未经证实:在乳腺癌和前列腺癌患者中,骨转移(BM)是发病的主要原因,通常会引起使人衰弱的疼痛,功能受损和随后的生活质量(QoL)恶化。BM的管理仍然具有挑战性。QoL的维持或改善是治疗的主要目标。抗再吸收治疗,例如denosumab和双膦酸盐,可以帮助减少骨骼并发症的频率,控制骨痛并可能改善QoL。开始抗再吸收治疗的最佳时间点仍有争议。在BM患者中,骨痛可作为QoL的替代指标。然而,在抗吸收治疗的BM患者中,与健康相关的QoL的数据有限。PROBone注册研究在德国使用患者报告的结果(PRO)评估了由BM引起的乳腺癌和前列腺癌患者的投诉和局限性。
UNASSIGNED:在2014年至2019年之间,有500例组织学确认为晚期乳腺癌或前列腺癌的患者,首次抗再吸收治疗开始时被诊断为BM的患者被前瞻性纳入德国65个内科肿瘤学门诊中心.使用经过验证的疼痛评分癌症治疗功能评估骨痛患者的生活质量测量(FACT-BP),从基线开始每月评估QoL的变化,直至最长12个月,并补充有关一般疼痛和影响的问题。用于治疗疾病的时间对患者的日常活动。通过相对和绝对频率进行描述性统计分析。
未经批准:总共,486名患者符合最终分析条件,其中310例被诊断为乳腺癌,176例被诊断为前列腺癌。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%的乳腺癌患者和59.7%的前列腺患者在诊断出BM后3个月内开始抗再吸收治疗。研究纳入时,超过75%的患者患有骨痛。在观察期间,总共有52%的乳腺癌患者和47.9%的前列腺癌患者报告服用止痛药。在乳腺癌和前列腺癌患者中,观察到BTA开始后的初始疼痛减轻:一般疼痛和骨痛水平以及中位数FACT-BP评分在最初的几个月中显示出持续的改善,此后保持稳定在恒定水平。亚组分析显示,在整个观察期间,基线无疼痛患者的FACT-BP评分明显优于基线疼痛患者。看看时间-压力(M)-分数,年轻乳腺癌患者(<65岁)表现出最高的负担,尤其是在治疗的头几个月.
UASSIGNED:我们的结果表明总体上对当前指南建议的遵守情况良好,大多数乳腺癌和前列腺癌患者在诊断出BM后的前3个月内开始抗再吸收治疗。这一点变得更加重要,因为我们的数据支持ESMO指南以及德国基于证据的S3指南对乳腺癌和前列腺癌的诊断和治疗的当前建议,以便在BM诊断后立即启动骨靶向药物(BTA)。将疼痛水平保持在最低水平,尽量减少转移性骨痛的衰弱效应,保持良好的生活质量。BM诊断后早期使用BTA治疗骨痛可能会改善患者护理。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.