TY - JOUR
T1 - Intraperitoneal treatment with the trifunctional bispecific antibody Catumaxomab in patients with platinum-resistant epithelial ovarian cancer
T2 - A phase IIa study of the AGO Study Group
AU - Baumann, K.
AU - Pfisterer, J.
AU - Wimberger, P.
AU - Burchardi, N.
AU - Kurzeder, C.
AU - Du Bois, A.
AU - Loibl, S.
AU - Sehouli, J.
AU - Huober, J.
AU - Schmalfeldt, B.
AU - Vergote, I.
AU - Lück, H. J.
AU - Wagner, U.
PY - 2011/10
Y1 - 2011/10
N2 - Objective: The aim of this study was to select the best catumaxomab regimen for further investigation in ovarian cancer based on confirmed tumour response. Methods: Randomised 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. Results: Forty-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. Conclusion: Catumaxomab 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.
AB - Objective: The aim of this study was to select the best catumaxomab regimen for further investigation in ovarian cancer based on confirmed tumour response. Methods: Randomised 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. Results: Forty-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. Conclusion: Catumaxomab 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.
KW - Catumaxomab
KW - Platinum-resistant
KW - Recurrent ovarian cancer
UR - http://www.scopus.com/inward/record.url?scp=80052593787&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2011.06.004
DO - 10.1016/j.ygyno.2011.06.004
M3 - Article
C2 - 21733566
AN - SCOPUS:80052593787
SN - 0090-8258
VL - 123
SP - 27
EP - 32
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 1
ER -
