ArticleBMC medical research methodology2025
Matching plus regression adjustment for the estimation of the average treatment effect on survival outcomes: a case study with mosunetuzumab in relapsed/refractory follicular lymphoma.
Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma
A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Who cites it
1 citing paper in PubMed.
- Mosunetuzumab: A bispecific CD20 × CD3 antibody for follicular lymphoma with promising evidence in other B-NHL subtypes.Human vaccines & immunotherapeutics · 2026Review
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesThe National Institute for Health and Care Excellence (England's health technology assessment body) recommend the use of the average treatment effect (ATE) as an estimand for economic evaluations. However there is limited literature on methods to estimate the ATE, particularly in the case of survival outcomes. Single-arm trials and real-world data are playing an increasing role in health technology assessments, particularly in oncology/rare diseases, generating a need for new ATE estimation methods. This study aimed to present the adaptation and utility of this methodology for survival outcomes.
methodsThe approach is based on a "doubly robust" method combining matching with regression adjustment (Austin 2020) using a Weibull model (lowest Akaike information criteria [AIC] specification) to estimate counterfactual event times. As a case study, we compared mosunetuzumab versus rituximab/bendamustine, as a proxy for rituximab/chemotherapy, in 3L+ relapsed/refractory follicular lymphoma. Individual patient data for mosunetuzumab (NCT02500407) and a combination of two rituximab/bendamustine 3L+ follicular lymphoma cohorts (NCT02187861/NCT02257567) were used. Endpoints included overall survival (OS) and progression-free survival (PFS). Sensitivity analyses were performed to test robustness to different distributional assumptions (log-normal, log-logistic and exponential) or model specifications (second, third and fourth lowest AIC) for event times.
resultsThe case study found improved PFS (hazard ratio [HR] 0.43 [95% confidence interval (CI): 0.13, 0.91]) and OS (HR 0.30 [95% CI: 0.05, 5.28]) for mosunetuzumab. Consistent findings (HR range 0.25-0.47 and 0.21-0.50 with all CIs excluding/including 1 for PFS/OS, respectively) were observed in sensitivity analyses. DISCUSSION/
conclusionsThe proposed adaptation expands the range of available approaches for the estimation of the (local) ATE for survival outcomes in health technology assessments using "doubly robust" methods. This approach appeared relatively robust to modelling decisions in our case study.
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Registered trials
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