医学
唑来膦酸
乳腺癌
骨转移
骨痛
不利影响
止痛药
骨重建
泌尿科
内科学
临床终点
随机对照试验
癌症
肿瘤科
外科
麻醉
作者
Kimito Yamada,Hiroshi Kaise,Tetsuya Taguchi,Jun Horiguchi,Shintaro Takao,Masato Suzuki,Tomoyuki Kubota,Daishu Miura,Kazutaka Narui,Kanae Tawaraya,Yurika Machida,Kohei Akazawa,Norio Kohno,Takashi Ishikawa
标识
DOI:10.1007/s00774-022-01366-y
摘要
Introductionβ-ray strontium-89 (Sr-89) intra-irradiation therapy has been approved and clinically used to reduce bone metastasis pain not alleviated by bone-modifying agents, external radiation, and analgesic agents. We examined the efficacy of zoledronic acid (ZOL) and Sr-89 combination therapy compared with ZOL alone in breast cancer patients with bone metastases.Materials and methodsA randomized controlled trial was conducted on breast cancer patients with bone metastasis to compare the efficacy between ZOL monotherapy and ZOL plus Sr-89 combination therapy. The primary endpoints were changes in urinary NTX levels at 13 weeks and brief pain inventory scores. The secondary endpoints were analgesic drug usages, response rates, changes in bone metabolism markers, quality of life, and adverse event rates.ResultsThirty of the planned 60 cases were randomly assigned to ZOL alone or ZOL + Sr-89. There were no significant differences in the changes in urinary NTX levels between the 2 groups (P = 0.365). There was no consistent difference in the pain score changes between the 2 groups. Sr-89 addition to ZOL slightly reduced the white blood cell and platelet counts. However, all adverse events were Grade 1. Safety and analgesic drug dose reduction were more evident in ZOL + Sr-89.ConclusionThis trial showed the lack of benefits from Sr-89 addition to ZOL for breast cancer patients with painful bone metastases. However, safety and analgesic drug dose reduction were more evident in ZOL + Sr-89, indicating its potential for pain control. Sr-89 therapy is safe, thus more effective radiopharmaceuticals are anticipated.
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