Health-Related Quality-of-Life Assessment of Obinutuzumab plus Bendamustine versus Bendamustine in Patients with Rituximab-Refractory Indolent NHL: Results of the GADOLIN Study
Health-related quality of life (HRQoL) is an important treatment end point for patients with indolent non-Hodgkin lymphoma (NHL). Obinutuzumab (GA101) is a glycoengineered anti-CD20 monoclonal antibody that is being evaluated in patients with rituximab-refractory indolent NHL. GADOLIN is a phase 3 study of obinutuzumab (GA101) plus bendamustine versus bendamustine alone in patients with CD20+ rituximab-refractory patients with indolent NHL. Primary results of the GADOLIN trial demonstrated a significant prolongation of median progression-free survival (PFS) with obinutuzumab/bendamustine therapy compared with control (median PFS: not reached vs 14.9 months; hazard ratio [HR], 0.55; P = .0001), with an acceptable safety profile.1 At ASH 2015, Cheson and colleagues presented patient-reported HRQoL data from the GADOLIN trial.2
In the trial, patient HRQoL in terms of overall physical and functional well-being, and disease- and treatment-related symptoms were assessed using the Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) questionnaire that was administered on day 1 of cycles 1, 3, and 5 during treatment; at the end of induction treatment, and every other month for 2 years; and during follow-up. Time to 6-point worsening from baseline in the FACT-Lym Trial Outcome Index (TOI) was estimated for each treatment group. Minimally important differences at the individual subscale and total score levels were used to define the proportion of patients reporting improvement on the FACT-Lym lymphoma subscale (3 points), TOI (6 points), and lymphoma total score (7 points).
The study findings were that patients treated with obinutuzumab/bendamustine achieved a longer time to clinically meaningful deterioration of lymphoma-related HRQoL compared with those treated with bendamustine alone, with a time to 6-point worsening from baseline of 8.0 months versus 4.6 months (HR, 0.74). In addition, a greater proportion of patients treated with obinutuzumab/bendamustine reported meaningful improvement on the lymphoma subscale, lymphoma TOI, and total score versus the control; this improvement was documented throughout the study and occurred even during the induction phase. Based on these results, the authors concluded that the observed PFS improvements did not occur at the expense of increased treatment-related toxicity and consequent decreased HRQoL.
- Sehn LH, et al. ASCO 2015. Abstract LBA8502.
- Cheson B, et al. ASH 2015. Abstract 1532.