4.3 Article

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

期刊

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY
卷 26, 期 7, 页码 1212-1220

出版社

SPRINGER JAPAN KK
DOI: 10.1007/s10147-021-01906-y

关键词

Re-188-HEDP; Bone metastases; Lung cancer

类别

资金

  1. Ministry of Science and Technology of China [2017YFC0113300]
  2. National Natural Science Fund of China [81571706]
  3. China Scholarship Council (CSC) [202006100180]

向作者/读者索取更多资源

The study demonstrated that a dose of 40 and 50 MBq/kg of Re-188-HEDP was effective in alleviating pain and improving QOL in lung cancer patients with bone metastases, and it was safe and well-tolerated by the patients.
Purpose To investigate the pain-relieving effect and safety of three different doses of Re-188-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 Re-188-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 Re-188-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. Re-188-HEDP was safe and well-tolerated.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.3
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据