Reporting health-related quality of life in randomised clinical trials evaluating adjuvant systemic therapy: recommendations of Common-Sense Oncology and the European Organisation for Research and Treatment of Cancer.

The goal of adjuvant systemic therapy after locoregional treatment of cancer is to increase the probability of cure by eradicating micro-metastases. Adjuvant treatment adds side-effects and can impair health-related quality of life (HRQOL); this must be balanced against a reduction in the probability of recurrence, which has a substantial negative effect on HRQOL. Since many adjuvant therapies lead to small gains in relapse-free or overall survival, the severity and duration of treatment-related side-effects and their impact on patient functioning and overall HRQOL are relevant to clinical decision making. To facilitate understanding by oncologists and patients, we recommend reporting in publications the proportion of patients receiving adjuvant therapy who experience a prespecified deterioration in a relevant and validated HRQOL scale, and the duration of this deterioration during and after treatment completion, with appropriate handling of missing data and intercurrent events. HRQOL assessment should include symptoms, functioning domains, and overall HRQOL. Between-group comparisons should address key HRQOL outcomes (as defined by both oncologists and patients) supplemented by descriptive outcomes across remaining HRQOL domains. Once the proportion of patients with specific adverse changes in symptoms is identified, it is possible to determine if specific patient group(s) are at particular risk for these effects. HRQOL information should be included in the primary report of trials evaluating adjuvant therapy as it is key to informed decisions about treatment choice, and updated long-term evaluation is also important to capture any lasting deficits in HRQOL.