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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

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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. / Wimberger, P; Gilet, H; Gonschior, A-K; Heiss, M M; Moehler, M; Oskay-Oezcelik, G; Al-Batran, S-E; Schmalfeldt, B; Schmittel, A; Schulze, E; Parsons, S L.

In: ANN ONCOL, Vol. 23, No. 8, 08.2012, p. 1979-85.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Wimberger, P, Gilet, H, Gonschior, A-K, Heiss, MM, Moehler, M, Oskay-Oezcelik, G, Al-Batran, S-E, Schmalfeldt, B, Schmittel, A, Schulze, E & Parsons, SL 2012, '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', ANN ONCOL, vol. 23, no. 8, pp. 1979-85. https://doi.org/10.1093/annonc/mds178

APA

Wimberger, P., Gilet, H., Gonschior, A-K., Heiss, M. M., Moehler, M., Oskay-Oezcelik, G., Al-Batran, S-E., Schmalfeldt, B., Schmittel, A., Schulze, E., & Parsons, S. L. (2012). 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. ANN ONCOL, 23(8), 1979-85. https://doi.org/10.1093/annonc/mds178

Vancouver

Wimberger P, Gilet H, Gonschior A-K, Heiss MM, Moehler M, Oskay-Oezcelik G et al. 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. ANN ONCOL. 2012 Aug;23(8):1979-85. https://doi.org/10.1093/annonc/mds178

Bibtex

@article{589ff67caffe4fdbb509c15d3558d3f0,
title = "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.",
keywords = "Adult, Aged, Aged, 80 and over, Antibodies, Bispecific, Antigens, Neoplasm, Ascites, Cell Adhesion Molecules, Combined Modality Therapy, Female, Humans, Male, Middle Aged, Neoplasms, Ovarian Neoplasms, Paracentesis, Proportional Hazards Models, Quality of Life, Young Adult",
author = "P Wimberger and H Gilet and A-K Gonschior and Heiss, {M M} and M Moehler and G Oskay-Oezcelik and S-E Al-Batran and B Schmalfeldt and A Schmittel and E Schulze and Parsons, {S L}",
year = "2012",
month = aug,
doi = "10.1093/annonc/mds178",
language = "English",
volume = "23",
pages = "1979--85",
journal = "ANN ONCOL",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "8",

}

RIS

TY - JOUR

T1 - 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

AU - Wimberger, P

AU - Gilet, H

AU - Gonschior, A-K

AU - Heiss, M M

AU - Moehler, M

AU - Oskay-Oezcelik, G

AU - Al-Batran, S-E

AU - Schmalfeldt, B

AU - Schmittel, A

AU - Schulze, E

AU - Parsons, S L

PY - 2012/8

Y1 - 2012/8

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antibodies, Bispecific

KW - Antigens, Neoplasm

KW - Ascites

KW - Cell Adhesion Molecules

KW - Combined Modality Therapy

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Neoplasms

KW - Ovarian Neoplasms

KW - Paracentesis

KW - Proportional Hazards Models

KW - Quality of Life

KW - Young Adult

U2 - 10.1093/annonc/mds178

DO - 10.1093/annonc/mds178

M3 - SCORING: Journal article

C2 - 22734013

VL - 23

SP - 1979

EP - 1985

JO - ANN ONCOL

JF - ANN ONCOL

SN - 0923-7534

IS - 8

ER -