scholarly journals Health-related quality of life (HRQoL) and updated follow-up from KEYNOTE-057: Phase II study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG)

2019 ◽  
Vol 30 ◽  
pp. v364-v365 ◽  
Author(s):  
R. de Wit ◽  
G.S. Kulkarni ◽  
E. Uchio ◽  
J.L. Boormans ◽  
M. Roumiguié ◽  
...  
2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17006-e17006
Author(s):  
Naotaka Nishiyama ◽  
Hiroshi Kitamura ◽  
Shiro Hinotsu ◽  
Taiji Tsukamoto ◽  
Taro Shibata ◽  
...  

e17006 Background: Although neoadjuvant chemotherapy (NAC) provides survival benefits in muscle-invasive bladder cancer (MIBC), the impact of NAC on health-related quality of life (HRQoL) has not been investigated by a randomized trial. The purpose of this study is to compare HRQoL in patients with MIBC who received NAC followed by radical cystectomy (RC) or RC alone based on patient-reported outcome data. Methods: Patients were randomized to receive 2 cycles of neoadjuvant methotrexate, doxorubicin, vinblastine, and cisplatin (MVAC) followed by RC or RC alone. HRQoL was measured using the Functional Assessment of Cancer Therapy – Bladder (FACT-BL, version 4) questionnaire before the protocol treatments, after NAC, after RC, and one year after registration. Results: A total of 99 patients were analyzed. No statistically significant differences in postoperative HRQoL were found between the arms. In the NAC arm, the scores after NAC were significantly lower than the baseline scores in physical well-being, functional well-being, FACT-General total, weight loss, diarrhea, appetite, body appearance, embarrassment by ostomy appliance, and total FACT-BL. However, there was no difference in scores for these domains, except for embarrassment by ostomy appliance, between the two arms after RC and one year after registration. Conclusions: Although HRQoL declined during NAC, no negative effect of NAC on HRQoL was apparent after RC. These data support the view that NAC can be considered as a standard of care for patients with MIBC regarding HRQoL. Clinical trial information: C000000093.


2008 ◽  
Vol 15 (5) ◽  
pp. 403-406 ◽  
Author(s):  
Katsuyoshi Hashine ◽  
Noriyoshi Miura ◽  
Kousaku Numata ◽  
Akitomi Shirato ◽  
Yoshiteru Sumiyoshi ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030396
Author(s):  
Liesbeth de Goeij ◽  
Ellen Westhoff ◽  
J Alfred Witjes ◽  
Katja KH Aben ◽  
Ellen Kampman ◽  
...  

IntroductionPatients with non-muscle-invasive bladder cancer (NMIBC) have a good survival but are at high risk for tumour recurrence and disease progression. It is important to identify lifestyle habits that may reduce the risk of recurrence and progression and improve health-related quality of life (HRQOL). This paper describes the rationale and design of the UroLife study. The main aim of this study is to evaluate whether lifestyle habits are related to prognosis and HRQOL in patients with NMIBC.Methods and analysisThe UroLife study is a multicentre prospective cohort study among more than 1100 newly diagnosed patients with NMIBC recruited from 22 hospitals in the Netherlands. At 6 weeks and 3, 15 and 51 months after diagnosis, participants fill out a general questionnaire, and questionnaires about their lifestyle habits and HRQOL. At 3, 15 and 51 months after diagnosis, information about fluid intake and micturition is collected with a 4-day diary. At 3 and 15 months after diagnosis, patients donate blood samples for DNA extraction and (dietary) biomarker analysis. Tumour samples are collected from all patients with T1 disease to assess molecular subtypes. Information about disease characteristics and therapy for the primary tumour and subsequent recurrences is collected from the medical records by the Netherlands Cancer Registry. Statistical analyses will be adjusted for age, gender, tumour characteristics and other known confounders.Ethics and disseminationThe study protocol has been approved by the Committee for Human Research region Arnhem-Nijmegen (CMO 2013-494). Patients who agree to participate in the study provide written informed consent. The findings from our study will be disseminated through peer-reviewed scientific journals and presentations at (inter)national scientific meetings. Patients will be informed about the progress and results of this study through biannual newsletters and through the website of the study and of the bladder cancer patient association.


2020 ◽  
Vol 50 (12) ◽  
pp. 1464-1469
Author(s):  
Hiroshi Kitamura ◽  
Shiro Hinotsu ◽  
Taiji Tsukamoto ◽  
Taro Shibata ◽  
Junki Mizusawa ◽  
...  

Abstract Background Although neoadjuvant chemotherapy provides survival benefits in muscle-invasive bladder cancer, the impact of neoadjuvant chemotherapy on health-related quality of life has not been investigated by a randomized trial. The purpose of this study is to compare health-related quality of life in patients with muscle-invasive bladder cancer who received neoadjuvant chemotherapy followed by radical cystectomy or radical cystectomy alone based on patient-reported outcome data. Methods Patients were randomized to receive two cycles of neoadjuvant methotrexate, doxorubicin, vinblastine, and cisplatin followed by radical cystectomy or radical cystectomy alone. Health-related quality of life was measured using the Functional Assessment of Cancer Therapy-Bladder (version 4) questionnaire before the protocol treatments, after neoadjuvant chemotherapy, after radical cystectomy and 1 year after registration. Results A total of 99 patients were analysed. No statistically significant differences in postoperative health-related quality of life were found between the arms. In the neoadjuvant chemotherapy arm, the scores after neoadjuvant chemotherapy were significantly lower than the baseline scores in physical well-being, functional well-being, Functional Assessment of Cancer Therapy-General total, weight loss, diarrhoea, appetite, body appearance, embarrassment by ostomy appliance and total Functional Assessment of Cancer Therapy-Bladder. However, there was no difference in scores for these domains, except for embarrassment by ostomy appliance, between the two arms after radical cystectomy and 1 year after registration. Conclusions Although health-related quality of life declined during neoadjuvant chemotherapy, no negative effect of neoadjuvant chemotherapy on health-related quality of life was apparent after radical cystectomy. These data support the view that neoadjuvant chemotherapy can be considered as a standard of care for patients with muscle-invasive bladder cancer regarding health-related quality of life.


2019 ◽  
Vol 125 (1) ◽  
pp. 38-48 ◽  
Author(s):  
Ahrang Jung ◽  
Matthew E. Nielsen ◽  
Jamie L. Crandell ◽  
Mary H. Palmer ◽  
Sophia K. Smith ◽  
...  

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