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Mini Oral - Breast cancer, early stage

163MO - Randomized phase II study of eribulin-based neoadjuvant chemotherapy for triple-negative primary breast cancer patients stratified by homologous recombination deficiency status (JBCRG-22)

Date

18 Sep 2020

Session

Mini Oral - Breast cancer, early stage

Topics

Cytotoxic Therapy

Tumour Site

Breast Cancer

Presenters

Hiroko Bando

Citation

Annals of Oncology (2020) 31 (suppl_4): S303-S339. 10.1016/annonc/annonc267

Authors

H. Bando1, N. Masuda2, T. Yamanaka3, T. Kadoya4, M. Takahashi5, S. Nagai6, S. Ohtani7, T. Aruga8, E. Suzuki9, Y. Kikawa10, H. Yasojima2, H. Kasai11, H. Ishiguro12, H. Kawabata13, S. Morita14, H. Haga15, T.R. Kataoka15, R. Uozumi14, S. Ohno16, M. Toi17

Author affiliations

  • 1 Breast And Endocrine Surgery, Faculty Of Medicine, University of Tsukuba, 305-8577 - Tsukuba/JP
  • 2 Department Of Surgery, Breast Oncology, NHO Osaka National Hospital, 540-0006 - Osaka/JP
  • 3 Department Of Breast And Endocrine Surgery, Kanagawa Cancer Center, 241-85 - Yokohama/JP
  • 4 Department Of Breast Surgery, Hiroshima University Hospital, Hiroshima University, 734-0037 - Hiroshima/JP
  • 5 Department Of Breast Surgery, NHO Hokkaido Cancer Center, 003-0804 - Hokkaido/JP
  • 6 Division Of Breast Oncology, Saitama Cancer Center, 362-0806 - Saitama/JP
  • 7 Department Of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 730-8518 - Hiroshima/JP
  • 8 Breast Surgery Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 113-8677 - Tokyo/JP
  • 9 Department Of Breast Surgery, Kyoto University Hospital, 606-8507 - Kyoto/JP
  • 10 Department Of Breast Surgery, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 11 Institute For Advancement Of Clinical And Translational Science, Kyoto University Hospital, 606-8507 - Kyoto/JP
  • 12 Department Of Medical Oncology, International University of Health and Welfare Hospital, 329-2763 - Nasushiobara/JP
  • 13 Department Of Medical Oncology Breast And Endocrine Surgery, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 14 Department Of Biomedical Statistics And Bioinformatics, Kyoto University Graduate School of Medicine, 606-8507 - Kyoto/JP
  • 15 Department Of Diagnostic Pathology, Kyoto University Hospital, 606-8507 - Kyoto/JP
  • 16 Breast Oncology Center, The Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 17 Department Of Breast Surgery, Kyoto University Graduate School of Medicine, 606-8507 - Kyoto/JP
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Abstract 163MO

Background

Eribulin mesylate (Eri) improves survival in patients with metastatic triple negative breast cancer (TNBC) and its toxicity profile differs from that of taxanes or anthracyclines-based regimen (A). We explored Eri-based neoadjuvant regimens for primary TNBC patients stratified by homologous recombination deficiency (HRD) and BRCA1/2 germline status in a prospective randomized phase II study.

Methods

The study enrolled patients with cT1c–T3(<=7 cm), cN0–N1, and M0, TNBC. Patients <65 years old (yo) with HRD+ or BRCA1/2 variant+ cancer were allocated to group A1 (4 cycles of weekly paclitaxel [wP] + carboplatin [Cb] then 4 of A) or A2 (4 cycles of Eri + Cb then 4 of A). Patients >=65 yo, or <65 yo with HRD- were allocated to group B1 (6 cycles of Eri + cyclophosphamide) or B2 (6 cycles of Eri + capecitabine), each with 4 cycles of A for non-responders to the first 4 cycles of Eri-based therapy. Age, tumor size, nodal status and Ki67-LI were stratification factors. Primary endpoint was pCR rate (ypT0-is, ypN0; centrally confirmed). Secondary endpoints were safety, ORR and breast conservation rate (BCR).

Results

The full analysis set comprised data from all 99 patients enrolled (2/2017-1/2019). Characteristics were similar across groups. In B1 and B2, 48.1% and 55.6%, respectively, completed 6 cycles of an Eri-based regimen. The pCR rates in A1, A2, B1and B2 were 65.2%, 45.5%, 18.5% and 18.5%, respectively (Table). No major difference was seen in secondary endpoints, but peripheral neuropathy incidence was 73.9% in A1 versus 31.8%, 22.2%, 25.9% in A2, B1, B2, respectively. Table: 163MO

Patient characteristics and response

Group A1 A2 B1 B2
N 23 22 27 27
Age* 44.0 (28, 64) 47.5 (26, 63) 59.0 (35, 70) 60.0 (37, 70)
Tumor size, mm* 23.0 (13, 60) 26.5 (13, 64) 30.0 (12, 70) 26.0 (12, 92)
cN(+), n (%) 8 (34.8) 8 (36.4) 11 (40.7) 10 (37.0)
Ki67, %* 58.0 (20, 92) 66.2 (36, 90) 51.6 (16, 90) 48.0 (16, 82)
RDI (P / Eri), % 87.1 83.9 87.8 86.2
CpCRypN0,% (90% CI) 65.2 (46.0, 81.4) 45.5 (27.1, 64.7) 18.5 (7.6, 35.1) 18.5 (7.6, 35.1)
ORR, % (95% CI) 95.7 (78.1, 99.9) 86.4 (65.1, 97.1) 59.3 (38.8, 77.6) 70.4 (49.8, 86.2)
BCR, % (95% CI) 26.1 (10.2, 48.4) 54.5 (32.2, 75.6) 29.2 (12.6, 51.1) 40.0 (21.1, 61.3)

* Median (range)

Conclusions

In TNBC patients with HRD+ or BRCA1/2 variant+ (<65 yo), pCR rate was 65% for wP+Cb followed by A and 46% for Eri+Cb followed by A. Neurotoxicity was less frequent with Eri-based regimens, which are feasible in this neoadjuvant setting. Biomarker studies are on-going.

Clinical trial identification

UMIN-CTR: UMIN000023162.

Editorial acknowledgement

Legal entity responsible for the study

Japan Breast Cancer Research Group.

Funding

Japan Breast Cancer Research Group and Eisai Co., Ltd.

Disclosure

H. Bando: Honoraria (self), Outside the submitted work: AstraZeneca; Honoraria (self), Outside the submitted work: Eisai; Honoraria (self), Outside the submitted work: Kyowa Kirin; Honoraria (self), Outside the submitted work: Taiho; Honoraria (self), Outside the submitted work: Chugai; Honoraria (self), Outside the submitted work: Nihon Kayaku; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Novartis. N. Masuda: Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Chugai; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: AstraZeneca; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Pfizer; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Eli Lilly; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Eisai; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Takeda; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Kyowa Kirin; Research grant/Funding (institution), Outside the submitted work: MSD; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Novartis; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Daiichi Sankyo; Advisory/Consultancy, Board of directors: Japan Breast Cancer Research Group Association. T. Yamanaka: Honoraria (self), Outside the submitted work: Eisai; Honoraria (self), Outside the submitted work: Novartis; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: Kyowa Kirin; Honoraria (self), Outside the submitted work: Chugai; Honoraria (self), Outside the submitted work: Daiichi Sankyo. M. Takahashi: Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Outside the submitted work: AstraZeneca; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: Pfizer. S. Nagai: Honoraria (self), Outside the submitted work: Chugai; Honoraria (self), Outside the submitted work: Taiho ; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: Novartis; Honoraria (self), Outside the submitted work: Eisai. S. Ohtani: Honoraria (self), Outside the submitted work: Chugai; Honoraria (self), Outside the submitted work: AstraZeneca; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: Eisai. T. Aruga: Honoraria (self), Outside the submitted work: Eisai. Y. Kikawa: Honoraria (self), Outside the submitted work: Eisai; Honoraria (self), Outside the submitted work: Novartis; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: Taiho; Honoraria (self), Outside the submitted work: Chugai. H. Kasai: Research grant/Funding (institution): Eisai; Honoraria (self), Outside the submitted work: Chugai. H. Kawabata: Research grant/Funding (institution): Chugai; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Daiichi Sankyo. S. Morita: Honoraria (self), Outside the submitted work: AstraZeneca; Honoraria (self), Outside the submitted work: Bristol-Myers Squibb Company; Honoraria (self), Outside the submitted work: Chugai; Honoraria (self), Outside the submitted work: Eisai; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: MSD; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Taiho. R. Uozumi: Honoraria (self), Outside the submitted work: Eisai; Honoraria (self), Outside the submitted work: Sawai; Honoraria (self), Outside the submitted work: CAC Croit.

S. Ohno: Honoraria (self), Outside the submitted work: Chugai; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Eisai; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Taiho; Honoraria (self), Outside the submitted work: AstraZeneca; Honoraria (self), Outside the submitted work: Pfizer; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: Kyowa Kirin; Honoraria (self), Outside the submitted work: Nihon Kayaku. M. Toi: Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Chugai; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Takeda; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Outside the submitted work: Kyowa Kirin; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Taiho; Research grant/Funding (institution), Outside the submitted work: JBCRG association; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Outside the submitted work: Daiichi Sankyo; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: AstraZeneca; Honoraria (self), Outside the submitted work: Eli Lilly; Honoraria (self), Outside the submitted work: MSD; Honoraria (self), Outside the submitted work: Genomic Health; Honoraria (self), Outside the submitted work: Novartis; Honoraria (self), Outside the submitted work: Konica Minolta; Research grant/Funding (institution), Outside the submitted work: Astellas; Honoraria (self), Outside the submitted work: Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Shimadzu; Honoraria (self), Outside the submitted work: Yakult; Honoraria (self), Research grant/Funding (institution), Outside the submitted work: Nihon Kayaku; Research grant/Funding (institution), Outside the submitted work: AFI Technologies; Advisory/Consultancy, Outside the submitted work: Athenex Oncology; Advisory/Consultancy, Board of directors: JBCRG association,; Advisory/Consultancy, Board of directors: Organisation for Oncology and Translational Research; Advisory/Consultancy, Board of directors: Kyoto Breast Cancer Research Network. All other authors have declared no conflicts of interest.

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