Universität zu Köln

Kurbacher, Christian Martin, Horn, Olympia, Kurbacher, Jutta Anna, Herz, Susanne, Kurbacher, Ann Tabea, Hildenbrand, Ralf and Bollmann, Reinhardt (2015). Outpatient Intraperitoneal Catumaxomab Therapy for Malignant Ascites Related to Advanced Gynecologic Neoplasms. Oncologist, 20 (11). S. 1333 - 1342. DURHAM: ALPHAMED PRESS. ISSN 1549-490X

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Abstract

Background. Catumaxomab (CATU) is a trifunctional antibody approved for intraperitoneal (i.p.) treatment of malignant ascites (MA) related to carcinomas expressing the epithelial cell-adhesion molecule (EpCAM). CATU is mostly given to hospitalized patients, although outpatient treatment seems appropriate in selected individuals. This observational trial sought to obtain more detailed information regarding the feasibility of CATU in outpatients with MA related to various gynecologic tumors, including epithelial ovarian (EOC) and metastatic breast cancer (MBC). Materials and Methods. A total of 30 patients were included, 17 with EOC, 7 with MBC, and 6 with other malignancies. The patients had failed a median of 5(range 1-12) previous systemic treatments. CATU was administered via an indwelling i.p. catheter at four increasing doses(i.e., 10,20, 50, and 150 mu g) given at 4-day intervals over 2 weeks. Toxicities were scored according to the Common Terminology Criteria for Adverse Events, version 4.03. Puncture-free survival (PuFS) was calculated from the start of CATU until the next puncture for MA, death, or loss to follow-up. Overall survival (OS) was calculated from the start of CATU to death from any reason or loss to follow-up. We also investigated various clinical parameters to predict PuFS and OS. These included age, tumor type, performance status, intensity of pretreatment, presence of extraperitoneal metastases, relative lymphocyte count at baseline, patient adherence to therapy, and the patients' ability to undergo systemic treatment after CATU. Results. CATU was exclusively given on an outpatient basis, and 19 patients (63.3%) received all four planned i.p. instillations. Toxicity was the reason for discontinuation in only 2 patients. Toxicity was generally manageable, with abdominal pain, nausea/vomiting, fatigue, and fever the predominant adverse effects. Secondary hospitalization was necessary for 7 patients (23.3%), with a general deteriorated condition in 5 and fever/infection or abdominal pain in 1 patient each. Subsequent systemic treatment was possible in 11 patients(36.7%). Only 5 patients(16.7%) required a second puncture after i.p. CATU. The median PuFS was 56 days, and the median OS was 79.5 days. Positive predictors of both PuFS and OS were performance status, absence of extraperitoneal tumor, the capability to receive all four CATU infusions, and the ability to undergo subsequent systemic treatment. Conclusion. Outpatient i.p. CATU therapy for MA related to various gynecologic carcinomas is safe and effective in producing good ascites control in most individuals, allowing for subsequent systemic therapy in a substantial proportion of patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kurbacher, Christian Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Horn, Olympia UNSPECIFIED UNSPECIFIED UNSPECIFIED Kurbacher, Jutta Anna UNSPECIFIED UNSPECIFIED UNSPECIFIED Herz, Susanne UNSPECIFIED UNSPECIFIED UNSPECIFIED Kurbacher, Ann Tabea UNSPECIFIED UNSPECIFIED UNSPECIFIED Hildenbrand, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Bollmann, Reinhardt UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-388987
DOI:	10.1634/theoncologist.2015-0076
Journal or Publication Title:	Oncologist
Volume:	20
Number:	11
Page Range:	S. 1333 - 1342
Date:	2015
Publisher:	ALPHAMED PRESS
Place of Publication:	DURHAM
ISSN:	1549-490X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TRIFUNCTIONAL ANTIBODY CATUMAXOMAB; PHASE II/III; OVARIAN-CANCER; TUMOR-CELLS; IMMUNOTHERAPY; PARACENTESIS; PATIENT Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/38898