Quality of life (QoL) in patients with malignant dysphagia: An international randomized trial comparing radiotherapy alone (RT) versus chemoradiotherapy (CRT)—TROG03.01 NCICCTG ES2.

Abstract

163 Background: The dominant symptom for pts with esophageal cancer is dysphagia. Palliative radiotherapy is commonly employed for symptom relief. We report the effect on QoL in our study comparing a 2-3 week course of RT alone vs the same RT with a single cycle of concomitant CT. Methods: 220 pts with malignant dysphagia were randomized to receive RT (30-35Gy in 10-15 fr) (n=109) ± concomitant CT (5FU and cisplatin D1-4) cycle. The primary outcome was dysphagia relief. QoL was evaluated using EORTC QLQ30/OES18 at baseline, wk 9, 13 and mthly x1yr. 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 the arms. The proportion of pts with improvement in the dysphagia domain was 50% CRT vs 64% RT (ns) while the time to improvement was 2.6m CRT vs 2.3m RT (ns). The eating domain was improved in 68% CRT and 74% RT (ns) while global QoL was 46% in both arms. Other symptom domains/items that were improved in more than half of the pts included 62% in pain and 52% in appetite. Functional domain improvements were moderate ranging from 41% emotional, 39% role, 38% social, 28% cognitive to 18% physical (average of scores in both arms). Conclusions: 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. Clinical trial information: NCT00193882.