OBJECTIVES: Evaluate the impact of N+R on the health-related quality of life (HRQL) of R/R DLBCL patients using the FACT-Lym questionnaire and mapped EQ-5D values.

METHODS: FACT-Lym was administered in a Phase II single-arm trial of N+R to patients in two cohorts, on weekly and every-3-week dosing schedules, prior to treatment and at each subsequent cycle. The FACT-Lym questionnaire includes the Functional Assessment of Cancer Therapy – General (FACT-G), along with the GP5 item, “I am bothered by side effects of treatment” [“Not at all” (0) – “Very much” (4)]. It also contains a lymphoma-specific subscale (Lyms), which generates a score of 0-60, with higher scores indicating better HRQL. We pooled both cohorts to compare changes in the FACT-Lym from baseline to end of treatment (EOT) between responders (complete/partial tumor response) and non-responders. Finally, the FACT-Lym scores were mapped to EQ-5D values using published algorithms.

RESULTS: By EOT, 27% of responders vs. 10% of non-responders had significant improvement at the individual level of 6 points on the Lyms. For the FACT-Lym Trial Outcome Index (TOI: FACT-G physical and functional well-being + Lyms), 36% of responders vs. 10% of non-responders had a significant improvement of 7 points. Responders had a significantly lower probability of deterioration on the Lyms and TOI across the trial follow-up (p<0.001). At EOT, only 1 (9%) responder and 4 (19%) non-responders reported high side effect bother ("very much"/"quite a bit") on the GP5 item. At baseline, the mean estimated EQ-5D utility index scores for responders vs. non-responders were 0.78 vs. 0.73, while at EOT these were 0.77 vs. 0.67.

CONCLUSIONS: N+R responders were more likely to improve and less likely to decline in their HRQL. At the same time, side effect bother was not increased for N+R responders. These values are strong signals of N+R efficacy and favourable tolerability.