Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone.
BACKGROUND
Malignant ascites (MA) is associated with poor prognosis and limited palliative therapeutic options. Therefore, quality of life (QoL) assessment is of particular importance to demonstrate new treatment value. Following the demonstration of the superiority of catumaxomab and paracentesis over paracentesis on puncture-free survival, this analysis aimed at comparing deterioration in QoL between both the treatment options.


METHODS
In a randomised, multicentre, phase II/III study of patients with MA due to epithelial cell adhesion molecule (EpCAM) positive cancer, the QoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) questionnaire at screening, 1, 3 and 7 months after treatment and in the case of re-puncture on the day of paracentesis. Time to first deterioration in QoL was defined as a decrease in the QoL score of at least five points and compared between the catumaxomab (n=160) and control (n=85) groups using the log-rank test and Cox proportional hazards models adjusted for baseline score, country and primary tumour type.


RESULTS
Deterioration in QoL scores appeared more rapidly in the control than in the catumaxomab group (median 19-26 days versus 47-49 days). The difference in time to deterioration in QoL between the groups was statistically significant for all scores (P<0.01). The hazard ratios ranged from 0.08 to 0.24 (P<0.01).


CONCLUSIONS
Treatment with catumaxomab delayed deterioration in QoL in patients with MA. Compared with paracentesis alone, catumaxomab enabled patients to benefit from better QoL for a prolonged survival period.
Gynaecology and Obstetrics Clinic, University of Duisburg-Essen, Essen, Germany.
P
P
Wimberger
Mapi Consultancy, Lyon, France. Electronic address: hgilet@mapigroup.com.
H
H
Gilet
Pricing, Reimbursement and Market Access, Fresenius Biotech GmbH, München.
A-K
AK
Gonschior
Department of Surgery, Cologne-Merheim Medical Center, Köln.
M M
MM
Heiss
1st Medical Clinic and Policlinic, Johannes-Gutenberg University, Mainz.
M
M
Moehler
Quality of Life Working Group of the North-Eastern German Society of Gynecological Oncology (NOGGO), Berlin.
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G
Oskay-Oezcelik
Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt.
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SE
Al-Batran
Department for Obstetrics and Gynecology, Technical University of Munich, München.
B
B
Schmalfeldt
Department of Hematology, Oncology and Transfusion Medicine, Charité University Hospital Berlin, Berlin.
A
A
Schmittel
Medical Affairs, Fresenius Biotech GmbH, München, Germany.
E
E
Schulze
Department of Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK.
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SL
Parsons
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018033:Antibodies, Bispecific / Q000627:therapeutic use*; D000951:Antigens, Neoplasm / Q000378:metabolism; D001201:Ascites / Q000378:metabolism / Q000473:pathology* / Q000628:therapy*; D015815:Cell Adhesion Molecules / Q000378:metabolism; D003131:Combined Modality Therapy; D000071858:Epithelial Cell Adhesion Molecule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000628:therapy*; D010051:Ovarian Neoplasms / Q000378:metabolism / Q000473:pathology / Q000628:therapy; D019152:Paracentesis / Q000379:methods*; D016016:Proportional Hazards Models; D011788:Quality of Life; D055815:Young Adult
D018033:Antibodies, Bispecific; D000951:Antigens, Neoplasm; D015815:Cell Adhesion Molecules; C499379:EPCAM protein, human; D000071858:Epithelial Cell Adhesion Molecule; C522419:catumaxomab