Abstract
For advanced Ewing sarcoma (EWS) progression upon first-line chemotherapy, we investigated a novel treatment combination with anti-angiogenesis tyrosine kinase inhibitors (aaTKIs), anlotinib and classic 10-day irinotecan administration strategy in PKUPH-EWS-02. Health-related quality of life (QoL) was an exploratory endpoint in this trial. The objective of this study was to assess dynamic changes in quality of life (QoL) and determine the benefit-risk in terms of quality-adjusted survival for patients using these therapies. QoL was assessed using Questionnaire EORTC QLQ-C30 for adults and PedsQL™ 3.0 Cancer Module for children and adolescents respectively at baseline and at weeks 6, 12, 18, 24 and after progression/off-treatment. The primary QoL endpoint was the dynamic change in QoL scale. The Quality-adjusted Time Without Symptoms of disease progression or Toxicity of treatment (Q-TWiST) analysis was used to describe treatment results. Compliance with HRQoL assessments was good, ranging from 77.78% of off-treatment/progression to 100% at baseline or other periods. During treatment a tendency of improving QoL could be noticed with alleviation of tumor burden whereas after progression a deterioration of QoL would appear. The Intraclass correlation efficient, ICC of PedsQL™ 3.0 Cancer Module showed good to excellent correlation between child self- and parent proxy-reports (range, 0.636-0.908). Like adults, we did not notice any deterioration of QoL during treatment except for progression. Among the descriptive subscales, no reported significantly worse symptom was noticed. QoL had a trend for improvement in accordance with high objective response in this trial with the receipt of combination therapy of anlotinib and irinotecan for advanced Ewing sarcoma. The toxicity profile of anlotinib and irinotecan was reflected in the patients’ self-reported symptoms but did not translate into significantly worse overall scores during treatment.
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