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Published in: Breast Cancer Research and Treatment 2/2023

Open Access 31-03-2023 | Breast Cancer | Clinical trial

Fulvestrant plus palbociclib in advanced or metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer after fulvestrant monotherapy: Japan Breast Cancer Research Group-M07 (FUTURE trial)

Authors: Kenichi Watanabe, Naoki Niikura, Yuichiro Kikawa, Mari Oba, Kokoro Kobayashi, Hiroshi Tada, Shinji Ozaki, Uhi Toh, Yutaka Yamamoto, Michiko Tsuneizumi, Toshitaka Okuno, Nobutaka Iwakuma, Takashi Takeshita, Takayuki Iwamoto, Hiroshi Ishiguro, Norikazu Masuda, Shigehira Saji

Published in: Breast Cancer Research and Treatment | Issue 2/2023

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Abstract

Purpose

The combination of cyclin-dependent kinase 4/6 inhibitors and endocrine therapy is a standard treatment for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC); however, their toxicities and financial burden are major issues, especially for prolonged treatment. We investigated fulvestrant plus palbociclib in patients with HR-positive MBC resistant to fulvestrant monotherapy.

Methods

Patients who initially received fulvestrant as their first- or second-line endocrine therapy were assigned to group A. Patients with disease progression during fulvestrant monotherapy who subsequently received fulvestrant plus palbociclib were assigned to group B. The primary endpoint was progression-free survival (PFS1) in group B. We set the threshold median PFS of 5 months (null hypothesis).

Results

Between January 2018 and February 2020 we enrolled 167 patients in group A (January 2018–February 2020) from 55 institutions, of whom 72 subsequently received fulvestrant plus palbociclib and were enrolled in group B. The median follow-up was 23.8 and 8.9 months in groups A and B, respectively. The median PFS in group B (combination therapy) was 9.4 (90% confidence interval [CI]: 6.9–11.2) months (p < 0.001). This was 25.7 (90% CI: 21.2–30.3) months in group A (fulvestrant monotherapy). The TTF in group B was 7.2 (90% CI: 5.5–10.4) months. In the post-hoc analysis, the median PFS1 in group B among patients with longer-duration fulvestrant monotherapy (> 1 year) was longer than that of patients with shorter-duration monotherapy (≤ 1 year) (11.3 vs. 7.6 months). No new toxicities were observed.

Conclusion

Our findings suggest that palbociclib plus fulvestrant after disease progression despite fulvestrant monotherapy is potentially safe and effective in patients with HR-positive/HER2-negative advanced MBC.
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Metadata
Title
Fulvestrant plus palbociclib in advanced or metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer after fulvestrant monotherapy: Japan Breast Cancer Research Group-M07 (FUTURE trial)
Authors
Kenichi Watanabe
Naoki Niikura
Yuichiro Kikawa
Mari Oba
Kokoro Kobayashi
Hiroshi Tada
Shinji Ozaki
Uhi Toh
Yutaka Yamamoto
Michiko Tsuneizumi
Toshitaka Okuno
Nobutaka Iwakuma
Takashi Takeshita
Takayuki Iwamoto
Hiroshi Ishiguro
Norikazu Masuda
Shigehira Saji
Publication date
31-03-2023
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 2/2023
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-023-06911-5

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