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Erschienen in: Cancer Chemotherapy and Pharmacology 6/2019

08.04.2019 | Original Article

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

verfasst von: Satoru Tanaka, 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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 6/2019

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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.
Literatur
1.
Zurück zum Zitat Hudis CA (2007) Trastuzumab—mechanism of action and use in clinical practice. N Engl J Med 357:39–51CrossRef Hudis CA (2007) Trastuzumab—mechanism of action and use in clinical practice. N Engl J Med 357:39–51CrossRef
2.
Zurück zum Zitat Buzdar AU, Valero V, Ibrahim NK et al (2007) Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: an update of the initial randomized study population and data of additional patients treated with the same regimen. Clin Cancer Res 13:228–233CrossRef Buzdar AU, Valero V, Ibrahim NK et al (2007) Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: an update of the initial randomized study population and data of additional patients treated with the same regimen. Clin Cancer Res 13:228–233CrossRef
3.
Zurück zum Zitat Gianni L, Eiermann W, Semiglazov V et al (2010) Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 375:377–384. https://doi.org/10.1016/S0140-6736(09)61964-4 CrossRefPubMed Gianni L, Eiermann W, Semiglazov V et al (2010) Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 375:377–384. https://​doi.​org/​10.​1016/​S0140-6736(09)61964-4 CrossRefPubMed
4.
Zurück zum Zitat Suter TM, Procter M, van Veldhuisen DJ et al (2007) Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol 25:3859–3865CrossRef Suter TM, Procter M, van Veldhuisen DJ et al (2007) Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol 25:3859–3865CrossRef
7.
Zurück zum Zitat Pegram MD, Lopez A, Konecny G, Slamon DJ (2000) Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin Oncol 27:21–25; discussion 92–100 Pegram MD, Lopez A, Konecny G, Slamon DJ (2000) Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin Oncol 27:21–25; discussion 92–100
8.
Zurück zum Zitat Inoue K, Nakagami K, Mizutani M (2010) Randomized phase III trial of trastuzumab monotherapy followed by trastuzumab plus docetaxel versus trastuzumab plus docetaxel as first-line therapy in patients with HER2-positive metastatic breast cancer: the JO17360 trial group. Breast Cancer Res Treat 119:127–136. https://doi.org/10.1007/s10549-009-0498-7 CrossRefPubMed Inoue K, Nakagami K, Mizutani M (2010) Randomized phase III trial of trastuzumab monotherapy followed by trastuzumab plus docetaxel versus trastuzumab plus docetaxel as first-line therapy in patients with HER2-positive metastatic breast cancer: the JO17360 trial group. Breast Cancer Res Treat 119:127–136. https://​doi.​org/​10.​1007/​s10549-009-0498-7 CrossRefPubMed
10.
Zurück zum Zitat Untch M, Jackisch C, Schneeweiss A et al (2016) Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol 17:345–356CrossRef Untch M, Jackisch C, Schneeweiss A et al (2016) Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol 17:345–356CrossRef
15.
Zurück zum Zitat Buzdar AU, Suman VJ, Meric-Bernstam F et al (2013) Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol 14:1317–1325. https://doi.org/10.1016/S1470-2045(13)70502-3 CrossRefPubMedPubMedCentral Buzdar AU, Suman VJ, Meric-Bernstam F et al (2013) Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol 14:1317–1325. https://​doi.​org/​10.​1016/​S1470-2045(13)70502-3 CrossRefPubMedPubMedCentral
16.
Zurück zum Zitat Romond EH, Perez EA, Bryant J et al (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353:1673–1684CrossRef Romond EH, Perez EA, Bryant J et al (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353:1673–1684CrossRef
23.
Zurück zum Zitat Nitz UA, Gluz O, Christgen M et al (2017) De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab ± weekly paclitaxel. Ann Oncol 28:2768–2772. https://doi.org/10.1093/annonc/mdx494 CrossRefPubMed Nitz UA, Gluz O, Christgen M et al (2017) De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab ± weekly paclitaxel. Ann Oncol 28:2768–2772. https://​doi.​org/​10.​1093/​annonc/​mdx494 CrossRefPubMed
24.
Metadaten
Titel
De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer
verfasst von
Satoru Tanaka
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
Publikationsdatum
08.04.2019
Verlag
Springer Berlin Heidelberg
Erschienen in
Cancer Chemotherapy and Pharmacology / Ausgabe 6/2019
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-019-03836-z

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