[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.
du Bois
A
A
Klinik für Gynäkologie und gynäkologische Onkologie, HSK Dr. Horst Schmidt Klinik, Wiesbaden. dubois.hsk-wiesbaden@uumail.de
Schmalfeldt
B
B
Meier
W
W
Sehouli
J
J
Pfisterer
J
J
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018849:Controlled Clinical Trials as Topic; D005260:Female; D006801:Humans; D007274:Injections, Intraperitoneal; D015337:Multicenter Studies as Topic; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D010349:Patient Compliance; D016019:Survival Analysis