Quality of life in advanced‐stage, asymptomatic, non‐bulky follicular lymphoma treated with rituximab shows significant improvement compared with watchful‐waiting

SummaryTraditionally, patients with asymptomatic, advanced‐stage follicular lymphoma were managed with a watchful‐waiting approach until disease progression. The ‘Watch and Wait’ Phase‐3 randomised international trial examined whether rituximab could delay the need for treatment and the effect on quality of life (QoL). In this article, we present the long‐term results of the QoL aspect of the trial. Patients were randomised to watchful‐waiting (Arm A), rituximab induction (Arm B) or rituximab induction followed by maintenance (Arm C). We present the QoL outcomes from 180 patients (Arm A), 188 patients (Arm C) and an exploratory analysis of 82 (Arm B) compared to 81 and 84 patients concurrently randomised to arms A and C. Arm C reported greater improvement in emotional well‐being overtime (Month 37, p = 0.0078) and were significantly more likely to feel in control of their situation than watchful‐waiting patients (Month 25, p = 0.0004; Month 37, p = 0.0476). Watchful‐waiting patients were significantly more likely to avoid thinking about their illness, did not find learning about their illness helped them and were more likely to attach unpleasant connotations to clinic visits (Month 7, p = 0.0032; Month 13, p = 0.0015; Month 25, p = 0.0104). These results demonstrate improved QoL scores in the induction and maintenance rituximab arm, indicating that rituximab was not detrimental to QoL and resulted in an improved QoL in some domains.