Work ability is a critical economic and well-being indicator in cancer care. Yet, work ability is understudied in clinical trials and observational research and is often undocumented in medical records. Despite agreement on the importance of work from well-being, health insurance, and financial perspectives, standardized approaches for collecting, measuring, and analyzing work outcomes are lacking in the health care setting. The necessary components for closing the gap in patient and caregiver employment research in health care settings involve a common set of measures, including those that replace or translate generic measures of mental and physical functioning into work outcomes in observational and clinical trial research, standardized approaches to data collection and documentation, and the use of longitudinal data to understand the consequences of reduced work ability over time. We present a conceptual framework for the inclusion of work ability in outcomes research. We cover constructs for employment and work ability measurement that can be adopted in research, recorded as patient-level data, and used to guide treatment decisions. The inclusion of return to work and hours worked, productivity, and ability to perform in a similar job can support conversations that guide treatment decisions and minimize economic consequences. Our hope is that by considering impact on work ability, improved treatments will be developed, health inequities reduced, and resources will be directed toward aiding patients and their caregivers in balancing work and health demands.
{"title":"Much work to do about measuring work","authors":"Cathy J Bradley, Sara Kitchen, Kelsey M Owsley","doi":"10.1093/jnci/djad258","DOIUrl":"https://doi.org/10.1093/jnci/djad258","url":null,"abstract":"Work ability is a critical economic and well-being indicator in cancer care. Yet, work ability is understudied in clinical trials and observational research and is often undocumented in medical records. Despite agreement on the importance of work from well-being, health insurance, and financial perspectives, standardized approaches for collecting, measuring, and analyzing work outcomes are lacking in the health care setting. The necessary components for closing the gap in patient and caregiver employment research in health care settings involve a common set of measures, including those that replace or translate generic measures of mental and physical functioning into work outcomes in observational and clinical trial research, standardized approaches to data collection and documentation, and the use of longitudinal data to understand the consequences of reduced work ability over time. We present a conceptual framework for the inclusion of work ability in outcomes research. We cover constructs for employment and work ability measurement that can be adopted in research, recorded as patient-level data, and used to guide treatment decisions. The inclusion of return to work and hours worked, productivity, and ability to perform in a similar job can support conversations that guide treatment decisions and minimize economic consequences. Our hope is that by considering impact on work ability, improved treatments will be developed, health inequities reduced, and resources will be directed toward aiding patients and their caregivers in balancing work and health demands.","PeriodicalId":501635,"journal":{"name":"Journal of the National Cancer Institute","volume":"111 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138559384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David W Cescon, Peter Schmid, Hope S Rugo, Seock-Ah Im, Mastura Md Yusof, Carlos Gallardo, Oleg Lipatov, Carlos H Barrios, Jose Perez-Garcia, Hiroji Iwata, Norikazu Masuda, Marco Torregroza Otero, Erhan Gokmen, Sherene Loi, Amin Haiderali, Xuan Zhou, Zifang Guo, Allison Martin Nguyen, Javier Cortes
Background In KEYNOTE-355 (NCT02819518), addition of pembrolizumab to chemotherapy led to statistically significant improvements in progression-free survival and overall survival in patients with advanced triple-negative breast cancer (TNBC) with tumor PD-L1 combined positive score (CPS) ≥10. We report patient-reported outcomes (PROs) from KEYNOTE-355. Methods Patients were randomized 2:1 to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus investigator’s choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin). QLQ-C30, QLQ-BR23, and EQ-5D visual analogue scale (VAS) were prespecified. PROs were analyzed for patients who received ≥1 dose of study treatment and completed ≥1 PRO assessment. Change in PRO scores from baseline were assessed at week 15 (latest time point at which completion/compliance rates were ≥60%/≥80%). Time to deterioration (TTD) in PROs was defined as time to first onset of ≥ 10-point worsening in score from baseline. Results PRO analyses included 317 patients with tumor PD-L1 CPS ≥10 (pembrolizumab plus chemotherapy; n = 217; placebo plus chemotherapy, n = 100). There were no between-group differences in change from baseline to week 15 in QLQ-C30 global health status/quality of life (GHS/QoL; least-squares mean difference, −1.81 [95% CI, −6.92 to 3.30]), emotional functioning (−1.43 [−7.03 to 4.16]), physical functioning (−1.05 [−6.59 to 4.50]), or EQ-5D VAS (0.18 [−5.04 to 5.39]), and no between-group difference in TTD in QLQ-C30 GHS/QoL, emotional functioning, or physical functioning. Conclusions Together with the efficacy and safety findings, PRO results from KEYNOTE-355 support pembrolizumab plus chemotherapy as a standard of care for patients with advanced TNBC with tumor PD-L1 (CPS ≥10).
{"title":"Health-Related Quality of Life With Pembrolizumab+Chemotherapy Versus Placebo+Chemotherapy for Advanced Triple-Negative Breast Cancer: KEYNOTE-355","authors":"David W Cescon, Peter Schmid, Hope S Rugo, Seock-Ah Im, Mastura Md Yusof, Carlos Gallardo, Oleg Lipatov, Carlos H Barrios, Jose Perez-Garcia, Hiroji Iwata, Norikazu Masuda, Marco Torregroza Otero, Erhan Gokmen, Sherene Loi, Amin Haiderali, Xuan Zhou, Zifang Guo, Allison Martin Nguyen, Javier Cortes","doi":"10.1093/jnci/djad240","DOIUrl":"https://doi.org/10.1093/jnci/djad240","url":null,"abstract":"Background In KEYNOTE-355 (NCT02819518), addition of pembrolizumab to chemotherapy led to statistically significant improvements in progression-free survival and overall survival in patients with advanced triple-negative breast cancer (TNBC) with tumor PD-L1 combined positive score (CPS) ≥10. We report patient-reported outcomes (PROs) from KEYNOTE-355. Methods Patients were randomized 2:1 to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus investigator’s choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin). QLQ-C30, QLQ-BR23, and EQ-5D visual analogue scale (VAS) were prespecified. PROs were analyzed for patients who received ≥1 dose of study treatment and completed ≥1 PRO assessment. Change in PRO scores from baseline were assessed at week 15 (latest time point at which completion/compliance rates were ≥60%/≥80%). Time to deterioration (TTD) in PROs was defined as time to first onset of ≥ 10-point worsening in score from baseline. Results PRO analyses included 317 patients with tumor PD-L1 CPS ≥10 (pembrolizumab plus chemotherapy; n = 217; placebo plus chemotherapy, n = 100). There were no between-group differences in change from baseline to week 15 in QLQ-C30 global health status/quality of life (GHS/QoL; least-squares mean difference, −1.81 [95% CI, −6.92 to 3.30]), emotional functioning (−1.43 [−7.03 to 4.16]), physical functioning (−1.05 [−6.59 to 4.50]), or EQ-5D VAS (0.18 [−5.04 to 5.39]), and no between-group difference in TTD in QLQ-C30 GHS/QoL, emotional functioning, or physical functioning. Conclusions Together with the efficacy and safety findings, PRO results from KEYNOTE-355 support pembrolizumab plus chemotherapy as a standard of care for patients with advanced TNBC with tumor PD-L1 (CPS ≥10).","PeriodicalId":501635,"journal":{"name":"Journal of the National Cancer Institute","volume":"74 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138559382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Meredith S Shiels, Barry I Graubard, Timothy S McNeel, Lisa Kahle, Neal D Freedman
Background In the U.S., lung cancer death rates have declined for decades, primarily due to pronounced decreases in cigarette smoking. However, it is unclear whether there have been similar declines in mortality rates of lung cancer unrelated to smoking. We estimated trends in U.S. lung cancer death rates attributable and not attributable to smoking from 1991-2018. Methods The study included 30-79-year-olds in the National Health Interview Survey who were linked to the National Death Index, 1991-2014. Adjusted hazard ratios (HRs) for smoking status and lung cancer death were estimated, and age-specific population attributable fractions (PAFs) were calculated. Annual PAFs were multiplied by annual U.S. national lung cancer mortality, partitioning rates into smoking-attributable and smoking-unrelated lung cancer deaths. All statistical tests were two-sided. Results During 1991-2018, the proportion of never smokers increased among both men (35.1% to 54.6%) and women (54.0% to 65.4%). Compared to ever smokers, never smokers had 86% lower risk (HR = 0.14; 95%CI 0.12, 0.16) of lung cancer death. The fraction of lung cancer deaths attributable to smoking decreased from 81.4% (95%CI 78.9, 81.4) to 74.7% (95%CI 78.1, 71.4). Smoking-attributable lung cancer death rates declined 2.7%/year (95%CI -2.9, -2.5) and smoking-unrelated lung cancer death rates declined 1.8%/year (95%CI -2.0, -1.5); these declines accelerated in recent years. Conclusions An increasing proportion of lung cancer deaths are unrelated to smoking, due to declines in smoking prevalence. However, smoking-unrelated lung cancer death rates have declined, perhaps due to decreases in secondhand smoke and air pollution exposure and treatment improvements.
{"title":"Trends in smoking-attributable and smoking-unrelated lung cancer death rates in the U.S., 1991-2018","authors":"Meredith S Shiels, Barry I Graubard, Timothy S McNeel, Lisa Kahle, Neal D Freedman","doi":"10.1093/jnci/djad256","DOIUrl":"https://doi.org/10.1093/jnci/djad256","url":null,"abstract":"Background In the U.S., lung cancer death rates have declined for decades, primarily due to pronounced decreases in cigarette smoking. However, it is unclear whether there have been similar declines in mortality rates of lung cancer unrelated to smoking. We estimated trends in U.S. lung cancer death rates attributable and not attributable to smoking from 1991-2018. Methods The study included 30-79-year-olds in the National Health Interview Survey who were linked to the National Death Index, 1991-2014. Adjusted hazard ratios (HRs) for smoking status and lung cancer death were estimated, and age-specific population attributable fractions (PAFs) were calculated. Annual PAFs were multiplied by annual U.S. national lung cancer mortality, partitioning rates into smoking-attributable and smoking-unrelated lung cancer deaths. All statistical tests were two-sided. Results During 1991-2018, the proportion of never smokers increased among both men (35.1% to 54.6%) and women (54.0% to 65.4%). Compared to ever smokers, never smokers had 86% lower risk (HR = 0.14; 95%CI 0.12, 0.16) of lung cancer death. The fraction of lung cancer deaths attributable to smoking decreased from 81.4% (95%CI 78.9, 81.4) to 74.7% (95%CI 78.1, 71.4). Smoking-attributable lung cancer death rates declined 2.7%/year (95%CI -2.9, -2.5) and smoking-unrelated lung cancer death rates declined 1.8%/year (95%CI -2.0, -1.5); these declines accelerated in recent years. Conclusions An increasing proportion of lung cancer deaths are unrelated to smoking, due to declines in smoking prevalence. However, smoking-unrelated lung cancer death rates have declined, perhaps due to decreases in secondhand smoke and air pollution exposure and treatment improvements.","PeriodicalId":501635,"journal":{"name":"Journal of the National Cancer Institute","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138559385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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