Fragestellung:
Patients suffering from malignant ascites (MA) experience burdensome symptoms and
an impaired quality of life (QoL) So far, therapeutic options are limited. The trifunctional
antibody catumaxomab is approved for the treatment of MA. Its superiority over paracentesis
including a positive trend in overall survival has been demonstrated in a pivotal
study. The objective of this analysis was to compare ascites symptoms and QoL of patients
treated with catumaxomab or paracentesis.
Methode:
QoL and ascites symptoms were assessed for patients with MA randomized to catumaxomab
(N=170) and paracentesis (N=88) using the EORTC QLQ-C30 and a symptom questionnaire
at different visits (screening, months 1, 3, and 7, and re-puncture). QoL was assessed
using time to first deterioration in QLQ-C30 scores defined as decrease in scores
of at least 5 points. QoL was compared between treatment groups using survival methods
with log-rank test and Cox models The rate of symptom-free patients was compared between
treatment groups using Fisher's exact test.
Ergebnisse:
Deterioration in QoL scores appeared more rapidly in control than in the catumaxomab
group (median: 16–28 days vs. 45–49 days). The difference in time to first deterioration
in QoL between groups was statistically significant for all 15 QLQ-C30 scores (p<0.05)
and results were confirmed using Cox models (p<0.05 for all scores) with hazard ratios
(0.08 for nausea andvomiting up to 0.42 for constipation, risk reduction of 92 to
58%). Accordingly, at the visits 8 days, 1 month and 3 months after treatment more
patients in the catumaxomab group were symptom-free compared to control (34–52% vs.
17–36%, 22–33% vs. 5–6% and 6–10% vs. 0%).
Schlussfolgerung:
Catumaxomab maintains patients at a health status with a better QoL for a longer period
of life and a prolonged reduction of ascites symptoms compared to paracentesis.
