Ping Chen1,2, Jun Li1, Jicong Gui1, Congjin Liu1, Yuankai Wang1, Guangming Zhang1, Dayu Kuai1, Yiwei Wu3, Zengli Liu4, Changjing Zuo5, Zhongwei Lv6, Yingjian Biao ZhangLi7,8, Xingdang Liu9,10. 1. Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China. 2. Department of Nuclear Medicine, Pudong Hospital, Fudan University, Shanghai, China. 3. Department of Nuclear Medicine, The First Affiliated Hospital of Soochow University, Suzhou, China. 4. Department of Nuclear Medicine, The Second Affiliated Hospital of Soochow University, Suzhou, China. 5. Department of Nuclear Medicine, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, China. 6. Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China. 7. Department of Nuclear Medicine, Shanghai Cancer Center, Fudan University, Shanghai, China. 8. Department of Nuclear Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 9. Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China. xingdliu@fudan.edu.cn. 10. Department of Nuclear Medicine, Pudong Hospital, Fudan University, Shanghai, China. xingdliu@fudan.edu.cn.
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 receivedbisphosphonates or external-beam radiotherapywithin 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.
RCT Entities:
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 cancerpatients with painful bone metastases. 188Re-HEDP was safe and well-tolerated.
Entities:
Keywords:
188Re-HEDP; Bone metastases; Lung cancer
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