Fick E-M, Anzeneder T, Katalinic A, Waldmann A
Institut für Sozialmedizin und Epidemiologie, UKSH Campus Lübeck, Lübeck.
Stiftung PATH Patients' Tumor Bank of Hope, München.
Geburtshilfe Frauenheilkd. 2013 May;73(5):412-421. doi: 10.1055/s-0032-1328502.
Bisphosphonates are well known above all for their use in the treatment of osteoporosis. They also play an important role as accompanying therapy for advanced tumour diseases with extensive spread into the skeletal system. Their adjuvant use in the treatment of breast cancer without bony metastases is currently a subject of controversial discussion. The objective of the present evaluation is to describe the use of bisphosphonates in the therapy for breast cancer. We will show how frequently bisphosphonates are used, which bisphosphonates are preferred and what specific features patients under bisphosphonate therapy exhibit. The pseudonymous data set from the biobank of the German PATH foundation was used for the evaluation. From the total collective, 2492 patients were selected after consideration of the inclusion and exclusion criteria. The selected patient collective was divided into two groups (with and without bisphosphonate therapy) and the two groups compared with one another with the help of descriptive statistics. 17.5 % of the 2492 patients had prescriptions for a bisphosphonate as part of their therapy. The most frequently administered bisphosphonate was zoledronate. Pathological (induced by tumour therapy) osteoporosis was the most frequently stated indication among the bisphosphonate patients, followed by consumption starting prior to the breast cancer therapy and treatment of bony metastases. Patients under bisphosphonate and antihormonal therapy frequently received an aromatase inhibitor as the active principle in the antihormonal therapy whereas patients under antihormonal therapy but without bisphosphonates more frequently received tamoxifen as active principle. Ten of the 2492 patients reported receiving bisphosphonate therapy as prophylaxis for bony metastases without a documented and approved indication. Use of bisphosphonates in the course of the GAIN, ICE, SUCCESS or, respectively, NATAN trials was reported by 29 of the 2492 patients. In the PATH collective, bisphosphonates were employed above all for the treatment of (tumour therapy-induced) osteoporosis and bony metastases. Off-label use and participation in clinical trials played only a minor role in this patient collective. Against the background of the uncertain data status for the adjuvant use of bisphosphonates, the development (and use) of standardised, validated questionnaires to record the indications for and frequency of use of bisphosphonate therapy is recommended.
双膦酸盐最为人所知的用途是治疗骨质疏松症。它们在伴有广泛骨骼系统转移的晚期肿瘤疾病的辅助治疗中也发挥着重要作用。目前，双膦酸盐在无骨转移乳腺癌治疗中的辅助应用是一个有争议的讨论话题。本次评估的目的是描述双膦酸盐在乳腺癌治疗中的应用情况。我们将展示双膦酸盐的使用频率、哪种双膦酸盐更受青睐以及接受双膦酸盐治疗的患者有哪些具体特征。评估使用了德国PATH基金会生物样本库的匿名数据集。在考虑纳入和排除标准后，从总体人群中选取了2492名患者。将所选患者群体分为两组（接受和未接受双膦酸盐治疗），并借助描述性统计对两组进行比较。2492名患者中有17.5%的患者在治疗过程中开具了双膦酸盐处方。使用最频繁的双膦酸盐是唑来膦酸。病理性（由肿瘤治疗引起）骨质疏松是双膦酸盐治疗患者中最常提及的适应症，其次是在乳腺癌治疗前开始使用以及治疗骨转移。接受双膦酸盐和抗激素治疗的患者在抗激素治疗中经常使用芳香化酶抑制剂作为活性成分，而接受抗激素治疗但未使用双膦酸盐的患者更常使用他莫昔芬作为活性成分。2492名患者中有10名报告在没有记录在案且经批准的适应症的情况下接受双膦酸盐治疗以预防骨转移。2492名患者中有29名报告在GAIN、ICE、SUCCESS或NATAN试验过程中使用了双膦酸盐。在PATH患者群体中，双膦酸盐主要用于治疗（肿瘤治疗引起的）骨质疏松和骨转移。在该患者群体中，超说明书用药和参与临床试验的情况仅占较小比例。鉴于双膦酸盐辅助应用的数据状况不确定，建议开发（并使用）标准化、经过验证的问卷来记录双膦酸盐治疗的适应症和使用频率。
