Primary Results of Patient-Reported Outcomes in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with Glofitamab Plus Gemcitabine and Oxaliplatin (Glofit-GemOx) Versus Rituximab Plus GemOx (R-GemOx) from the Phase III Starglo Study
Bibliographic record
Abstract
Background: Patients (pts) with lymphoma have reduced health-related quality of life (HRQoL) due to disease- and treatment-related symptoms, which declines at the time of progression and with further lines of treatment. Glofitamab (Glofit) is the first CD20xCD3 bispecific antibody to demonstrate survival benefit in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in a randomized Phase III trial (STARGLO; NCT04408638). In this study, Glofit-GemOx showed statistically significant benefit in overall and progression-free survival, as well as complete response rate, over R-GemOx in pts with R/R DLBCL who were ineligible for autologous stem cell transplant (Abramson, et al. EHA 2024). Here, we use patient-reported outcomes (PRO) to capture the impact of treatment on HRQoL in pts from the STARGLO trial. Methods: Pts were randomized 2:1 to receive either Glofit-GemOx (8 cycles, plus 4 cycles of Glofit monotherapy) or R-GemOx (8 cycles). HRQoL was measured using the Functional Assessment of Cancer Treatment-Lymphoma Lymphoma Subscale (FACT-Lym LYMS; scale range 0-60; high score = less lymphoma symptoms) for lymphoma symptoms and the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30; scale range 0-100; high score = better functioning and worse symptoms) for functioning and generic symptom scales. Pts completed questionnaires during treatment (Day 1 of Cycles [C]1-5, 7, 9 and 11), at end of treatment (EOT), and every 3 months until death or loss to follow-up. Questionnaire compliance, time to deterioration (TTD), change from baseline (CfB) and summary statistics were estimated at each assessment time point. For TTD analyses, clinically meaningful worsening from baseline for physical functioning (≥10-point decrease), fatigue (≥10-point increase), and lymphoma symptom scores (≥3-point decrease) were reported based on validated thresholds. Results: In total, 274 pts with DLBCL were enrolled (Glofit-GemOx, n=183; R-GemOx, n=91); 172 (62.8%) after 1 prior therapy and 102 (37.2%) after ≥2 prior therapies. Overall, 153 (55.8%) pts had primary refractory disease, and 166 (60.6%) pts were refractory to last therapy. PRO questionnaire response rates were high (>95%) while on treatment. At baseline, pts in both arms reported moderate-to-high functioning, mild impairment in global health status/QoL, and low to low-moderate levels of lymphoma symptoms as assessed by the FACT-Lym LYMS, as well as low-to-mild symptom severity as measured by the EORTC QLQ-C30. The median TTD was comparable between arms (Glofit-GemOx vs R-GemOx) for fatigue (1.6 vs 4.0 months), physical functioning (23.0 vs 18.0 months), and lymphoma symptoms (6.2 vs 4.5 months). At C3, CfB improvements in pain (Glofit-GemOx: −11.38; R-GemOx: −6.67) and lymphoma symptoms (Glofit-GemOx: 3.14; R-GemOx: 0.87) for Glofit-GemOx surpassed the minimal clinically important difference (MCID; pain: −10.0; lymphoma symptoms: 3.0). By C5, improvements continued to surpass the MCID in both arms; mean CfB in the Glofit-GemOx and R-GemOx arms were −12.33 and −12.75 for pain, and 2.27 vs 5.92 for lymphoma symptoms, respectively. At EOT, both arms had sustained improvements in overall pain scores (Glofit-GemOx: 15.94; R-GemOx: 28.04) and lymphoma symptom scores (Glofit-GemOx: 48.78; R-GemOx: 45.13), with pts in the Glofit-GemOx arm reporting less pain and fewer lymphoma symptoms than those in the R-GemOx arm. Conclusions: In the STARGLO study, HRQoL results were comparable between arms, even with a longer treatment period and higher rates of adverse events in the Glofit-GemOx arm. Together with the significant survival benefit conferred on pts with Glofit-GemOx over R-GemOx observed in the STARGLO trial, these HRQoL data further support the use of Glofit-GemOx as a new treatment option for pts with R/R DLBCL.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".