Abstract：
OBJECTIVE: While adjuvant bisphosphonate use in early breast cancer (EBC) is associated with improvements in breast cancer-specific outcomes, questions remain around optimal bisphosphonate type, dose and scheduling. We evaluated a single zoledronate infusion in a prospective randomised trial.
METHODS: Postmenopausal patients with EBC were randomised to receive a single infusion of zoledronate (4 mg IV) or 6-monthly treatment for 3 years. Outcomes measured were; Quality of Life (QoL; EQ-5D-5L), bisphosphonate-related toxicities, including acute phase reactions (APRs), recurrence-free survival (RFS), bone metastasis-free survival (BMFS) and overall survival (OS).
RESULTS: 211 patients were randomized to either a single infusion (n = 107) or six-monthly treatment (n = 104). After 3 years of follow up there were no significant differences between the arms for QoL and most toxicity endpoints. APRs following zoledronate occurred in 81% (171/211) of patients (77.6% in single infusion arm and 84.6% in the 6-monthly group). While the frequency of APRs decreased over 3 years in the 6-monthly arm, they still remain common. Of 34/104 (32.7%) patients who discontinued zoledronate early in the 6-monthly treatment group, the most common reason was APRs (16/34, 47%). At the 3 year follow up, there were no differences between arms for RFS, BMFS or OS.
CONCLUSIONS: A single infusion of zoledronate was associated with increased patient convenience, less toxicity, and lower rates of treatment discontinuation. Despite the common clinical impression that APRs decrease with time, this was not observed when patients were specifically questioned. While the study is not powered for non-inferiority, longer-term follow-up for confirmation of RFS and OS rates is ongoing.
METHODS: Postmenopausal patients with EBC were randomised to receive a single infusion of zoledronate (4 mg IV) or 6-monthly treatment for 3 years. Outcomes measured were; Quality of Life (QoL; EQ-5D-5L), bisphosphonate-related toxicities, including acute phase reactions (APRs), recurrence-free survival (RFS), bone metastasis-free survival (BMFS) and overall survival (OS).
RESULTS: 211 patients were randomized to either a single infusion (n = 107) or six-monthly treatment (n = 104). After 3 years of follow up there were no significant differences between the arms for QoL and most toxicity endpoints. APRs following zoledronate occurred in 81% (171/211) of patients (77.6% in single infusion arm and 84.6% in the 6-monthly group). While the frequency of APRs decreased over 3 years in the 6-monthly arm, they still remain common. Of 34/104 (32.7%) patients who discontinued zoledronate early in the 6-monthly treatment group, the most common reason was APRs (16/34, 47%). At the 3 year follow up, there were no differences between arms for RFS, BMFS or OS.
CONCLUSIONS: A single infusion of zoledronate was associated with increased patient convenience, less toxicity, and lower rates of treatment discontinuation. Despite the common clinical impression that APRs decrease with time, this was not observed when patients were specifically questioned. While the study is not powered for non-inferiority, longer-term follow-up for confirmation of RFS and OS rates is ongoing.
摘要：
目的：虽然在早期乳腺癌（EBC）中使用双膦酸盐辅助治疗可改善乳腺癌特异性结局，关于最佳双膦酸盐类型的问题仍然存在，剂量和时间安排。我们在一项前瞻性随机试验中评估了单次唑来膦酸盐输注。
方法：绝经后EBC患者随机接受一次唑来膦酸输注（4mgIV）或6个月治疗3年。测量的结果是；生活质量(QoL；EQ-5D-5L)，双膦酸盐相关毒性，包括急性期反应（APRs），无复发生存率（RFS），无骨转移生存率（BMFS）和总生存率（OS）。
结果：211例患者被随机分为单次输注（n=107）或6个月治疗（n=104）。经过3年的随访，QoL和大多数毒性终点之间没有显着差异。81%(171/211)的患者发生唑来膦酸盐后的APRs(单输注臂77.6%,6个月组84.6%)。虽然在6个月的手臂中，APR的频率在3年内有所下降，它们仍然很常见。在6个月治疗组早期停用唑来膦酸的34/104（32.7%）患者中，最常见的原因是APRs（16/34，47%）。在3年的随访中，RFS的武器之间没有差异，BMFS或OS。
结论：单次输注唑来膦酸盐与增加患者便利性相关，毒性较小,和较低的治疗中断率。尽管临床上常见的印象是APRs随时间下降，当特别询问患者时，没有观察到这一点。虽然这项研究没有非劣效性，RFS和OS率确认的长期随访正在进行中.
方法：绝经后EBC患者随机接受一次唑来膦酸输注（4mgIV）或6个月治疗3年。测量的结果是；生活质量(QoL；EQ-5D-5L)，双膦酸盐相关毒性，包括急性期反应（APRs），无复发生存率（RFS），无骨转移生存率（BMFS）和总生存率（OS）。
结果：211例患者被随机分为单次输注（n=107）或6个月治疗（n=104）。经过3年的随访，QoL和大多数毒性终点之间没有显着差异。81%(171/211)的患者发生唑来膦酸盐后的APRs(单输注臂77.6%,6个月组84.6%)。虽然在6个月的手臂中，APR的频率在3年内有所下降，它们仍然很常见。在6个月治疗组早期停用唑来膦酸的34/104（32.7%）患者中，最常见的原因是APRs（16/34，47%）。在3年的随访中，RFS的武器之间没有差异，BMFS或OS。
结论：单次输注唑来膦酸盐与增加患者便利性相关，毒性较小,和较低的治疗中断率。尽管临床上常见的印象是APRs随时间下降，当特别询问患者时，没有观察到这一点。虽然这项研究没有非劣效性，RFS和OS率确认的长期随访正在进行中.
