokimoto
  • Yukihiro Nishida
  • Mitsuhiko Iwamoto
Original Article
  • 118 Downloads

Abstract

Purpose

Neoadjuvant trastuzumab combined with anthracycline and taxane is now considered a standard regimen for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. A less toxic, non-anthracycline regimen has been considered as a treatment option for patients with node-negative small tumors. Estrogen receptor-negative and HER2-positive (pure HER2) tumors are more likely to achieve a pathological complete response (pCR). This study evaluates the activity and safety of neoadjuvant nanoparticle albumin-bound paclitaxel (nab-PTX) plus trastuzumab for pure HER2 breast cancer in patients with low risk of relapse.

Methods

We treated patients with tumors measuring ≤ 3 cm, node-negative, pure HER2 breast cancer using neoadjuvant nab-PTX 260 mg/m2 with trastuzumab every 3 weeks for four cycles. The primary endpoint was the pCR rate. The secondary endpoints included the clinical response rate, disease-free survival, pathologic response rate (defined as pCR or minimal residual invasive disease only in the breast), breast-conserving surgery conversion rate, safety, and disease-free survival. Depending on the pathological findings of surgical specimens, the administration of adjuvant anthracycline could be omitted.

Results

Eighteen patients were enrolled. No patient required dose delays or reductions; none showed disease progression, and all patients underwent surgery as scheduled. Of the 18 patients, 66.7% achieved pCR, and the adjuvant anthracycline regimen was omitted for all patients. The incidence of severe adverse events was quite low.

Conclusion

This less toxic, anthracycline-free regimen appears to be a significantly effective neoadjuvant therapy for patients with pure HER2 breast cancer at low relapse risk.

Keywords

Human epidermal growth factor receptor 2 Estrogen receptor negative Neoadjuvant chemotherapy Nanoparticle albumin-bound paclitaxel Pathological complete response 

Notes

Acknowledgements

We gratefully acknowledge the participating patients, their families, and study investigators for their invaluable contributions. Data from this study were previously presented at the 2016 39th San Antonio Breast Cancer Symposium.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Compliance with Ethical Standards

Conflict of interest

The authors declare no conflicts of interest associated with this manuscript.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Satoru Tanaka
    • 1
    Email author
  • Nobuki Matsunami
    • 2
  • Hirotaka Morishima
    • 2
  • Naofumi Oda
    • 2
  • Tsutomu Takashima
    • 3
  • Satoru Noda
    • 3
  • Shinichiro Kashiwagi
    • 3
  • Yukie Tauchi
    • 3
  • Yuka Asano
    • 3
  • Kosei Kimura
    • 4
  • Hiroya Fujioka
    • 4
  • Risa Terasawa
    • 4
  • Kanako Kawaguchi
    • 4
  • Ayana Ikari
    • 1
  • Takashi Morimoto
    • 5
  • Shintaro Michishita
    • 5
  • Toshihiro Kobayashi
    • 6
  • Junna Sakane
    • 6
  • Toshikatsu Nitta
    • 7
  • Nayuko Sato
    • 8
  • Norihiro Hokimoto
    • 9
  • Yukihiro Nishida
    • 10
  • Mitsuhiko Iwamoto
    • 4
  1. 1.Department of Breast Surgery, National Hospital OrganizationOsakaminami Medical CenterOsakaJapan
  2. 2.Department of Breast SurgeryOsaka Rosai HospitalOsakaJapan
  3. 3.Department of Breast and Endocrine SurgeryOsaka City University Graduate School of MedicineOsakaJapan
  4. 4.Department of Breast and Endocrine SurgeryOsaka Medical College HospitalOsakaJapan
  5. 5.Department of Breast SurgeryYao Municipal HospitalOsakaJapan
  6. 6.Department of Breast SurgeryRed Cross Takatsuki HospitalOsakaJapan
  7. 7.Department of Breast SurgeryShiroyama HospitalOsakaJapan
  8. 8.Department of Breast SurgerySaiseikai Suita HospitalOsakaJapan
  9. 9.Department of SurgeryRed Cross Kochi HospitalKochiJapan
  10. 10.Department of Breast SurgeryNippon Life HospitalOsakaJapan

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