【卵巢癌——腹膜疗法能被视为新标准吗?】

A du Bois, B Schmalfeldt, W Meier, J Sehouli, J Pfisterer
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引用次数: 0

摘要

最近,GOG 172试验的发表使得卵巢癌患者的腹腔化疗被视为潜在的新标准。AGO- Ovar委员会、AGO- Ovar和NOGGO不同意这一观点。在GOG 172研究中,几个变量是混合的,i.p.t治疗没有与目前标准的紫杉醇加卡铂进行比较。该分析不是基于意向治疗(ITT)人群,而即使是最微小的显著结果变化也可能导致其显著性被消除。此外,GOG 172试验没有提供任何可能影响总生存期的二线治疗的细节。高毒性和低周期的i - p治疗可能会使显著效果受到质疑。对照组中GOG 172试验的低中位生存时间(49.7个月)与三个AGO-OVAR试验和GOG 158研究(56.5-59.5个月)的可比数据不同。如果GOG 172试验的结果是相似的,那么与i.p.t治疗相比就没有任何意义了。为了改变目前的标准,有必要以itt人群为基础进行分析,提供二线治疗的细节,排除二线治疗的偏见,并制定毒性较小的方案。
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[Ovarian cancer -- can peritoneal therapy be regarded as new standard?].

Recently, the publication of the GOG 172 trial led to intraperitoneal (i. p.) chemotherapy in patients with ovarian cancer being regarded as potential new standard. The AGO Kommission Ovar, AGO-OVAR and NOGGO disagree with this view. In the GOG 172 study, several variables were mixed, and i. p.-therapy was not compared to the current standard paclitaxel plus carboplatin. The analysis was not based on an intention-to-treat (ITT) population, while even the slightest changes of significant results could lead to the elimination of their significance. Furthermore, the GOG 172 trial did not provide any details on second-line treatment which could have an impact on overall survival. High toxicity and the low number of cycles in i. p.-therapy might call the significant effect into question. The low median time of survival of the GOG 172 trial in the control arm (49.7 months) diverges from comparable collectives of three AGO-OVAR trials and the GOG 158 study (56.5-59.5 months). If the result of the GOG 172 trial had been similar, there would not have been any significance in comparison to i. p.-therapy. In order to change the current standard, it would be necessary to base the analysis on an ITT-population, provide details about second-line therapy, rule out bias regarding second-line therapy and to develop less toxic regimens.

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