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挪威骨巨细胞瘤患者使用地诺单抗:一项全国性队列研究结果

Denosumab in patients with giant-cell tumor of bone in Norway: results from a nationwide cohort.

作者信息

Boye Kjetil, Jebsen Nina Louise, Zaikova Olga, Knobel Heidi, Løndalen Ayca M, Trovik Clement S, Monge Odd R, Hall Kirsten Sundby

机构信息

a Department of Oncology , Oslo University Hospital , Oslo , Norway.

b Department of Oncology , Haukeland University Hospital , Bergen , Norway.

出版信息

Acta Oncol. 2017 Mar;56(3):479-483. doi: 10.1080/0284186X.2016.1278305. Epub 2017 Jan 20.

DOI:10.1080/0284186X.2016.1278305
PMID:28105885
Abstract

BACKGROUND

Denosumab is a relatively new treatment option for patients with giant-cell tumor of bone (GCTB). The purpose of this study was to report the results for patients treated in Norway.

MATERIALS AND METHODS

Patients treated with denosumab for GCTB were identified from the clinical databases at the Norwegian sarcoma reference centers. Data were retrieved from the clinical databases and supplemented by retrospective review of patient records. Denosumab was given as a subcutaneous injection every 4 weeks with loading doses on day 8 and 15 in cycle 1.

RESULTS

Eighteen patients treated with denosumab for GCTB were identified. Denosumab was given for recurrent disease in seven cases and as first-line treatment in 11 patients, of which 6 received therapy as part of a neoadjuvant/adjuvant strategy and 5 for surgically unsalvageable primary tumor. Ten of 12 patients with unresectable disease are still on denosumab without progression with median treatment duration of 41 months (range 18-60). Two patients discontinued treatment due to osteonecrosis of the jaw and reduced compliance, respectively. In the adjuvant group, four patients experienced disease recurrence after stopping denosumab. In three of six patients, the extent of surgery was reduced due to neoadjuvant therapy. Seventeen of 18 patients underwent response evaluation with 18F-FDG PET/CT at median 4.7 weeks from starting denosumab. Median baseline SUV was 11.0 and median SUV at evaluation was 4.9 (p < 0.001).

CONCLUSIONS

In a nationwide GCTB patient cohort, denosumab was an effective agent and durable responses were observed. Our results do not support the use of adjuvant therapy in routine clinical practice. 18F-FDG PET/CT could be a valuable tool for early response evaluation.

摘要

背景

地诺单抗是骨巨细胞瘤(GCTB)患者一种相对较新的治疗选择。本研究的目的是报告挪威接受治疗患者的结果。

材料与方法

从挪威肉瘤参考中心的临床数据库中识别出接受地诺单抗治疗GCTB的患者。数据从临床数据库中检索,并通过回顾患者记录进行补充。地诺单抗每4周皮下注射一次,第1周期的第8天和第15天给予负荷剂量。

结果

识别出18例接受地诺单抗治疗GCTB的患者。地诺单抗用于7例复发性疾病,11例作为一线治疗,其中6例作为新辅助/辅助策略的一部分接受治疗,5例用于手术无法挽救的原发性肿瘤。12例不可切除疾病患者中有10例仍在接受地诺单抗治疗且无进展,中位治疗持续时间为41个月(范围18 - 60个月)。2例患者分别因颌骨坏死和依从性降低而停止治疗。在辅助治疗组中,4例患者在停止使用地诺单抗后出现疾病复发。6例患者中有3例因新辅助治疗手术范围缩小。18例患者中有17例在开始使用地诺单抗后中位4.7周接受了18F - FDG PET/CT反应评估。基线SUV中位数为11.0,评估时SUV中位数为4.9(p < 0.001)。

结论

在全国性的GCTB患者队列中,地诺单抗是一种有效的药物,并观察到持久反应。我们的结果不支持在常规临床实践中使用辅助治疗。18F - FDG PET/CT可能是早期反应评估的有价值工具。

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