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

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.

• Authors: Ping Chen, Jun Li, Jicong Gui, Congjin Liu, Yuankai Wang, Guangming Zhang, Dayu Kuai, Yiwei Wu, Zengli Liu, Changjing Zuo, Zhongwei Lv, Yingjian Biao ZhangLi, Xingdang Liu
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 26 Issue 7 Pg. 1212-1220 (Jul 2021) ISSN: 1437-7772 [Electronic] Japan
• PMID: 33847856 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Organometallic Compounds
• Etidronic Acid

Topics

• Bone Neoplasms (drug therapy, radiotherapy)
• Etidronic Acid
• Humans
• Lung Neoplasms (drug therapy, radiotherapy)
• Male
• Organometallic Compounds
• Palliative Care
• Prostatic Neoplasms
• Quality of Life