Variation in Health-Related Quality of Life by ECOG Performance Status and Fatigue Among Patients with Chronic Lymphocytic Leukemia

Abstract

Abstract 4591 Introduction:Clinicians and investigators appreciate the value of measuring HRQOL for monitoring CLL and the impact of treatments, and commonly use ECOG performance status (PS) and clinician-reported patient fatigue as surrogates for HRQOL in clinical practice. However, limited data exist on the relationships between PS, fatigue, and HRQOL in CLL patients (pts) undergoing treatment in clinical practices. We examined the associations between these measures and 3 psychometrically validated, patient-reported, HRQOL instruments: the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Methods:Data were collected as part of Connect CLL®, a prospective observational registry initiated in March 2010 involving US practices. Data on pt demographics and clinical characteristics were provided by clinicians. HRQOL was self-reported by pts at enrollment using the BFI, EQ-5D, and FACT-Leu. Mean BFI, EQ-5D and FACT-Leu scores were analyzed by ECOG PS and clinician-reported fatigue. Differences in HRQOL scores between sub-cohorts were assessed by ANOVA. Results:HRQOL data were reported by 604 pts enrolled from 10 academic, 148 community, and 3 government centers. Pts were predominantly male (62%) and white (90%); mean age was 70 (standard deviation 11) years. BFI data (scale: 0 [no fatigue] - 10 [worst fatigue]) indicated that on average pts report that global fatigue, fatigue severity and fatigue-related interference worsen by ECOG severity (Table 1) and are statistically associated with clinician-reported fatigue (Table 2). Mean EQ-5D overall HRQOL as measured by a Visual Analogue Scale (VAS) from 0 (worst) to 100 (best) worsens by ECOG severity and is significantly worse in pts with fatigue. Mean EQ-5D domain scores (scale: 1 [no problem], 2 [some problems], 3 [incapacity]) indicated that pain/discomfort, mobility and usual activities increase in severity as ECOG worsens and in pts with fatigue. FACT-Leu domains except social/family were statistically worse with worse ECOG PS and in pts with fatigue.Table 1Baseline HRQOL by ECOG PSHRQOL ScoresECOG PSP-valueECOG 0 (n=218)ECOG 1 (n=221)ECOG 2-4 (n=34)BFI, mean(SD)Global3.5(2.2)4.8(2.4)5.4(2.6)<.0001Severity4.2(2.5)5.6(2.6)6.6(3.0)<.0001Interference3.1(2.3)4.4(2.5)4.8(2.9)<.0001EQ-5DVAS Scale, mean(SD)75.4(21.3)67.8(21.1)60.8(20.7)<.0001Mobility, mean(SD)1.1(0.4)1.3(0.5)1.7(0.6)<.0001Self Care, mean(SD)1.0(0.1)1.1(0.2)1.3(0.5)<.0001Usual Activities, mean(SD)1.3(0.4)1.5(0.5)1.9(0.7)<.0001Pain/Discomfort, mean(SD)1.3(0.5)1.5(0.5)1.6(0.6)<.0001Anxiety/Depression, mean(SD)1.3(0.5)1.3(0.5)1.4(0.5)0.2084FACT-LEU, mean(SD)Physical24.3(3.3)21.6(4.7)18.8(5.9)<.0001Social/Family23.8(5.2)23.2(5.1)21.4(7.2)0.0546Emotional19.4(3.3)19.3(3.8)17.7(4.6)0.0536Functional21.8(5.2)19.0(6.0)15.8(5.5)<.0001CLL subscale Score51.8(8.5)46.8(10.3)43.3(12.0)<.0001FACT-G Total89.3(11.6)83.1(14.3)73.4(18.0)<.0001FACT-LEU Total141.0(17.6)129.9(22.2)116.4(26.8)<.0001Table 2Baseline HRQOL Scores by Clinician-Reported Constitutional Symptom: FatigueHRQOL ScoresFatigueYes (n=318)No (n=286)P-valueBFI, mean(SD)Global5.0(2.4)3.6(2.3)<.0001Severity5.9(2.5)4.1(2.5)<.0001Interference4.5(2.5)3.3(2.5)<.0001EQ-5DVAS Scale, mean(SD)66.5(20.5)75.0(21.1)<.0001Mobility, mean(SD)1.4(0.5)1.2(0.4)<.0001Self Care, mean(SD)1.1(0.3)1.0(0.2)0.0151Usual Activities, mean(SD)1.5(0.6)1.3(0.5)<.0001Pain/Discomfort, mean(SD)1.5(0.5)1.4(0.5)0.0288Anxiety/Depression, mean(SD)1.4(0.5)1.3(0.5)0.0408FACT-LEU, mean(SD)Physical21.3(4.7)23.6(4.3)<.0001Social/Family23.1(5.0)23.7(5.7)0.1524Emotional18.8(3.8)19.4(3.4)0.0951Functional18.8(5.9)20.9(6.0)<.0001CLL subscale Score46.2(10.0)51.4(10.0)<.0001FACT-G Total82.0(14.2)87.7(14.2)<.0001FACT-LEU Total128.3(21.9)139.1(21.8)<.0001 Conclusions:Initial results from Connect CLL® indicate that HRQOL worsens with worsening ECOG PS, especially in physical / functioning domains, pain/discomfort, and mobility, and worsens across multiple domains among pts whose physicians reported fatigue. Future analyses should be conducted on how HRQOL, PS and fatigue may change over time with changes in CLL, and how they are influenced by therapies. These results may serve as baseline reference. Disclosures:Pashos:Celgene: Membership on an entity's Board of Directors or advisory committees. Flowers:Genentech/Roche (unpaid): Consultancy; Celgene: Consultancy; Millennium/Takeda: Research Funding; Wyeth: Research Funding; Novartis: Research Funding. Weiss:Celgene: Membership on an entity's Board of Directors or advisory committees. Lamanna:Celgene: Membership on an entity's Board of Directors or advisory committees. Farber:Celgene: Membership on an entity's Board of Directors or advisory committees. Kipps:Igenica: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Research Funding; Abbot Industries: Research Funding; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; GSK: Research Funding; Gilead Sciences: Consultancy, Research Funding; Amgen: Research Funding. Lerner:Celgene: Membership on an entity's Board of Directors or advisory committees. Kay:Celgene: Membership on an entity's Board of Directors or advisory committees. Sharman:Celgene: Membership on an entity's Board of Directors or advisory committees. Grinblatt:Celgene: Membership on an entity's Board of Directors or advisory committees. Flinn:Celgene: Membership on an entity's Board of Directors or advisory committees. Kozloff:Celgene: Membership on an entity's Board of Directors or advisory committees. Swern:Celgene Corporation: Employment, Equity Ownership. Kahn:Celgene Corporation: Employment, Equity Ownership. Street:Celgene: Employment, Equity Ownership. Sullivan:Celgene: Employment, Equity Ownership. Keating:Celgene: Membership on an entity's Board of Directors or advisory committees.