Quality of life in patients with malignant ascites and after treatment with catumaxomab: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone

• Main Authors: Schmalfeldt, B, Seck, K, Gonschior, AK, Gilet, H, Heiss, M, Hennig, M, Moehler, M, Schulze, E, Wimberger, P, Parsons, SL
• Format: Conference Proceeding
• Language: eng ; ger
• ISSN: 0016-5751; 1438-8804
• DOI: 10.1055/s-0032-1309205

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