A matched pair analysis of intra- and postoperative catumaxomab in patients with ovarian cancer from a multicenter, single-arm phase II trial versus a consecutive single-center collective of ovarian cancer patients without immunotherapy
| Autor: | Miriam Tschirschmann, Radoslav Chekerov, Jalid Sehouli, Christina Fotopoulou, Toralf Reimer, Lukas Angleitner-Boubenizek, Elena Ioana Braicu, Horst Lindhofer, Klaus Pietzner, Alexander Reinthaller, Daniel Reimer |
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| Rok vydání: | 2012 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 30:5080-5080 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2012.30.15_suppl.5080 |
| Popis: | 5080 Background: Advanced ovarian cancer is still connected to high mortality rates due to intraperitoneal tumor cells that survive radical cytoreductive surgery as well as adjuvant chemotherapy. These persistent tumor cells need to be targeted in order to improve survival. Catumaxomab has demonstrated the ability to kill EpCAM-positive intraperitoneal tumor cells of ovarian cancer patients in studies aiming to controll malignant ascites in the recurrent setting. This analysis was conducted to investigate the efficacy of intraperitoneal catumaxomab at the timepoint of primary cytoreductive surgery and postoperative period, prior to standard adjuvant chemotherapy. Methods: Ovarian cancer patients undergoing radical surgery received one intraoperative (10 μg) followed by four subsequent intraperitoneal (i.p.) dosages (10, 20, 50 and 150 μg) of catumaxomab on days 7, 10, 13, and 16, respectively. Because of the single arm design of the study, the patients treated with catumaxomab were compared in a matched pair analysis to consecutive patients with primary ovarian cancer who received standard treatment without catumaxomab in a large center, in order to compare survival. The two main prognostic factors of stage and level of tumorreduction were chosen as matching criteria. Results: Of 58 patients screened, 41 were treated with catumaxomab and available for survival evaluation. Median age was 57 years in the catumaxomab group and 59 years in the matched-pair control group. The most comon histology was the serous subtype with 70.7 % in the catumaxomab and 80.5 % of the patients in the control group. The median for overall survival was reached for the historical consecutive matched-pair control collective, but is not yet reached for the catumaxomab group. However, 3-year survival data were available for both groups and showed survival of 85.4% (35) in the catumaxomab group and 63.4% (26) in the matched-pair control group (p-value: 0.041; HR 2.073) Conclusions: There seems to be a trend to beneficial 3-year survival in the catumaxomab group, suggesting that a phase III trial is warranted. |
| Databáze: | OpenAIRE |
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