Background

In breast cancer and prostate cancer patients, bone metastases (BM) present the main cause of morbidity and often cause debilitating pain, impaired functioning and subsequent deterioration of quality of life (QoL). The management of BM is still challenging. Maintenance or improvement in QoL is the main goal of treatment. Antiresorptive treatment, such as denosumab and bisphosphonates, can help to reduce the frequency of skeletal complications, to control bone pain and potentially to improve QoL. The optimal time point for initiation of antiresorptive therapy is still discussed controversially. In patients with BM, bone pain can be used as a surrogate measure of QoL. However, limited data exist on health-related QoL in patients with BM under antiresorptive treatment. The PROBone registry study evaluated complaints and limitations caused by BM of breast and prostate cancer patients using patient-reported outcomes (PROs) in real-world in Germany.

Methods

Between 2014 and 2019, 500 patients with histological confirmation of advanced breast or prostate cancer, diagnosed with BM at start of their first antiresorptive therapy were prospectively enrolled in 65 outpatient-centers specialized in medical oncology across Germany. Changes of QoL were assessed monthly from baseline until a maximum of 12 months using the validated pain score Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain (FACT-BP) supplemented by questions on general pain and on the impact of time spent for treatment of illness on patients’ daily activities. Statistical analysis was performed descriptively by relative and absolute frequencies.

Results

In total, 486 patients were eligible for final analysis, of these 310 were diagnosed with breast cancer and 176 with prostate cancer. Median age was 67 years for breast cancer and 76 years for prostate cancer patients. 79.7% of breast cancer and 59.7% of prostate patients started antiresorptive treatment within 3 months after diagnosis of BM. More than 75% of patients suffered from bone pain at study inclusion. In total 52% of breast cancer patients and 47.9% of prostate cancer patients reported to take pain medication during the observation period. In breast and prostate cancer patients an initial pain reduction after start of BTA was observed: General pain and bone pain levels as well as the median FACT-BP score showed a constant improvement over the first months and maintained stable at a constant level afterwards. Subgroup analysis showed that patients without pain at baseline reported distinctly better FACT-BP scores throughout the whole observation period than patients with pain at baseline. Looking at time-stress (M)-scores, younger breast cancer patients (<65 years) showed highest burden especially during the first months of treatment.

Conclusions

Our results indicate overall good adherence to current guideline recommendation, with most breast and prostate cancer patients starting antiresorptive therapy within the first 3 months after diagnosis of BM. This point gains even more importance as our data support current recommendations by ESMO guidelines as well as by German evidence-based S3-guidelines for diagnosis and treatment of breast and prostate cancer to initiate bone-targeted agents (BTA) as soon as BM are diagnosed, to keep pain levels at the lowest level possible, to minimize the debilitating effects of metastatic bone pain and maintain a good QoL. Bone pain management by an early use of BTA following BM diagnosis might improve patient care

中文翻译：

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接受抗骨转移治疗的乳腺癌或前列腺癌患者的真实患者报告结果：PROBone 注册研究的最终结果

 背景

在乳腺癌和前列腺癌患者中，骨转移 (BM) 是发病的主要原因，通常会导致衰弱性疼痛、功能受损以及随后的生活质量 (QoL) 恶化。 BM的管理仍然具有挑战性。维持或改善生活质量是治疗的主要目标。抗骨吸收治疗，例如地诺塞麦和双磷酸盐，可以帮助减少骨骼并发症的发生频率，控制骨痛，并有可能改善生活质量。开始抗骨吸收治疗的最佳时间点仍有争议。对于 BM 患者，骨痛可以作为生活质量的替代指标。然而，关于接受抗骨吸收治疗的骨转移患者的健康相关生活质量的数据有限。 PROBone 注册研究使用德国现实世界中的患者报告结果 (PRO) 评估了乳腺癌和前列腺癌患者的 BM 引起的投诉和限制。

 方法

2014 年至 2019 年间，德国 65 个专门从事肿瘤内科的门诊中心前瞻性招募了 500 名组织学证实为晚期乳腺癌或前列腺癌、在首次抗骨吸收治疗开始时诊断为 BM 的患者。使用经过验证的疼痛评分对骨痛患者的癌症治疗生活质量测量功能评估 (FACT-BP) 进行每月评估，从基线开始直至最长 12 个月，并补充有关一般疼痛和时间影响的问题用于治疗疾病的患者日常活动的费用。通过相对和绝对频率进行描述性统计分析。

 结果

总共有 486 名患者符合最终分析的条件，其中 310 名患者被诊断为乳腺癌，176 名患者被诊断为前列腺癌。乳腺癌患者的中位年龄为 67 岁，前列腺癌患者的中位年龄为 76 岁。 79.7% 的乳腺癌和 59.7% 的前列腺癌患者在诊断 BM 后 3 个月内开始抗骨吸收治疗。超过 75% 的患者在纳入研究时患有骨痛。总共有 52% 的乳腺癌患者和 47.9% 的前列腺癌患者报告在观察期间服用了止痛药。在乳腺癌和前列腺癌患者中，观察到 BTA 开始后最初的疼痛减轻：一般疼痛和骨痛水平以及中位 FACT-BP 评分在最初几个月内持续改善，并在之后保持稳定在恒定水平。亚组分析显示，在整个观察期间，基线时没有疼痛的患者报告的 FACT-BP 评分明显优于基线时疼痛的患者。从时间压力 (M) 评分来看，年轻乳腺癌患者（<65 岁）的负担最高，尤其是在治疗的前几个月。

 结论

我们的结果表明总体上很好地遵守了当前的指南建议，大多数乳腺癌和前列腺癌患者在诊断 BM 后的前 3 个月内开始抗吸收治疗。这一点变得更加重要，因为我们的数据支持 ESMO 指南以及德国循证 S3 指南关于乳腺癌和前列腺癌诊断和治疗的当前建议，一旦诊断出 BM，就启动骨靶向药物 (BTA) ，将疼痛水平保持在尽可能低的水平，最大限度地减少转移性骨痛的衰弱影响并保持良好的生活质量。 BM 诊断后早期使用 BTA 来管理骨痛可能会改善患者护理