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Poster lunch

1656 - The efficacy of eribulin mesylate with trastuzumab for locally advanced or metastatic HER2-positive breast cancer treated with prior pertuzumab and/or T-DM1: results from a Phase II, single arm, multicenter study (N-SOG 10 study). (101P)

Date

18 Nov 2017

Session

Poster lunch

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

Masahiro Fujii

Citation

Annals of Oncology (2017) 28 (suppl_10): x26-x34. 10.1093/annonc/mdx654

Authors

M. Fujii1, N. Tsunoda2, M. Hattori3, T. Murata4, K. Akahane5, K. Kamei6, Y. Goto7, T. Amemiya8, K. Nishimae9, T. Kubota10, Y. Ito11, Y. Kurumiya12, M. Yoshihara13, K. Nakanishi14, T. Kikumori14, M. Ando15, M. Nagino16

Author affiliations

  • 1 Department Of Breast Oncology, Aichi Cancer Center Aichi hospital, 444-0011 - Okazaki/JP
  • 2 Division Of Surgical Oncology, Department Of Surgery, Nagoya University, Graduate School of Medicine, 466-8550 - Nagoya/JP
  • 3 1. department Of Breast Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 4 Department Of Breast Oncology, Aichi Cancer Center, 444-0011 - okazaki/JP
  • 5 Department Of Surgery, Japanese Red Cross Nagoya Daini Hospital, 466-8650 - nagoya/JP
  • 6 Department Of Surgery, Ogaki Municipal Hospital, 503-8502 - oogaki/JP
  • 7 Department Of Surgery, Japanese Red Cross Nagoya Daiichi Hospital, 453-8511 - nagoya/JP
  • 8 Department Of Surgery, Anjo Kosei Hospital, 446-8602 - anjo/JP
  • 9 Department Of Surgery, Shizuoka General Hospital, 422-8527 - shizuoka/JP
  • 10 Department Of Breast Surgery, Kamiiida Daiichi General Hospital, 462-0802 - nagoya/JP
  • 11 Department Of Surgery, Chukyo Hospital, 457-8510 - nagoya/JP
  • 12 Department Of Surgery, Toyota Kosei Hospital, 470-0396 - toyota/JP
  • 13 Department Of Surgery, Toyohashi Municipal Hospital, 441-8570 - toyohashi/JP
  • 14 Department Of Breast And Endocrine Surgery, Nagoya University Hospital, 466-8550 - Nagoya/JP
  • 15 Center For Advanced Medicine And Clinical Research, Nagoya University Hospital, 466-8550 - Nagoya/JP
  • 16 Division Of Surgical Oncology, Department Of Surgery, Nagoya University Graduate School of Medicine, 466-8550 - Nagoya/JP
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Resources

Abstract 1656

Background

Eribulin mesylate (ERI) demonstrated a survival benefit in patients with locally recurrent or metastatic breast cancer who previously received 2 or more chemotherapy regimens. Recently, we conducted Phase II study about the efficacy of ERI with trastuzumab (ERI+TRA) as late-line therapy for locally advanced or metastatic HER2-positive breast cancer (UMIN000012350), and reported that objective response rate (ORR) and median progression-free survival (mPFS) were 17% and 4.6 months. However, some patients who received prior pertuzumab (PER) and/or T-DM1 were enrolled in that study, there are limited data on the efficacy of ERI+TRA in those patients. The aim of this study was to assess the efficacy of this combination therapy based on prior PER and/or T-DM1 use.

Methods

In primary phase II study, patients with locally advanced or metastatic HER2 positive breast cancer who previously received at least one chemotherapeutic regimen, received ERI at 1.4 mg/m2 intravenously (I.V.) on days 1 and 8 of each 21-day cycle with an initial TRA dose of 8 mg/kg I.V. on day 1, followed by 6 mg/kg of TRA on day 1 of each subsequent cycle. ORR, clinical benefit rate (CBR) and PFS were assessed in patients who had and had not received prior PER and/or T-DM1.

Results

Thirty-six patients (median age: 60.5 years) received ERI+TRA. 69.4% (n = 25) had previously treated with prior PER and/or T-DM1, defined as ‘prior’ patients. Remaining 30.6% (n = 11) without both agents were defined as ‘non-prior’ patients. In prior patients compared with non-prior patients, median number of prior treatment regimens was 4 (range, 1‐8) versus 3 (range, 1-7), respectively; ORR was 12.0% versus 27.3%, respectively; CBR was 24.0% versus 54.5%, respectively; mPFS was 4.3 versus 9.7 months, respectively.

Conclusions

ERI+TRA demonstrated lower efficacy than in non-prior patients, but CBR and PFS were 24.0% and 4.3 months, which was considered to be a clinically relevant treatment option in patients who received prior PER and/or T-DM1.

Clinical trial identification

UMIN000012350.

Legal entity responsible for the study

Nagoya Surgical Oncology Group

Funding

Eisai

Disclosure

All authors have declared no conflicts of interest.

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