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

TY - JOUR

T1 - 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

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

N1 - Copyright © 2011 Elsevier Inc. All rights reserved.

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 - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antibodies, Bispecific

KW - Disease-Free Survival

KW - Dose-Response Relationship, Drug

KW - Drug Resistance, Neoplasm

KW - Female

KW - Humans

KW - Infusions, Parenteral

KW - Middle Aged

KW - Neoplasms, Glandular and Epithelial

KW - Organoplatinum Compounds

KW - Ovarian Neoplasms

U2 - 10.1016/j.ygyno.2011.06.004

DO - 10.1016/j.ygyno.2011.06.004

M3 - SCORING: Journal article

C2 - 21733566

VL - 123

SP - 27

EP - 32

JO - GYNECOL ONCOL

JF - GYNECOL ONCOL

SN - 0090-8258

IS - 1

ER -