Ovarialkarzinom -- ist die intraperitoneale Therapie wirklich neuer Standard?
Standard
Ovarialkarzinom -- ist die intraperitoneale Therapie wirklich neuer Standard? / du Bois, A; Schmalfeldt, B; Meier, W; Sehouli, J; Pfisterer, J.
In: Zentralblatt für Gynäkologie, Vol. 128, No. 4, 08.2006, p. 202-6.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Ovarialkarzinom -- ist die intraperitoneale Therapie wirklich neuer Standard?
AU - du Bois, A
AU - Schmalfeldt, B
AU - Meier, W
AU - Sehouli, J
AU - Pfisterer, J
PY - 2006/8
Y1 - 2006/8
N2 - 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.
AB - 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.
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Controlled Clinical Trials as Topic
KW - Female
KW - Humans
KW - Injections, Intraperitoneal
KW - Multicenter Studies as Topic
KW - Ovarian Neoplasms
KW - Patient Compliance
KW - Survival Analysis
U2 - 10.1055/s-2006-933460
DO - 10.1055/s-2006-933460
M3 - SCORING: Zeitschriftenaufsatz
C2 - 16835814
VL - 128
SP - 202
EP - 206
IS - 4
ER -
