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Patterns of Use of Docetaxel-Containing Adjuvant Chemotherapy Among Chinese Patients with Operable Breast Cancer: A Multicenter Observational Study

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Abstract

Introduction

Adjuvant docetaxel-based chemotherapy is frequently used in the treatment of operable early breast cancer (EBC). This study investigated patterns of docetaxel use in patients with EBC in real-world clinical practice in China.

Methods

This was a multicenter, prospective, observational study of Chinese women with operable breast cancer in tier 1 non-oncology-specific hospitals and other city hospitals in China. Adult Chinese female patients (≥ 18 years) with newly diagnosed breast cancer who underwent surgery and received docetaxel-containing adjuvant chemotherapy were eligible for inclusion. The primary end point of the study was to assess patterns of docetaxel use for adjuvant therapy in Chinese clinical practice. Secondary end points included factors associated with treatment selection, patterns of G-CSF use and safety.

Results

In total, 502 patients were enrolled, 475 of whom were included in the analysis. The results showed that 31.6% of patients received docetaxel and anthracyclines in combination, 47.2% received docetaxel and anthracyclines sequentially, 18.5% received docetaxel and other medication either in combination or sequentially and 2.7% received ‘other’ chemotherapy regimens. Factors influencing selection of docetaxel/anthracycline in combination versus sequentially included age, breast cancer subgroup, PR status, and preoperative neoadjuvant chemotherapy. A total of 258 (54.3%), 35 (7.4%), and 108 (22.7%) patients received G-CSF as primary prevention, secondary prevention and treatment, respectively. Treatment-emergent adverse events (TEAEs) occurred in 54.5% (259) of patients, and the most frequently reported TEAEs (≥ 5% of patients) included bone marrow failure (10.1%), granulocytopenia (9.9%), nausea (8.8%) and vomiting (6.9%). Neutropenia and febrile neutropenia were reported by 10 and 12 patients, respectively.

Conclusion

Docetaxel for adjuvant chemotherapy of operable EBC in China was most commonly given in combination or sequentially with anthracyclines. The study also showed that in China G-CSF is most frequently used as primary prophylactic, and no unexpected safety events were observed during docetaxel treatment.

Funding

Sanofi (China).

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Acknowledgements

We thank all study participants and their families as well as all of the investigators.

Funding

This study was sponsored by Sanofi (China). The publication fees for this manuscript were funded by Sanofi. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Editorial Assistance

Editorial assistance for this manuscript was funded by Sanofi and provided by Tigermed and Rude Health Consulting.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole and have given their approval for this version to be published.

Disclosures

Hui Xie, Jinping Liu, Shiyou Yu, Yiding Chen, Min Zheng, Yongchuan Deng, Shu Wang, Jun Jiang, Yafen Li, Huiping Li, Hua Kang, Chunhui Zhang, Guo-Jun Zhang, Fengxi Su, Aiqun Cheng and Shui Wang have nothing to disclose.

Compliance with Ethics Guidelines

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Data Availability

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan and data set specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of our trial participants. Further details on Sanofi’s data sharing criteria, eligible studies and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/.

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Authors and Affiliations

  1. Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University), Nanjing, China

    Hui Xie & Shui Wang

  2. Sichuan Provincial People’s Hospital, Sichuan Medical Science Academy, Chengdu, China

    Jinping Liu

  3. Suzhou Municipal Hospital, Suzhou, China

    Shiyou Yu

  4. Women’s Hospital School of Medicine, Zhejiang University, Hangzhou, China

    Yiding Chen

  5. Second Affiliated Hospital Wen Zhou Medical College, Wenzhou, China

    Min Zheng

  6. Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China

    Yongchuan Deng

  7. People’s Hospital Peking University, Beijing, China

    Shu Wang

  8. Southwest Hospital, Army Medical University, Chongqing, China

    Jun Jiang

  9. Shanghai Ruijin Hospital, College of Medicine, Shanghai Jiao Tong University, Shanghai, China

    Yafen Li

  10. Peking University Cancer Hospital, Beijing, China

    Huiping Li

  11. Xuanwu Hospital Capital Medical University, Beijing, China

    Hua Kang

  12. Affiliated Hospital of Nantong University, Nantong, China

    Chunhui Zhang

  13. Cancer Hospital of Shantou University Medical College, Shantou, China

    Guo-Jun Zhang

  14. Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China

    Fengxi Su

  15. Huadong Hospital Affiliated to Fudan University, Shanghai, China

    Aiqun Cheng

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  1. Hui Xie
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Correspondence to Shui Wang.

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Xie, H., Liu, J., Yu, S. et al. Patterns of Use of Docetaxel-Containing Adjuvant Chemotherapy Among Chinese Patients with Operable Breast Cancer: A Multicenter Observational Study. Adv Ther 36, 131–146 (2019). https://doi.org/10.1007/s12325-018-0841-7

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