Ovarialkarzinom - ist die intraperitoneale Therapie wirklich neuer Standard?

Zusammenfassung

Kürzlich wurde durch die Publikation der GOG-172-Studie die intraperitoneale (i. p.) Chemotherapie bei Patientinnen mit Ovarialkarzinom als potenzieller neuer Standard dargestellt. Die AGO Kommission Ovar, die AGO-OVAR und die NOGGO widersprechen dieser Darstellung. So wurden in der GOG-172-Studie mehrere Variablen vermischt, und die i. p.-Therapie nicht mit dem aktuellen Standard Paclitaxel plus Carboplatin verglichen. Die Analyse erfolgte nicht in einer Intention-to-treat-(ITT)-Population, und signifikante Ergebnisse könnten durch geringste Verschiebungen ihre Signifikanz verlieren. Ferner lieferte die GOG-172-Studie keine Details zur Second-line-Therapie, die Einfluss auf das Gesamtüberleben haben könnte. Die ausgeprägte Toxizität und infolgedessen geringe Zyklenzahl der i. p.-Therapie könnte den signifikanten Effekt infrage stellen. Die geringe mediane Überlebenszeit der GOG-172-Studie im Kontrollarm (49,7 Monate) weicht von vergleichbaren Kollektiven dreier AGO-OVAR Studien und der GOG 158 (56,5-59,5 Monate) ab. Wäre das Ergebnis der GOG 172 ähnlich gewesen, gäbe es im Vergleich zur i. p.-Therapie keine Signifikanz. Um den aktuellen Standard zu ändern, müsste die Analyse in einer ITT-Population erfolgen, Details zur Second-line-Therapie veröffentlicht, ein Bias bezüglich der Second-line-Therapie ausgeschlossen und ein weniger toxisches Regime entwickelt werden.

Abstract

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.

Ovarialkarzinom - intravenöse Chemotherapie - intraperitoneale Chemotherapie

ovarian cancer - intravenous chemotherapy - intraperitoneal chemotherapy

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