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Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial

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Abstract

Background and purpose

Fulvestrant, an oestrogen receptor (ER) antagonist with no known agonist effects, has shown activity in postmenopausal patients with ER-positive advanced breast cancer recurring or progressing following prior endocrine therapy. This double-blind, double-dummy, randomised phase III study (NCT00327769) was designed to compare the efficacy and safety of fulvestrant versus anastrozole in advanced breast cancer of Chinese postmenopausal women whose disease has progressed following prior endocrine treatment.

Materials and methods

A total of 234 patients were randomised to fulvestrant 250 mg/month (n = 121) or 1 mg/day anastrozole (n = 113), together with matching placebo. The primary endpoint was time to progression (TTP). Secondary endpoints included objective response rate (ORR), duration of response (DoR), clinical benefit rate (CBR) and time to treatment failure (TTF).

Results

Baseline characteristics were similar, with the possible exception that a higher number of fulvestrant patients had received two prior chemotherapy regimens. Median TTP was 110 days in the fulvestrant group versus 159 days in the anastrozole group (hazard ratio [HR], 1.314; 95% confidence intervals [CI], 0.948, 1.822; P = 0.101). ORR was 10% in the fulvestrant group and 14% in the anastrozole group. Median DoR from randomisation to progression was 436 days versus 432 days for the fulvestrant and anastrozole groups, respectively. CBR for fulvestrant (36.1%) versus anastrozole (48.2%) was not statistically different between the groups. TTF (110 days versus 147 days for the fulvestrant and anastrozole groups, respectively) was not statistically different between the treatments (HR, 1.307; 95% CI, 0.961, 1.778; P = 0.088). Both treatments were well tolerated, with only two patients treated with fulvestrant and four patients treated with anastrozole withdrawn from study treatment due to adverse events.

Conclusions

These data demonstrate that fulvestrant 250 mg and anastrozole were similarly effective and well tolerated in the treatment of postmenopausal Chinese women with advanced breast cancer whose disease had progressed or recurred on prior endocrine treatment.

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Acknowledgments

We thank Simon Vass, PhD, from Complete Medical Communications who provided medical writing support funded by AstraZeneca. We also thank Dr. Tao Huang (Union Hospital, Huazhong Science and Technique University), Dr. Jun Ren (Cancer Hospital, Peking University), Dr. Gang Cheng (Beijing Hospital), Dr. Jiwei Liu (First Affiliated Hospital, Dalian Medical University), Dr. Chunkang Yang and Dr. Jianxin Ye (First Affiliated Hospital, Fujian Medical Unversity), Dr. Ning Liao (Guandong Province Hospital), Dr. Wenchao Liu (Xijing Hospital) and Dr. Shukui Qin (Nanjing Bayi Hospital) for their dedication to this study.

Conflict of interest

Binghe Xu, Zefei Jiang, Zhimin Shao, Jiayu Wang, Jifeng Feng, Shuping Song, Zhendong Chen, Kangsheng Gu, Shiying Yu, Yiping Zhang, Chuan Wang, Fengchun Zhang, Junlan Yang have nothing to declare.

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Authors and Affiliations

  1. Department of Medical Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuan Nanli, Chaoyang District, 100021, Beijing, China

    Binghe Xu & Jiayu Wang

  2. Beijing 307 Hospital, Beijing, China

    Zefei Jiang

  3. Cancer Hospital and Shanghai Cancer Institute, Fudan University, Shanghai, China

    Zhimin Shao

  4. Jiangsu Cancer Hospital, Nanjing, China

    Jifeng Feng

  5. Shandong Cancer Hospital, Jinan, China

    Shuping Song

  6. First Affiliated Hospital, Anhui Medical University, Hefei, China

    Zhendong Chen & Kangsheng Gu

  7. Tongji Hospital, Huizhong Science and Technique University, Wuhan, China

    Shiying Yu

  8. Zhejiang Cancer Hospital, Hangzhou, China

    Yiping Zhang

  9. Affiliated Union Hospital, Fujian Medical University, Fuzhou, China

    Chuan Wang

  10. Renji Hospital, Shanghai Jiaotong University, Shanghai, China

    Fengchun Zhang

  11. 301 Hospital, Beijing, China

    Junlan Yang

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  1. Binghe Xu
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Correspondence to Binghe Xu.

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Xu, B., Jiang, Z., Shao, Z. et al. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol 67, 223–230 (2011). https://doi.org/10.1007/s00280-010-1483-x

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  • DOI: https://doi.org/10.1007/s00280-010-1483-x

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