Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.
MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Gynecol Oncol. 2019 May;153(2):436-444. doi: 10.1016/j.ygyno.2019.02.008. Epub 2019 Feb 12.
Ovarian cancer has a high mortality to case ratio. To improve the initial response to therapy, trials of biologic agents in combination with primary chemotherapy and as maintenance after completing chemotherapy are being conducted. Multiple trials are ongoing and this strategy has great promise. However, the changing landscape of primary treatment will make designing future trials in ovarian cancer difficult as there may not be a consensus on the optimal primary therapy.
We reviewed clinicaltrials.gov for recent and ongoing phase III clinical trials that are likely to impact primary therapy in ovarian cancer. We summarized the objectives and the available data from these trials.
A total of 12 potentially practice-changing, randomized phase III trials in front line ovarian cancer were identified in which a biologic therapy was added to primary chemotherapy and/or was used in the maintenance setting. These trials included PARP inhibitors (PARPi), anti-angiogenic agents, immuno-oncology agents, and combinations of these agents. Of the 12 trials, 10 are ongoing, one was terminated for futility, and one has been recently reported. All of these trials emphasize the use of maintenance targeted therapy. In addition, 7 randomized phase III trials utilizing hyperthermic intraperitoneal chemotherapy (HIPEC) were identified in the setting of upfront ovarian cancer treatment.
There are multiple ongoing trials in primary ovarian cancer. These trials investigate PARPi, anti-angiogenic agents, immuno-oncology agents, combinations of these agents, and HIPEC. Many of these trials will mature within the next several years and are likely to change the primary treatment of women with ovarian cancer.
卵巢癌的死亡率与发病率之比很高。为了提高初始治疗反应，正在进行将生物制剂与初始化疗联合使用，并在完成化疗后作为维持治疗的试验。多项试验正在进行中，这一策略具有很大的前景。然而，由于可能没有关于最佳初始治疗的共识，原发性治疗的不断变化可能会使卵巢癌的未来试验设计变得困难。
我们在 clinicaltrials.gov 上检索了最近和正在进行的可能影响卵巢癌初始治疗的 III 期临床试验。我们总结了这些试验的目标和现有数据。
共确定了 12 项可能改变实践的、一线卵巢癌的 III 期随机试验，其中生物疗法被添加到初始化疗中，和/或用于维持治疗。这些试验包括 PARP 抑制剂（PARPi）、抗血管生成药物、免疫肿瘤学药物以及这些药物的组合。在这 12 项试验中，有 10 项正在进行，1 项因无效而终止，1 项最近已报告。所有这些试验都强调了维持靶向治疗的应用。此外，还确定了 7 项在初始卵巢癌治疗中使用腹腔内热灌注化疗（HIPEC）的 III 期随机试验。
目前有多项关于原发性卵巢癌的临床试验正在进行。这些试验研究了 PARPi、抗血管生成药物、免疫肿瘤学药物、这些药物的组合以及 HIPEC。其中许多试验将在未来几年内成熟，并可能改变卵巢癌女性的初始治疗。
