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A Randomized Controlled Clinical Trial of Palliative Therapies for Patients With Inoperable Esophageal Cancer: Clinical Trial of Palliative Therapies

Lookup NU author(s): Dr Jonathan Shenfine, Paul McNamee, Dr Nick Steen, Professor John Bond, Professor Michael Griffin

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Abstract

OBJECTIVES: A dramatic rise in incidence, an aging population, and expensive palliative treatments have led to an escalating burden on clinicians managing inoperable esophageal cancer with only limited evidence of effectiveness. This study compares the clinical effectiveness and cost-effectiveness of self-expanding metal stents (SEMSs) with other palliative therapies to aid clinicians in making an evidence-based treatment choice. METHODS: We conducted a prospective, multicenter, randomized, controlled, clinical trial with 215 patients followed until death or study closure. The primary outcome measures were dysphagia, quality of life (QL) 6 weeks following treatment, and total cost of treatment. Secondary outcome measures included treatment-associated morbidity, mortality, survival, and cost-effectiveness. An intention-to-treat analysis was carried out. RESULTS: There was a significant difference in mean dysphagia grade between treatment arms 6 weeks following treatment (P = 0.046), with worse swallowing reported by rigid stent-treated patients (mean dysphagia score difference = -0.49; 95% confidence interval (CI)-0.10 to -0.89, P = 0.014). Global QL scores were lower at both 1 and 6 weeks following treatment for patients treated by SEMSs (mean difference QL index week 1 = -0.66; 95% CI: -0.02 to -1.30, P = 0.04; mean difference QL index week 6 = -1.01; 95% CI-0.30 to -1.72, P = 0.006). These findings were associated with higher post-procedure pain scores in the SEMS patient group (mean difference of the European Organisation for Research and Treatment of Cancer QLQ C-30 pain symptom score at week 1 = 11.13; 95% CI: 2.89-19.4; P = 0.01). Although mean EQ-5D QL values differed between the treatments (P

Publication metadata

Author(s): Shenfine J, McNamee P, Steen N, Bond J, Griffin SM

Publication type: Article

Publication status: Published

Journal: American Journal of Gastroenterology

Year: 2009

Volume: 104

Issue: 7

Pages: 1674-1685

ISSN (print): 0002-9270

ISSN (electronic): 1572-0241

Publisher: Nature Publishing Group

URL: http://dx.doi.org/10.1038/ajg.2009.155

DOI: 10.1038/ajg.2009.155

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