Intraperitoneal treatment with the trifunctional bispecific antibody Catumaxomab in patients with platinum-resistant epithelial ovarian cancer: a phase IIa study of the AGO Study Group |
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| Authors: | Baumann K Pfisterer J Wimberger P Burchardi N Kurzeder C du Bois A Loibl S Sehouli J Huober J Schmalfeldt B Vergote I Lück H J Wagner U |
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| Affiliation: | aUniversity of Marburg, Dept. of Gynaecology, Germany;bDept. of Gynaecology and Obstetrics, University of Kiel, Germany;cUniversity of Duisburg-Essen, Department of Gynaecology and Obstetrics, Essen, Germany;dCo-ordinating Centre for Clinical Trials Marburg, University of Marburg, Germany;eDept. of Gynaecology and Obstetrics, University of Ulm, Germany;fDept. of Gynaecology and Gynaecological Oncology, HSK Wiesbaden and Kliniken Essen Mitte, Germany;gDept. of Gynaecology and Obstetrics, University of Frankfurt/Main, Germany;hDepartment of Gynaecology and Obstetrics, Charité, Berlin, Germany;iUniversity Hospital, Department of Gynaecology and Obstetrics, Tübingen, Germany;jDepartment of Gynaecology and Obstetrics, Technical University of Munich, Germany;kGynaecologic Oncology, University of Leuven, Belgium;lDept. of Gynaecology and Obstetrics, Medical School Hannover, Germany |
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| Abstract: | ObjectiveThe aim of this study was to select the best catumaxomab regimen for further investigation in ovarian cancer based on confirmed tumour response.MethodsRandomised open-label phase IIa study in women with platinum-resistant or -refractory epithelial ovarian cancer. Catumaxomab (6-hour intraperitoneal infusion on days 0, 3, 7 and 10) was administered at a low (10, 10, 10 and 10 μg) or high dose (10, 20, 50 and 100 μg). Responders were patients with either a complete (CR) or partial (PR) response.ResultsForty-five patients were randomised to receive either low dose (23) or high dose (22). There were no responders in the low-dose versus one patient (5%) in the high-dose group with a PR. In the low-dose group, two patients (9%) had stable disease compared with five patients (23%) in the high-dose group. Catumaxomab was well tolerated and there was no difference between the dose groups in the incidence of treatment-induced adverse events, the most common of which were gastrointestinal and injection-site reactions.ConclusionCatumaxomab had modest activity in platinum-resistant ovarian cancer. The high-dose regimen was associated with a slightly better therapeutic index than the low dose regimen. |
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| Keywords: | Recurrent ovarian cancer Catumaxomab Platinum-resistant |
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