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Title: Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial.
Author: Lipplaa A, Kroep JR, van der Heijden L, Jutte PC, Hogendoorn PCW, Dijkstra S, Gelderblom H.
Journal: Oncologist; 2019 Jul; 24(7):889-e421. PubMed ID: 31040253.
Abstract:
LESSONS LEARNED: Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of giant cell tumor of bone (GCTB) in this study. The efficacy could not be determined because of the small sample size.GCTB recurrences, even in the denosumab era, are still an issue; therefore, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid. BACKGROUND: Bisphosphonates are assumed to inhibit giant cell tumor of bone (GCTB)-associated osteoclast activity and have an apoptotic effect on the neoplastic mononuclear cell population. The primary objective of this study was to determine the 2-year recurrence rate of high-risk GCTB after adjuvant zoledronic acid versus standard care. METHODS: In this multicenter randomized open-label phase II trial, patients with high-risk GCTB were included (December 2008 to October 2013). Recruitment was stopped because of low accrual after the introduction of denosumab. In the intervention group, patients received adjuvant zoledronic acid (4 mg) intravenously at 1, 2, 3, 6, 9, and 12 months after surgery. RESULTS: Fourteen patients were included (intervention n = 8, controls n = 6). Median follow-up was long: 93.5 months (range, 48-111). Overall 2-year recurrence rate was 38% (3/8) in the intervention versus 17% (1/6) in the control group (p = .58). All recurrences were seen within the first 15 months after surgery. CONCLUSION: Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of GCTB in this study. The efficacy could not be determined because of the small sample size. Because recurrences, even in the denosumab era, are still an issue, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid. 经验总结: 在本研究中，唑来膦酸辅助治疗未能降低骨巨细胞瘤 (GCTB) 的复发率。由于样本量小，无法确定疗效。. 即使是Denosumab 治疗时代，仍存在 GCTB 复发问题，因此，探讨唑来膦酸辅助治疗 GCTB 的有效性随机研究仍然需要。. 摘要 背景。双膦酸盐被认为可以抑制骨巨细胞瘤 (GCTB) 相关的破骨细胞活性，诱导肿瘤单核细胞群凋亡。本研究的主要目的是确定唑来膦酸辅助治疗与标准治疗对于高风险 GCTB 2 年复发率的影响。方法。本项多中心随机开放标签 II 期试验的研究对象为高风险 GCTB 患者(2008 年 12 月至 2013 年 10 月)。Denosumab治疗出现后，由于入组率较低，停止了研究对象的招募。干预组患者于术后 1、2、3、6、9、12 个月后静脉注射唑来膦酸(4mg)辅助治疗。结果。入组了 14 例患者(干预组 n = 8，对照组 n = 6)。随访时间较长，平均为:93.5 个月(范围:48–111个月)。干预组整体 2 年内复发率为 38% (3/8)，对照组为 17% (1/6) (p = 0.58)。复发病情皆发生于术后 15 个月内。结论。在本研究中，唑来膦酸辅助治疗未能降低 GCTB 的复发率。由于样本量小，无法确定疗效。即使是使用Denosumab治疗，仍存在 GCTB 复发问题，因此，探讨唑来膦酸辅助治疗 GCTB 的有效性随机研究仍然需要。

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