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Efficacy and safety of 188Re-HEDP in lung cancer patients with bone metastases: a randomized, multicenter, multiple-dose phase IIa study

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Abstract

Purpose

To investigate the pain-relieving effect and safety of three different doses of 188Re-hydroxyethylidine diphosphonate (HEDP) in patients with lung cancer and bone metastases.

Methods

For this randomised, phase 2 and multicenter trial, we enrolled patients with lung carcinoma and multifocal bone metastases and excluded patients who had received bisphosphonates or external-beam radiotherapy within the previous 4 weeks. Fifty-four patients were randomized to receive a single injection of 188Re-HEDP, at doses of 30, 40 or 50 MBq/kg (interval, 12 weeks). Patients were followed-up by assessment of numerical rating scale (NRS) score, global quality of life (QOL) score and adverse events (AEs). ANOVA analysis, Chi-Squared test and LSD-t test were used in this study.

Results

Significantly decreased NRS scores relative to baseline were observed in 40 MBq/kg group (Week 0 vs. Week 12: 6.0 ± 1.4 vs. 4.8 ± 2.5, P = 0.033) and 50 MBq/kg group (Week 0 vs. Week 12: 5.5 ± 1.5 vs. 4.5 ± 2.9, P = 0.046). Significant change of global QOL score from baseline was observed in 40 MBq/kg group at week 8 (global QOL score: P = 0.024, pain score: P = 0.041) and 50 MBq/kg group (pain score: P = 0.021) at week 12. No patients withdrew trial because of AEs in three groups.

Conclusions

188Re-HEDP at dose of 40 and 50 MBq/kg was generally effective to alleviate pain and improve QOL in lung cancer patients with painful bone metastases. 188Re-HEDP was safe and well-tolerated.

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Acknowledgements

The authors thank all study participants for their great effort.

Funding

This study was supported by the grants from the Ministry of Science and Technology of China (2017YFC0113300), the National Natural Science Fund of China (No. 81571706) and China Scholarship Council (CSC, No. 202006100180).

Author information

Authors and Affiliations

  1. Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing’an District, No.12 Urumchi Middle Road, Shanghai, 200040, China

    Ping Chen, Jun Li, Jicong Gui, Congjin Liu, Yuankai Wang, Guangming Zhang, Dayu Kuai & Xingdang Liu

  2. Department of Nuclear Medicine, The First Affiliated Hospital of Soochow University, Suzhou, China

    Yiwei Wu

  3. Department of Nuclear Medicine, The Second Affiliated Hospital of Soochow University, Suzhou, China

    Zengli Liu

  4. Department of Nuclear Medicine, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, China

    Changjing Zuo

  5. Department of Nuclear Medicine, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, China

    Zhongwei Lv

  6. Department of Nuclear Medicine, Shanghai Cancer Center, Fudan University, Shanghai, China

    Yingjian Biao ZhangLi

  7. Department of Nuclear Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

    Yingjian Biao ZhangLi

  8. Department of Nuclear Medicine, Pudong Hospital, Fudan University, Shanghai, China

    Ping Chen & Xingdang Liu

Authors
  1. Ping Chen
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  2. Jun Li
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  11. Zhongwei Lv
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  12. Yingjian Biao ZhangLi
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  13. Xingdang Liu
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Contributions

Xingdang Liu is corresponding author who was coordinating investigator (COI) in this study. Ping Chen is first author who was co-investigator (CI) in this study. Yiwei Wu, Zengli Liu, Changjing Zuo, Zhongwei Lv, Yingjian Zhang and Biao Li were principal investigator (PI) who screened patients into clinical trial. Jun Li, Jicong Gui, Congjin Liu, Yuankai Wang, Guangming Zhang, Dayu Kuai were sub-investigator (SI) who recorded and analyzed data.

Corresponding author

Correspondence to Xingdang Liu.

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Chen, P., Li, J., Gui, J. et al. Efficacy and safety of 188Re-HEDP in lung cancer patients with bone metastases: a randomized, multicenter, multiple-dose phase IIa study. Int J Clin Oncol 26, 1212–1220 (2021). https://doi.org/10.1007/s10147-021-01906-y

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  • DOI: https://doi.org/10.1007/s10147-021-01906-y

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