Kimito Yamada1,2, Hiroshi Kaise3,4, Tetsuya Taguchi5, Jun Horiguchi6, Shintaro Takao7, Masato Suzuki8, Tomoyuki Kubota9, Daishu Miura10, Kazutaka Narui11, Kanae Tawaraya12, Yurika Machida13, Kouhei Akazawa13, Norio Kohno14, Takashi Ishikawa3. 1. Department of Breast Oncology and Surgery, Tokyo Medical University Hospital, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. toya0@tokyo-med.ac.jp. 2. Department of Breast surgery, Tokyo Medical University, Hachioji Medical Center, Tokyo, Japan. toya0@tokyo-med.ac.jp. 3. Department of Breast Oncology and Surgery, Tokyo Medical University Hospital, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. 4. Department of Breast Surgery, Tokyo Medical University, Ibaraki Medical Center, Ibaraki, Japan. 5. Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan. 6. Department of Breast Surgery, International University of Health and Welfare, Chiba, Japan. 7. Department of Breast Surgery, Hyogo Cancer Center, Hyogo, Japan. 8. Department of Surgery, National Hospital Organization Chiba Medical Center, Chiba, Japan. 9. Department of Surgery, Kamiiida Daiichi General Hospital, Aichi, Japan. 10. Akasaka Miura Clinic, Tokyo, Japan. 11. Department of Breast and Endocrine Surgery, Yokohama City University Medical Center, Kanagawa, Japan. 12. Yokohama Sakae Kyosai Hospital, Yokohama, Japan. 13. Department of Medical Informatics, Niigata University Medical and Dental Hospital, Niigata, Japan. 14. Department of Breast Surgery, Kobe Kaisei Hospital, Hyogo, Japan.
Abstract
INTRODUCTION: β-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 METHODS: A 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. RESULTS: Thirty 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. CONCLUSION: This 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.
INTRODUCTION: β-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 METHODS: A 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. RESULTS: Thirty 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. CONCLUSION: This 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.