Effect of neoadjuvant chemotherapy on health-related quality of life in patients with muscle-invasive bladder cancer: results from JCOG0209, a randomized phase III study

• Published in: Japanese journal of clinical oncology Vol. 50; no. 12; pp. 1464 - 1469
• Main Authors: Kitamura, Hiroshi, Hinotsu, Shiro, Tsukamoto, Taiji, Shibata, Taro, Mizusawa, Junki, Kobayashi, Takashi, Miyake, Makito, Nishiyama, Naotaka, Kojima, Takahiro, Nishiyama, Hiroyuki
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 16.12.2020
• Subjects: Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cisplatin - administration & dosage; Cystectomy - methods; Doxorubicin - administration & dosage; Female; Humans; Male; Methotrexate - administration & dosage; Middle Aged; Muscle Neoplasms - drug therapy; Muscle Neoplasms - pathology; Muscle Neoplasms - surgery; Neoadjuvant Therapy; Quality of Life; Treatment Outcome; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - surgery; Vinblastine - administration & dosage; patient-reported outcome; neoadjuvant chemotherapy; radical cystectomy; health-related quality of life; bladder cancer
• ISSN: 1465-3621; 1465-3621
• DOI: 10.1093/jjco/hyaa123

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. UMIN Clinical Trials Registry Identifier: C000000093. Although health-related quality of life declined during neoadjuvant methotrexate, vinblastine, doxorubicin and cisplatin, its negative effect was not apparent on health-related quality of life after radical cystectomy and thereafter.