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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

  • Naotaka Nishiyama,
  • Hiroshi Kitamura,
  • Shiro Hinotsu,
  • Taiji Tsukamoto,
  • Taro Shibata,
  • Junki Mizusawa,
  • Takashi Kobayashi,
  • Makito Miyake,
  • Takahiro Kojima,
  • Hiroyuki Nishiyama

Research Funding
Health Sciences Research Grants for Medical Frontier Strategy Research from the Ministry of Health, Labour and Welfare of Japan; Health and Labour Sciences Research Grants for Clinical Research for Evidenced-Based Medicine from the Ministry of Health, Lab

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.

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.

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.

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.