Patient-Reported Outcomes in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Glofitamab plus Gemcitabine and Oxaliplatin in STARGLO

Background The phase III STARGLO study (NCT04408638) demonstrated an overall survival benefit with glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Here, the impact of treatment on patient-reported outcomes (PROs) in STARGLO was evaluated. Materials and Methods Patients were randomized 2:1 to Glofit-GemOx or R-GemOx. PROs were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the Functional Assessment of Cancer Treatment-Lymphoma Lymphoma Subscale throughout treatment and follow-up. Endpoints included time to deterioration (TTD) and change from baseline in functioning and symptoms. Results Overall, 274 patients were enrolled (Glofit-GemOx, n = 183; R-GemOx, n = 91). PRO questionnaire response rates were 100% at baseline and >90% on treatment. Baseline scores indicated moderate-to-high functioning and low-to-moderate symptom severity. Glofit-GemOx had nominal delays in median TTD versus R-GemOx for physical functioning (9.1 vs 8.2 months), fatigue (1.7 vs 1.4 months), and lymphoma symptoms (6.2 vs 4.5 months). Glofit-GemOx-treated patients achieved clinically meaningful improvements in pain and lymphoma symptoms earlier (by Cycle 3) than R-GemOx-treated patients. At end of treatment, pain improvements were maintained in Glofit-GemOx-treated patients, whereas scores for R-GemOx-treated patients returned to pre-treatment baseline. Conclusion Glofit-GemOx maintained health-related quality of life and physical functioning, while providing earlier relief of pain and lymphoma symptoms versus R-GemOx. These findings align with the clinical benefits observed with Glofit-GemOx versus R-GemOx in STARGLO, further supporting Glofit-GemOx as a treatment option for relapsed/refractory DLBCL. Micro-abstract Patient-reported outcomes from STARGLO were evaluated to assess the impact of glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) on health-related quality of life in patients with relapsed/refractory diffuse large B-cell lymphoma. Glofit-GemOx maintained health-related quality of life and physical functioning comparable with R-GemOx, while providing earlier relief of pain and lymphoma-specific symptoms.