BACKGROUND BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer, demonstrated improvement of local control and bladder cancer-specific survival from the addition of concomitant 5-fluorouracil and mitomycin C to radiotherapy. OBJECTIVE To determine the impact of treatment on the health-related quality of life (HRQoL) of BC2001 participants. DESIGN, SETTING, AND PARTICIPANTS 458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder. INTERVENTION Patients were randomised to the chemotherapy comparison (radiotherapy, 178, or chemoradiotherapy, 182); and/or to the radiotherapy comparison (standard, 108, or reduced high-dose volume radiotherapy, 111). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Patients completed Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires at baseline, end of treatment (EoT), and 6, 12, 24, 36, 48, and 60 months after radiotherapy. The primary endpoint was change from baseline in the bladder cancer subscale (BLCS) at 12 months. RESULTS AND LIMITATIONS Data were available for 331 (92%) and 204 (93%) participants at baseline and for 192 (54%) and 114 (52%) at 12 months for the chemotherapy and radiotherapy comparisons, respectively. HRQoL declined at EoT (BLCS -5.06 [99% confidence interval: -6.12 to -4.00, p< 0.001]; overall FACT-B TOTAL score -8.22 [-10.76 to -5.68, p< 0.01]), recovering to baseline at 6 months and remaining similar to baseline subsequently. There was no significant difference between randomised groups at any time point. CONCLUSIONS Immediately following (chemo)radiotherapy, a significant proportion of patients report declines in HRQoL, which improve to baseline after 6 months. Two-thirds of patients report stable or improved HRQoL on long-term follow-up. There is no evidence of impairment in HRQoL resulting from the addition of chemotherapy. PATIENT SUMMARY Quality of life of bladder cancer patients treated with radiotherapy±chemotherapy deteriorates during treatment, but improves to at least pretreatment levels within 6 months. Addition of chemotherapy to radiotherapy does not affect patient-reported quality of life.

中文翻译：

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BC2001 III 期随机对照试验中接受放疗±化疗治疗肌层浸润性膀胱癌的患者报告的生活质量结果。


背景 BC2001 是针对肌层浸润性膀胱癌保留膀胱治疗的最大随机试验，证明在放射治疗中同时添加 5-氟尿嘧啶和丝裂霉素 C 可以改善局部控制和膀胱癌特异性生存。目的 确定治疗对 BC2001 参与者健康相关生活质量 (HRQoL) 的影响。设计、设置和参与者 458 名患有 T2-T4a N0 M0 膀胱移行细胞癌的英国患者。干预 患者被随机分配进行化疗比较（放疗，178 名，或放化疗，182 名）；和/或放疗比较（标准，108，或减少的高剂量体积放疗，111）。结果测量和统计分析 患者在基线、治疗结束 (EoT) 以及放疗后 6、12、24、36、48 和 60 个月时完成了癌症治疗功能评估-膀胱 (FACT-BL) 问卷。主要终点是 12 个月时膀胱癌分量表 (BLCS) 相对于基线的变化。结果和局限性 基线时有 331 名 (92%) 和 204 名 (93%) 参与者的数据可供使用，12 个月时分别有 192 名 (54%) 和 114 名 (52%) 参与者的数据可用于化疗和放疗比较。 HRQoL 在 EoT 时下降（BLCS -5.06 [99% 置信区间：-6.12 至 -4.00，p< 0.001]；总体 FACT-B 总分 -8.22 [-10.76 至 -5.68，p< 0.01]），恢复至基线6 个月，随后保持与基线相似。在任何时间点，随机分组之间都没有显着差异。结论 在（化疗）放疗后，很大一部分患者报告 HRQoL 下降，6 个月后改善至基线。 三分之二的患者报告长期随访后 HRQoL 稳定或改善。没有证据表明加用化疗会导致 HRQoL 受损。患者概要 接受放疗±化疗的膀胱癌患者的生活质量在治疗期间恶化，但在 6 个月内至少改善至治疗前的水平。在放疗中加入化疗不会影响患者报告的生活质量。