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Predictive and Prognostic Significance of Patient-Reported Outcomes for Survival and Adverse Events in
Ahmad Y Abuhelwa1,2,3, Sara A Almansour1, Ethan Basch4
1Department of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, UAE.
Objectives:
Patient-reported outcomes (PROs), including physical function, have predictive potential for survival but remain underexplored in multiple myeloma (MM). This study evaluates the predictive and prognostic value of PROs for treatment outcomes in MM patients on daratumumab-based therapy and evaluates physical function versus ECOG Performance Status as a potential treatment-effect modifier.
Methods:
Data was pooled from randomized trials (MAIA, POLLUX, CASTOR) that collected pretreatment PROs using EORTC QLQ-C30. Cox models and logistic regression examined associations between PROs and overall survival (OS), progression-free survival (PFS) and grade ≥ 3 adverse events. Physical function versus ECOG-PS was examined as a treatment effect modifier for daratumumab versus non-daratumumab therapies.
Results:
Among 1804 patients, 1535 (85%) had pretreatment PROs. Physical function, global health, and fatigue were most prognostic for survival and adverse events. Physical function provided independent prognostic value beyond ECOG-PS and was predictive of treatment effect. Low physical function patients experienced greater OS treatment benefit (adjusted HR (aHR) [95% CI] 0.53 [0.40-0.70], p interaction = 0.02) and PFS (aHR [95% CI] 0.30 [0.30-0.48], p interaction = 0.03) from daratumumab versus high-physical function (OS aHR 0.86 [0.62-1.19], PFS aHR 0.53 [0.42-0.67]).
Conclusion:
Physical function is a predictive and prognostic marker that complements ECOG-PS, supporting its use in informing therapy decisions for daratumumab-based treatments.
Insights
Patient-reported physical function is a key predictor of survival and treatment response in multiple myeloma (MM). This finding supports its use alongside ECOG Performance Status in guiding daratumumab therapy decisions.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Patient-reported outcomes (PROs), including physical function, are important prognostic indicators in multiple myeloma (MM) but are understudied.
- Understanding PROs' role can optimize treatment strategies and patient outcomes.
Purpose of the Study:
- To evaluate the predictive and prognostic value of PROs for treatment outcomes in MM patients receiving daratumumab-based therapy.
- To compare the utility of physical function with ECOG Performance Status (ECOG-PS) as a treatment-effect modifier.
Main Methods:
- Pooled data from randomized trials (MAIA, POLLUX, CASTOR) including 1804 MM patients.
- Pretreatment PROs were collected using EORTC QLQ-C30.
- Cox models and logistic regression analyzed associations between PROs, overall survival (OS), progression-free survival (PFS), and adverse events. Physical function and ECOG-PS were assessed as treatment effect modifiers.
Main Results:
- Physical function, global health, and fatigue were most prognostic for survival and adverse events.
- Physical function independently predicted outcomes beyond ECOG-PS.
- Patients with low physical function showed significantly greater OS and PFS benefits from daratumumab therapy compared to those with high physical function.
Conclusions:
- Physical function is a valuable predictive and prognostic marker in MM.
- It complements ECOG-PS and should be considered in treatment decisions for daratumumab-based therapies.
