Möbus Volker, Hell Susanne, Schmidt Marcus
Klinik für Gynäkologie und Geburtshilfe, Klinikum Frankfurt-Höchst, Frankfurt, Germany.
Roche Pharma AG, Grenzach-Wyhlen, Germany.
Geburtshilfe Frauenheilkd. 2017 Oct;77(10):1079-1087. doi: 10.1055/s-0043-119542. Epub 2017 Oct 26.
Oncologic therapy is currently undergoing significant changes. A number of innovative targeted medications currently in clinical development have raised high expectations. With that in mind, discussions about terms such as "clinical benefit" and "clinical relevance" are highly topical. This also applies to further developments in the field of adjuvant systemic therapies for early-stage breast cancer. As the treatment aim is curative, assessment of the clinical benefit of adjuvant therapies must be largely based on efficacy outcomes. The focus must be on improving disease-free survival rates and lowering the risk of recurrence. Because of the current low mortality rates, statements about overall survival rates are only possible after very long observation periods. Consequently, new drugs in adjuvant therapies should be considered as offering a clinical benefit, if they reduce the risk of recurrence below current low levels of risk. The evidence for established adjuvant therapy standards in early-stage breast cancer can be used as objective criteria for comparison. This review article considers the requirements for clinical benefit of new adjuvant therapies for early breast cancer, based on examples from adjuvant endocrine therapy, adjuvant polychemotherapy and adjuvant anti-HER2 therapy.
肿瘤治疗目前正在经历重大变革。一些正在进行临床开发的创新靶向药物引发了人们的高度期待。考虑到这一点，关于“临床获益”和“临床相关性”等术语的讨论非常热门。这也适用于早期乳腺癌辅助全身治疗领域的进一步发展。由于治疗目标是治愈性的，辅助治疗临床获益的评估必须主要基于疗效结果。重点必须放在提高无病生存率和降低复发风险上。由于目前死亡率较低，只有在很长的观察期后才能得出关于总生存率的结论。因此，如果辅助治疗中的新药能将复发风险降低到目前的低风险水平以下，就应被视为具有临床获益。早期乳腺癌既定辅助治疗标准的证据可作为客观的比较标准。本文基于辅助内分泌治疗、辅助多药化疗和辅助抗HER2治疗的实例，探讨了早期乳腺癌新辅助治疗临床获益的要求。
