Abstract

Abstract 3926

Introduction.

Chronic lymphocytic leukemia (CLL) patients will have significant variation in signs and symptoms at initial presentation and across lines of therapy, with concomitant effect on patient health-related quality of life (HRQOL). HRQOL and other patient-reported outcomes, together with clinical outcomes, provide a more complete perspective on the burden of disease and facilitate a broader view of the impact of treatment regimens. This analysis evaluates whether the HRQOL of patients with CLL in the United States (US) varies at the time the patients are about to embark on various lines of therapy, and offers a baseline report from which subsequent longitudinal analysis post-treatment will be possible.

Methods.

Clinical and HRQOL data were collected in Connect®CLL, a prospective observational registry initiated in March 2010 involving centers in the US. Physicians provided data on the demographics and clinical characteristics of patients receiving therapy. HRQOL was self-reported by patients at enrollment using the Brief Fatigue Inventory (BFI, a symptom assessment tool), the EQ-5D (a non-disease-specific HRQOL instrument), and the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu, a leukemia-specific HRQOL instrument). We characterized patients who had initial (First Line), second (Second Line) or subsequent (Higher Line) treatment regimens prior to initiation of regimens. Reported mean overall and/or domain-specific BFI, EQ-5D and FACT-Leu scores were analyzed by line of therapy. Statistical significance of score differences among sub-cohorts was ascertained by ANOVA using SAS 9.1.

Results.

Evaluable data were reported on 1005 patients, enrolled from 161 centers (93% community, 7% academic). Patients were predominantly male (62%) and white (89%) with mean age at 69 (standard deviation [SD] 11) years. HRQOL scores by line of therapy are presented:

HRQOL ScoresFirst line (n=633)Second line (n=197)Higher line (n=175)P-value
BFI Mean (SD)     
    Global 4.1 (2.4) 4.3 (2.4) 4.2 (2.4) 0.0423* 
    Severity 4.9 (2.7) 5.1 (2.8) 4.9 (2.5) 0.0181* 
    Interference 3.7 (2.5) 3.9 (2.5) 3.9 (2.6) 0.1007 
EQ-5D, mean (SD)     
    Index overall 0.87 (0.14) 0.84 (0.15) 0.83 (0.15) 0.0195* 
    VAS overall 73.8 (19.6) 70.7 (19.9) 69.8 (18.5) 0.0232* 
    Mobility domain 1.2 (0.4) 1.3 (0.5) 1.3 (0.5) 0.0091* 
    Self Care domain 1.0 (0.2) 1.1 (0.3) 1.1 (0.2) 0.1453 
    Usual Activities domain 1.4 (0.5) 1.5 (0.6) 1.4 (0.6) 0.1280 
    Pain/Discomfort domain 1.4 (0.5) 1.5 (0.6) 1.5 (0.5) 0.0049* 
    Anxiety/Depression domain 1.3 (0.5) 1.3 (0.5) 1.4 (0.5) 0.7132 
FACT-LEU Mean(SD)     
    Physical 22.9 (4.4) 22.2 (4.9) 22.0 (5.3) 0.0129* 
    Social/Family 23.8 (4.8) 23.6 (5.1) 22.6 (5.8) 0.0819 
    Emotional 19.2 (3.7) 19.5 (3.6) 18.7 (3.9) 0.1820 
    Functional 19.9 (5.9) 19.5 (6.0) 19.1 (6.6) 0.4145 
    Leukemia subscale 50.2 (9.6) 48.9 (10.9) 47.3 (11.1) 0.0023* 
    FACT-G Total 85.8 (13.9) 84.6 (14.1) 82.5 (15.9) 0.0372* 
    FACT-LEU Total 136.3 (21.7) 133.4 (22.7) 129.8 (25.1) 0.0039* 
HRQOL ScoresFirst line (n=633)Second line (n=197)Higher line (n=175)P-value
BFI Mean (SD)     
    Global 4.1 (2.4) 4.3 (2.4) 4.2 (2.4) 0.0423* 
    Severity 4.9 (2.7) 5.1 (2.8) 4.9 (2.5) 0.0181* 
    Interference 3.7 (2.5) 3.9 (2.5) 3.9 (2.6) 0.1007 
EQ-5D, mean (SD)     
    Index overall 0.87 (0.14) 0.84 (0.15) 0.83 (0.15) 0.0195* 
    VAS overall 73.8 (19.6) 70.7 (19.9) 69.8 (18.5) 0.0232* 
    Mobility domain 1.2 (0.4) 1.3 (0.5) 1.3 (0.5) 0.0091* 
    Self Care domain 1.0 (0.2) 1.1 (0.3) 1.1 (0.2) 0.1453 
    Usual Activities domain 1.4 (0.5) 1.5 (0.6) 1.4 (0.6) 0.1280 
    Pain/Discomfort domain 1.4 (0.5) 1.5 (0.6) 1.5 (0.5) 0.0049* 
    Anxiety/Depression domain 1.3 (0.5) 1.3 (0.5) 1.4 (0.5) 0.7132 
FACT-LEU Mean(SD)     
    Physical 22.9 (4.4) 22.2 (4.9) 22.0 (5.3) 0.0129* 
    Social/Family 23.8 (4.8) 23.6 (5.1) 22.6 (5.8) 0.0819 
    Emotional 19.2 (3.7) 19.5 (3.6) 18.7 (3.9) 0.1820 
    Functional 19.9 (5.9) 19.5 (6.0) 19.1 (6.6) 0.4145 
    Leukemia subscale 50.2 (9.6) 48.9 (10.9) 47.3 (11.1) 0.0023* 
    FACT-G Total 85.8 (13.9) 84.6 (14.1) 82.5 (15.9) 0.0372* 
    FACT-LEU Total 136.3 (21.7) 133.4 (22.7) 129.8 (25.1) 0.0039* 

P-value from ANOVA among three groups.

*

Statistically significant at 0.05.

The total FACT-Leu and FACT-G results, and the total EQ-5D Index and Visual Analogue Scale (VAS) results, consistently suggest that patients initiating first line therapy have somewhat better HRQOL compared with those initiating subsequent lines of therapy. FACT-Leu total scores of patients initiating first line therapy were associated with better physical and leukemia-specific considerations, and the EQ-5D total score was associated with better mobility and pain/discomfort.

Conclusions.

Initial results from the Connect® CLL Registry indicate that HRQOL prior to treatment is better among patients initiating first line therapy compared to patients initiating later lines of treatment. Future analyses should be conducted to determine what clinical or other factors may be associated with the HRQOL deterioration in patients initiating subsequent lines of therapy, so as to inform clinician decision making. Also, subsequent longitudinal analyses should be undertaken to determine how HRQOL might be affected by the different lines of therapy and the specific treatment regimens, as well as by their initial HRQOL and other patient factors.

Disclosures:

Kay:Celgene: Research Funding. Flowers:Celgene: Consultancy; Prescription Solutions: Consultancy; Seattle Genetics: Consultancy; Millennium: Research Funding, Unpaid consultancy, Unpaid consultancy Other; Genentech: Unpaid consultancy, Unpaid consultancy Other; Gilead: Research Funding; Spectrum: Research Funding; Janssen lymphoma research foundation: Membership on an entity's Board of Directors or advisory committees. Weiss:Celgene: Consultancy. Lamanna:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Flinn:Celgene: Research Funding. Grinblatt:Celgene: Honoraria, Speakers Bureau. Kipps:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Kozloff:Celgene: Consultancy. Lerner:Celgene Connect: Membership on an entity's Board of Directors or advisory committees. Sharman:Celgene: Consultancy; Pharmacyclics: Honoraria; Calistoga: Honoraria; Portola pharmaceuticals: Consultancy. Khan:Celgene Corporation: Employment, Equity Ownership. Street:Celgene: Employment, Equity Ownership. Swern:Celgene: Employment. Sullivan:Celgene: Employment. Pashos:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Author notes

*

Asterisk with author names denotes non-ASH members.