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

Abstract

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.

Patients and 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.

Trial registration: ClinicalTrials.gov NCT00836654.

Figure 1

Flow chart of analysis sets. FAS, full analysis set; SAS, safety analysis set; FQoLAS, full QoL analysis set; SQoLAS, safety QoL analysis set.

Figure 2

Time to first deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) scores of primary interest, in days (full QoL analysis set, FQoLAS). Box for each score: interquartile range (Q1–Q3); +: mean; –: median; bottom and top bars: observed minimum and maximum values; ○: outliers (i.e. values that are outside the distance of 1.5 times the interquartile range from Q1 or Q3). Note: patients censored: n = 112–133 for catumaxomab, n = 53–70 for control.

Figure 3

Kaplan–Meier curve and log-rank test for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) scores of primary interest (full QoL analysis set, FQoLAS).