The Breast 23 (2014) 763e769
Contents lists available at ScienceDirect
The Breast journal homepage: www.elsevier.com/brst
Original article
Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort study Charles S. Cleeland a, *, Musa Mayer b, Nancy A. Dreyer c, Yeun Mi Yim d, Elaine Yu d, Zhaohui Su c, Yong Mun d, Jeff A. Sloan e, Peter A. Kaufman f a
MD Anderson Cancer Center, Houston, TX, United States AdvancedBC.org, New York, NY, United States Real-World & Late Phase Research, Quintiles, Cambridge, MA, United States d Genentech, Inc., South San Francisco, CA, United States e Mayo Clinic Cancer Center, Rochester, MN, United States f Norris Cotton Cancer Center, Lebanon, NH, United States b c
a r t i c l e i n f o
a b s t r a c t
Article history: Received 6 May 2014 Received in revised form 24 July 2014 Accepted 7 August 2014 Available online 3 September 2014
Limited data exist on the association of symptom burden, daily activity impairment, and work productivity (WP) in patients with advanced breast cancer. This cross-sectional analysis evaluated baseline patient-reported outcomes (PROs) in patients with locally recurrent or metastatic breast cancer (MBC) receiving first-line hormonal therapy or chemotherapy and/or targeted therapy in the VIRGO observational study. The primary PRO study endpoint, symptom severity and interference score, was measured using the MD Anderson Symptom Inventory (MDASI). Secondary endpoints included Activity Level Scale (ALS), health-related quality of life (HRQOL), and Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) scores. Overall, 152 patients (chemotherapy cohort, 104; hormonal therapy cohort, 48) answered questionnaires. Fatigue, decreased sexual interest, disturbed sleep, emotional distress, and drowsiness were the most common severe symptoms, and were of moderate-to-severe intensity in 38.8% e52.0% of patients. Mean percent daily activity impairment was 30% for study patients, and WP impairment ranged from 20% to 40% across indices in employed patients (n, 58). Significant positive correlations existed for MDASI severity and interference scores with activity impairment and WP indices (Pearson correlation coefficients [R] ¼ 0.47e0.82; p < 0.0001). ALS and overall HRQOL correlated negatively with these indices (R ¼ 0.41 to 0.60; p 0.001). After adjustment for potential confounders, MDASI symptom interference and ALS were significant predictors of activity and WP impairment. Our results indicate patients receiving treatment for MBC are symptomatic with significant daily activity and/or WP impairment. Symptom severity and interference, functional status, and overall HRQOL were moderately correlated with perceived work-related ability. © 2014 Published by Elsevier Ltd.
Keywords: Breast neoplasms Work Symptom assessment Quality of life
Introduction Clinical studies have indicated that the majority of patients surviving non-metastatic breast cancer (MBC) resume work activities post treatment, although the unemployment rate in this population appears to be higher than in healthy controls [1,2]. In
* Corresponding author. The University of Texas MD Anderson Cancer Center, Department of Symptom Research, 1515 Holcombe Boulevard, Unit 1450, Houston, TX 77030, USA. Tel.: þ1 713 745 3470; fax: þ1 713 745 3475. E-mail address: [email protected] (C.S. Cleeland). http://dx.doi.org/10.1016/j.breast.2014.08.004 0960-9776/© 2014 Published by Elsevier Ltd.
general, breast cancer survivors experience work limitations and productivity loss even several years after concluding treatment for stage IeIII disease [3e6]. Work productivity (WP) in breast cancer survivors has been inversely correlated with disease stage (I versus II) and the presence of residual symptoms, such as fatigue [3]. Limited data are available on patient experience and measures of perceived work-related ability (daily activity and WP) in advanced disease. However, therapeutic advances in the last decade have improved outcomes in MBC, allowing many patients to return to daily activities, including work. Given that approximately 59% of women with breast cancer are
Contents lists available at ScienceDirect
The Breast journal homepage: www.elsevier.com/brst
Original article
Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort study Charles S. Cleeland a, *, Musa Mayer b, Nancy A. Dreyer c, Yeun Mi Yim d, Elaine Yu d, Zhaohui Su c, Yong Mun d, Jeff A. Sloan e, Peter A. Kaufman f a
MD Anderson Cancer Center, Houston, TX, United States AdvancedBC.org, New York, NY, United States Real-World & Late Phase Research, Quintiles, Cambridge, MA, United States d Genentech, Inc., South San Francisco, CA, United States e Mayo Clinic Cancer Center, Rochester, MN, United States f Norris Cotton Cancer Center, Lebanon, NH, United States b c
a r t i c l e i n f o
a b s t r a c t
Article history: Received 6 May 2014 Received in revised form 24 July 2014 Accepted 7 August 2014 Available online 3 September 2014
Limited data exist on the association of symptom burden, daily activity impairment, and work productivity (WP) in patients with advanced breast cancer. This cross-sectional analysis evaluated baseline patient-reported outcomes (PROs) in patients with locally recurrent or metastatic breast cancer (MBC) receiving first-line hormonal therapy or chemotherapy and/or targeted therapy in the VIRGO observational study. The primary PRO study endpoint, symptom severity and interference score, was measured using the MD Anderson Symptom Inventory (MDASI). Secondary endpoints included Activity Level Scale (ALS), health-related quality of life (HRQOL), and Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) scores. Overall, 152 patients (chemotherapy cohort, 104; hormonal therapy cohort, 48) answered questionnaires. Fatigue, decreased sexual interest, disturbed sleep, emotional distress, and drowsiness were the most common severe symptoms, and were of moderate-to-severe intensity in 38.8% e52.0% of patients. Mean percent daily activity impairment was 30% for study patients, and WP impairment ranged from 20% to 40% across indices in employed patients (n, 58). Significant positive correlations existed for MDASI severity and interference scores with activity impairment and WP indices (Pearson correlation coefficients [R] ¼ 0.47e0.82; p < 0.0001). ALS and overall HRQOL correlated negatively with these indices (R ¼ 0.41 to 0.60; p 0.001). After adjustment for potential confounders, MDASI symptom interference and ALS were significant predictors of activity and WP impairment. Our results indicate patients receiving treatment for MBC are symptomatic with significant daily activity and/or WP impairment. Symptom severity and interference, functional status, and overall HRQOL were moderately correlated with perceived work-related ability. © 2014 Published by Elsevier Ltd.
Keywords: Breast neoplasms Work Symptom assessment Quality of life
Introduction Clinical studies have indicated that the majority of patients surviving non-metastatic breast cancer (MBC) resume work activities post treatment, although the unemployment rate in this population appears to be higher than in healthy controls [1,2]. In
* Corresponding author. The University of Texas MD Anderson Cancer Center, Department of Symptom Research, 1515 Holcombe Boulevard, Unit 1450, Houston, TX 77030, USA. Tel.: þ1 713 745 3470; fax: þ1 713 745 3475. E-mail address: [email protected] (C.S. Cleeland). http://dx.doi.org/10.1016/j.breast.2014.08.004 0960-9776/© 2014 Published by Elsevier Ltd.
general, breast cancer survivors experience work limitations and productivity loss even several years after concluding treatment for stage IeIII disease [3e6]. Work productivity (WP) in breast cancer survivors has been inversely correlated with disease stage (I versus II) and the presence of residual symptoms, such as fatigue [3]. Limited data are available on patient experience and measures of perceived work-related ability (daily activity and WP) in advanced disease. However, therapeutic advances in the last decade have improved outcomes in MBC, allowing many patients to return to daily activities, including work. Given that approximately 59% of women with breast cancer are
