Quality of life (qol) in patients with malignant dysphagia receiving radiotherapy alone versus chemoradiotherapy: an international randomized trial: trog (03.01) ncic ctg (es2)

Abstract

Aim: To describe the effect on QoL when CT was added to palliative RT in patients (pts) with incurable esophageal cancer. Methods: 220 pts with malignant dysphagia were randomized to receive RT (30-35 Gy in 10-15 fr) (n = 109) +/- concomitant 5 FU and cisplatin x1 cycle. The primary outcome was dysphagia relief. QoL was evaluated using EORTC QLQ30/OES18 at baseline, wk 9, 13 and mthly x 1 yr. Group mean scores were compared between arms using Wilcoxon Rank-Sum test. Proportion of pts with improved, stable or worsened QoL (>/-10 point change at any time compared with baseline) using chi square and MH chi-square test (for trend) while time to dysphagia improvement was compared using K-M estimates. Results: QoL compliance ranged from 77% (169/220) at baseline to 62% (36/58) at mth12 and was similar between groups. Baseline mean scores were equivalent between arms with the exception of physical [79 (SD19) CRT vs. 83.84 (SD19) RT; p = 0.016] and role domains [61 (SD34) CRT vs. 72 (SD32) RT; p = 0.01]. There was no significant difference in QoL between arms. The proportion of pts with improvement in the dysphagia domain was 50% CRT vs 64% RT (ns) while the time to improvement was 2.6 m CRT vs 2.3 m RT (ns). Similarly, eating domain was improved in 68% CRT and 74% RT (ns). Global QoL was 64% in both arms. Other symptom domains/items that were improved in >50% of pts include pain (62%), and appetite (52%). Functional domain improvements ranged from 41% Emotional, 39% Role, 38% Social, 28% Cognitive to 18% Physical (average of scores in both arms). Conclusion: QoL data showed improvement in domains associated with nutritional intake for 50-70% of pts depending on the symptom measured. This was accompanied by moderate improvement in functional domains. No significant benefit was observed when CT was added to RT alone.