HEALTH RELATED QUALITY OF LIFE AND PATIENT REPORTED OUTCOMES IN PATIENTS RECEIVING OFATUMUMAB MAINTENANCE VERSUS OBSERVATION IN THE PROLONG TRIAL

Background
The randomized phase III PROLONG study in 474 relapsed CLL patients in remission after 2^nd or 3^rd line induction treatment has demonstrated a statistically significant improvement in PFS by ofatumumab maintenance treatment  as compared to observation: 29.4 months versus 15.2 months respectively (HR=0.50, p<0.0001; van Oers, 2014).

Aims
However, given that a watch and wait strategy is the current standard of care and patients were treated for up to 24 months with ofatumumab maintenance, it is important to assess the impact of maintenance therapy on health related quality of life (HRQoL).

Methods
During the PROLONG trial, the QLQ-C30 and the QLQ-CLL16 patient questionnaires were administered in all pre-progression patients during both treatment and during the follow up stage. Primary endpoints in patient reported outcomes were health related quality of life as reported by the QLQ-C30 questionnaire and a B-symptom index including patient reported symptoms of fatigue, night sweats, temperature changes and weight loss as reported by the QLQ-C30 and QLQ-CLL16 questionnaires.

Results
In HRQoL, there was no statistical difference (p=0.14) or clinically relevant difference between the arms at any time point measured during treatment with the ofatumumab arm demonstrating a mean 0.2 point decline in HRQoL on a scale of 0-100 and the observational arm demonstrating a mean 1.9 point decline in HRQoL. The B symptom index demonstrated a minor worsening across all B symptoms in patients in the observation arm (p=0.002): during treatment with ofatumumab no change occurred in B symptoms (0.0 on a 0-100 scale) whereas in the  observation arm there was a 2.8 point worsening.  There was a trend to a difference between the arms as to the question about worry for future health, where patients on ofatumumab reported to be less likely to worry (4 point difference on 0-100 scale, p=0.06).

Summary
These results clearly demonstrate that ofatumumab maintenance therapy does   not negatively affect HRQoL. At present it is not known whether the observed differences in the B symptom index and future health score are based on the psychological effects of being treated instead of watchful waiting, or reflect improved quality of remission upon ofatumumab maintenance.

Reference:  van Oers, M, et al. (2014) Ofatumumab (OFA) Maintenance prolongs PFS in Relapsed CLL: PROLONG Study Interim Analysis Results. Blood (ASH Annual Meeting Abstracts),124. Abstract 21

Keyword(s): Quality of life

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