UNDERSTANDING PRO RESPONSIVENESS TO CHANGE: LONGITUDINAL CONSTRUCT VALIDITY OF EORTC CORE QUALITY OF LIFE QUESTIONNAIRE (QLQ-C30) GLOBAL HEALTH STATUS/QUALITY OF LIFE (GHS/QOL) AND PAIN SCORES IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER...
Author(s)
Neo Su, MPH, MS, PharmD1, Adrian Jewett, MA2, Melissa Kirker, PharmD MPH3, Jane Chang, MPH4, Paul Cislo, PhD4, Fong Wang, MD PhD4, Arne Engelsberg, MD PhD4, Brandon Foster, PhD5, Andrew BOTTOMLEY, PhD6.
1Pfizer, Houston, TX, USA, 2Lumanity, Glendale, CA, USA, 3Pfizer, Washington, DC, USA, 4Pfizer, New York, NY, USA, 5Lumanity, Wakefield, MA, USA, 6Bottomley Consulting Group, overjise, Belgium.
1Pfizer, Houston, TX, USA, 2Lumanity, Glendale, CA, USA, 3Pfizer, Washington, DC, USA, 4Pfizer, New York, NY, USA, 5Lumanity, Wakefield, MA, USA, 6Bottomley Consulting Group, overjise, Belgium.
OBJECTIVES: TALAPRO-2 evaluated talazoparib plus enzalutamide (TALA+ENZA) in mCRPC. EORTC QLQ-C30 scores were collected to assess PROs, encompassing change from baseline across GHS/QoL, functioning, and symptoms scales. This analysis investigated the responsiveness of QLQ-C30 GHS/QoL and Pain scales by assessing whether change scores corresponded with changes in related QoL and pain measures in mCRPC patients.
METHODS: Spearman correlations between change scores in QLQ-C30 GHS/QoL and Pain and change scores in co-validating measures were estimated. GHS/QoL co-validators included change in QLQ-C30 Physical Functioning, Role Functioning, Fatigue, and Pain, alongside Brief Pain Inventory-Short Form (BPI-SF) Pain Interference and Item 3 (worst pain in last 24 hours). Pain co-validators included change in EQ-5D-5L Pain/Discomfort, BPI-SF Pain Interference, and worst pain. Moderate (~|0.30|) to large correlations (≥|0.50|) were expected. Correlations were pooled across visits using weighted means.
RESULTS: Among the 395 patients (TALA+ENZA PRO population), correlations were consistent with expectations. Change in GHS/QoL demonstrated moderate associations with co-validators: Physical Functioning 0.35 (range 0.23 to 0.46), Role Functioning 0.33 (range 0.23 to 0.49), Fatigue −0.36 (range −0.48 to −0.23), QLQ-C30 Pain −0.29 (range −0.42 to −0.19). Associations with BPI-SF Pain Interference (−0.27) and worst pain (−0.25) were similar. Change in QLQ-C30 Pain exhibited large correlations with pain co-validators: EQ-5D-5L Pain/Discomfort 0.57 (range 0.43 to 0.70), BPI-SF Pain Interference 0.58 (range 0.42 to 0.67), worst pain 0.59 (range 0.47 to 0.72).
CONCLUSIONS: In TALAPRO-2, change in QLQ-C30 GHS/QoL and Pain scores correlated meaningfully with related PROs, providing evidence of responsiveness in measuring changes in mCRPC patients. GHS/QoL reflected broader changes in key functioning and common symptoms in mCRPC, reinforcing its utility in clinical trials as a QoL measure to inform clinical practice and HTA/regulatory decisions. The QLQ-C30 Pain scale aligned closely with BPI-SF pain interference and worst pain, measures commonly used to evaluate pain in regulatory contexts.
METHODS: Spearman correlations between change scores in QLQ-C30 GHS/QoL and Pain and change scores in co-validating measures were estimated. GHS/QoL co-validators included change in QLQ-C30 Physical Functioning, Role Functioning, Fatigue, and Pain, alongside Brief Pain Inventory-Short Form (BPI-SF) Pain Interference and Item 3 (worst pain in last 24 hours). Pain co-validators included change in EQ-5D-5L Pain/Discomfort, BPI-SF Pain Interference, and worst pain. Moderate (~|0.30|) to large correlations (≥|0.50|) were expected. Correlations were pooled across visits using weighted means.
RESULTS: Among the 395 patients (TALA+ENZA PRO population), correlations were consistent with expectations. Change in GHS/QoL demonstrated moderate associations with co-validators: Physical Functioning 0.35 (range 0.23 to 0.46), Role Functioning 0.33 (range 0.23 to 0.49), Fatigue −0.36 (range −0.48 to −0.23), QLQ-C30 Pain −0.29 (range −0.42 to −0.19). Associations with BPI-SF Pain Interference (−0.27) and worst pain (−0.25) were similar. Change in QLQ-C30 Pain exhibited large correlations with pain co-validators: EQ-5D-5L Pain/Discomfort 0.57 (range 0.43 to 0.70), BPI-SF Pain Interference 0.58 (range 0.42 to 0.67), worst pain 0.59 (range 0.47 to 0.72).
CONCLUSIONS: In TALAPRO-2, change in QLQ-C30 GHS/QoL and Pain scores correlated meaningfully with related PROs, providing evidence of responsiveness in measuring changes in mCRPC patients. GHS/QoL reflected broader changes in key functioning and common symptoms in mCRPC, reinforcing its utility in clinical trials as a QoL measure to inform clinical practice and HTA/regulatory decisions. The QLQ-C30 Pain scale aligned closely with BPI-SF pain interference and worst pain, measures commonly used to evaluate pain in regulatory contexts.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR132
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology