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.

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.

• Authors: Hiroshi Kitamura, Shiro Hinotsu, Taiji Tsukamoto, Taro Shibata, Junki Mizusawa, Takashi Kobayashi, Makito Miyake, Naotaka Nishiyama, Takahiro Kojima, Hiroyuki Nishiyama, Urologic Oncology Study Group of the Japan Clinical Oncology Group
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 50 Issue 12 Pg. 1464-1469 (Dec 16 2020) ISSN: 1465-3621 [Electronic] England
• PMID: 32699909 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Vinblastine
• Doxorubicin
• Cisplatin
• Methotrexate

Topics

• 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, pathology, surgery)
• Neoadjuvant Therapy
• Quality of Life
• Treatment Outcome
• Urinary Bladder Neoplasms (drug therapy, pathology, surgery)
• Vinblastine (administration & dosage)