Health-related quality of life in patients with aggressive non-Hodgkin lymphoma: results from the PETAL trial.

When different therapies provide similar cure rates, health-related quality of life (HRQoL) may become crucial for the choice of treatment. In the Positron Emission Tomography-guided Therapy of Aggressive non-Hodgkin Lymphomas (PETAL) trial, we compared six cycles of R-CHOP with or without two extra doses of rituximab in prognostically favorable interim PET (iPET)-negative patients, while eight cycles of R-CHOP were compared with two R-CHOP cycles followed by six cycles of a more intensive protocol in prognostically unfavorable iPET-positive patients. As reported previously, treatment intensification did not improve outcome. HRQoL was assessed using the EORTC QLQ-C30 questionnaire. Pretreatment questionnaires were obtained from 558 out of the 862 participants (64.7%). Pretreatment HRQoL was significantly worse than in the general population. It was associated with age, gender, B symptoms, International Prognostic Index (IPI) and total metabolic tumor volume (TMTV). Physical and cognitive functioning predicted survival independent of IPI or TMTV. During treatment, some domains remained stable (e.g., cognitive functioning, nausea/vomiting), while others improved (e.g., emotional functioning, pain) or deteriorated (e.g., physical functioning, role functioning, fatigue). At the end of treatment, HRQoL was better in patients with controlled disease than in patients with progressive disease and better for iPET-negative patients than for iPET-positive patients. During follow-up, all HRQoL domains returned to levels similar to those reported for the general population. Differences between randomized treatment arms were not observed. The longitudinal data need to be interpreted with caution, because decreasing participation resulted in a selection of patients with increasingly good outcomes. ClinicalTrials.gov no. NCT00554164 (registered 11/5/2007).