Progression-free survival results in postmenopausal Asian women: subgroup analysis from a phase III randomized trial of fulvestrant 500 mg vs anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON)

  • Shinzaburo Noguchi
  • Matthew J. Ellis
  • John F. R. Robertson
  • Jackie Thirlwell
  • Mehdi Fazal
  • Zhimin Shao
Original Article
  • 6 Downloads

Abstract

Background

The international, phase III FALCON study (NCT01602380) in postmenopausal patients with hormone receptor-positive, locally advanced/metastatic breast cancer (LA/MBC) who had not received prior endocrine therapy, demonstrated statistically significant improvement in progression-free survival (PFS) for patients who received fulvestrant 500 mg vs anastrozole 1 mg. This subgroup analysis evaluated PFS in Asian (randomized in China, Japan, or Taiwan) and non-Asian patients from the FALCON study.

Methods

Eligible patients (estrogen receptor- and/or progesterone receptor-positive LA/MBC; World Health Organization performance status 0–2; ≥ 1 measurable/non-measurable lesion[s]) were randomized. PFS was assessed via Response Evaluation Criteria in Solid Tumours version 1.1, surgery/radiotherapy for disease worsening, or death (any cause). Secondary endpoints included: objective response rate, clinical benefit rate, duration of response, and duration of clinical benefit. Consistency of effect across subgroups was assessed via hazard ratios and 95% confidence intervals (CIs) using a log-rank test. Adverse events (AEs) were evaluated.

Results

Of the 462 randomized patients, the Asian and non-Asian subgroups comprised 67 and 395 patients, respectively. In the Asian subgroup, median PFS was 16.6 and 15.9 months with fulvestrant and anastrozole, respectively (hazard ratio 0.81; 95% CI 0.44–1.50). In the non-Asian subgroup, median PFS was 16.5 and 13.8 months, respectively (hazard ratio 0.79; 95% CI 0.62–1.01). Secondary outcomes were numerically improved with fulvestrant vs anastrozole in both subgroups. AE profiles were generally consistent between Asian and non-Asian subgroups.

Conclusions

Results of this subgroup analysis suggest that treatment effects in the Asian patient subgroup are broadly consistent with the non-Asian population.

Keywords

Asian Anastrozole Fulvestrant Progression-free survival Safety 

Notes

Acknowledgements

The authors wish to thank Lynda M. Grinsted for her contribution to the statistical analysis of these data. Medical writing support, funded by AstraZeneca, was provided by Laura Fullerton-Batten of Complete Medical Communications.

Compliance with ethical standards

Ethical approval

The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation, and Good Clinical Practice Guidelines. An ethics committee or institutional review board approved the final protocol at each study site.

Informed consent

All patients provided written, informed consent.

Conflict of interest

Shinzaburo Noguchi has been an advisor for Taiho, and has received research funding from AstraZeneca, Novartis, Chugai, Daiichi-Sankyo, Takeda, Pfizer, Ono, Taiho, and Eisai, and honoraria from AstraZeneca, Novartis, and Chugai. Matthew J. Ellis holds stock and has a leadership position with Bioclassifier LLC, which derives royalties and other income from a sublicense to Nanostring LLC for PAM50-based diagnostics, including Prosigna; he has been an ad hoc consultant for, and received honoraria and research funding from, AstraZeneca, and has also been a consultant for Pfizer, Puma and Novartis. John F. R. Robertson has been a consultant for, and has received honoraria from, AstraZeneca and Bayer AG, has received research funding from AstraZeneca, Bayer AG, and Novartis, has provided expert testimony for AstraZeneca, holds stocks or other ownership with Oncimmune, and holds stock options with Carrick Therapeutics. Jackie Thirlwell is an employee of JMT Statistics Ltd, and is under contract to provide statistical support to AstraZeneca. Mehdi Fazal is an employee of AstraZeneca. Zhimin Shao has no conflicts of interest to disclose.

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Copyright information

© The Japanese Breast Cancer Society 2018

Authors and Affiliations

  • Shinzaburo Noguchi
    • 1
  • Matthew J. Ellis
    • 2
  • John F. R. Robertson
    • 3
  • Jackie Thirlwell
    • 4
  • Mehdi Fazal
    • 5
  • Zhimin Shao
    • 6
  1. 1.Department of Breast and Endocrine SurgeryOsaka University Graduate School of MedicineOsakaJapan
  2. 2.Lester and Sue Smith Breast Center, Baylor Clinic, Baylor College of MedicineHoustonUSA
  3. 3.Division of Medical Sciences and Graduate Entry MedicineUniversity of Nottingham, Royal Derby Hospital CentreDerbyUK
  4. 4.AstraZenecaCambridgeUK
  5. 5.AstraZenecaGaithersburgUSA
  6. 6.Fudan University Shanghai Cancer CenterShanghaiChina

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