Department of Medical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Trial and Data Center, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.
ESMO Open. 2021 Aug;6(4):100229. doi: 10.1016/j.esmoop.2021.100229. Epub 2021 Aug 7.
Licensed systemic treatment options for platinum-sensitive recurrent ovarian cancer are platinum-based chemotherapy and maintenance treatment with bevacizumab and poly (ADP-ribose) polymerase inhibitors. For platinum-resistant disease, several non-platinum options are available. We aimed to assess the clinical benefit of these treatments according to the European Society of Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS).
A PubMed search was carried out including all studies evaluating systemic treatment of recurrent epithelial ovarian cancer, from 1990 onwards. Randomised trials with an adequate comparator and design showing a statistically significant benefit of the study arm were independently scored by two blinded observers using the ESMO-MCBS.
A total of 1127 papers were identified, out of which 61 reported results of randomised trials of sufficient quality. Nineteen trials showed statistically significant results and the studied treatments were graded according to ESMO-MCBS. Only three treatments showed substantial benefit (score of 4 on a scale of 1-5) according to the ESMO-MCBS: platinum-based chemotherapy with paclitaxel in the platinum-sensitive setting and the addition of bevacizumab to chemotherapy in the platinum-resistant setting. The WEE1 inhibitor adavosertib (not licensed) also scores a 4, based on a recent small phase II study. Assessment of quality-of-life data and toxicity using the ESMO-MCBS showed to be complex, which should be taken into account in using this score for clinical decision making.
Only a few licensed systemic therapies for recurrent ovarian cancer show substantial clinical benefit based on ESMO-MCBS scores. Trials demonstrating overall survival benefit are sparse.
铂类敏感复发性卵巢癌的许可系统治疗选择是铂类化疗和贝伐单抗及多聚(ADP-核糖)聚合酶抑制剂维持治疗。对于铂类耐药疾病,有几种非铂类选择。我们旨在根据欧洲肿瘤内科学会(ESMO)临床获益量表(MCBS)评估这些治疗的临床获益。
进行了一项 PubMed 检索,其中包括评估复发性上皮性卵巢癌系统治疗的所有研究,时间从 1990 年开始。对具有足够对照和设计的随机试验,且研究组具有统计学显著获益的独立进行了两名盲法观察者的评分,使用 ESMO-MCBS。
共确定了 1127 篇论文,其中 61 篇报道了足够质量的随机试验结果。19 项试验显示出统计学显著结果,并且根据 ESMO-MCBS 对研究治疗进行了分级。只有三种治疗方法(根据 ESMO-MCBS 的评分范围为 1-5,评分 4)根据 ESMO-MCBS 显示出实质性获益:铂类化疗联合紫杉醇在铂类敏感环境中,以及在铂类耐药环境中添加贝伐单抗联合化疗。WEE1 抑制剂adavosertib(未获许可)也基于最近的一项小型 II 期研究,评分 4。使用 ESMO-MCBS 评估生活质量数据和毒性显示较为复杂,在使用该评分进行临床决策时应考虑到这一点。
只有少数许可的复发性卵巢癌系统治疗方法根据 ESMO-MCBS 评分显示出实质性的临床获益。显示总生存获益的试验很少。