Department of Urology-1, University of Turin, A.O.U. San Giovanni Battista, Turin, Italy.
J Urol. 2013 Sep;190(3):857-62. doi: 10.1016/j.juro.2013.03.097. Epub 2013 Mar 29.
Bacillus Calmette-Guérin and intravesical chemotherapy represent viable adjuvant options for intermediate risk nonmuscle invasive bladder cancer. Although bacillus Calmette-Guérin is perceived as less tolerable than intravesical chemotherapy, to our knowledge no comparative studies have addressed quality of life issues. We compared the quality of life of patients with nonmuscle invasive bladder cancer who received adjuvant intravesical gemcitabine or 1/3 dose bacillus Calmette-Guérin.
Our multicenter, prospective, randomized, phase II study included 120 patients with intermediate risk nonmuscle invasive bladder cancer. Of these patients 88 remained assessable at 1-year followup. Only 1 patient was withdrawn because of adverse events. Overall 61 patients received 2,000 mg/50 cc gemcitabine weekly for 6 weeks (maintenance monthly for 1 year) while 59 received 1/3 dose bacillus Calmette-Guérin Connaught weekly for 6 weeks (maintenance 3 weekly instillations at 3, 6 and 12 months). Quality of life was measured by the EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0) and QLQ-BLS24 (Quality of Life Superficial Bladder Cancer-Specific 24) questionnaires. Group differences were calculated using ANOVA (ANOVA/MANOVA).
Treatment was well tolerated in both groups, although local and systemic side effects were more frequently reported in the bacillus Calmette-Guérin arm. Multivariate analyses showed no significant differences between the 2 groups in all quality of life dimensions. No significant changes over time in quality of life domains were detected for patients on bacillus Calmette-Guérin and gemcitabine except for physical functioning, which decreased significantly in both groups (p = 0.002). No significant differences were detected in terms of recurrence and progression between the 2 groups at 1-year followup.
While a higher rate of side effects, albeit mild to moderate, was detected with 1/3 dose bacillus Calmette-Guérin compared to gemcitabine, our study failed to show significant differences between the 2 drugs in terms of quality of life.
卡介苗和膀胱内化疗是中危非肌肉浸润性膀胱癌的可行辅助治疗选择。虽然卡介苗被认为不如膀胱内化疗耐受，但据我们所知，尚无比较两种治疗方法的生活质量的研究。我们比较了接受辅助性膀胱内吉西他滨或 1/3 剂量卡介苗治疗的非肌肉浸润性膀胱癌患者的生活质量。
我们的多中心、前瞻性、随机、二期研究纳入了 120 例中危非肌肉浸润性膀胱癌患者。其中 88 例患者在 1 年随访时仍可评估。只有 1 例患者因不良事件退出。共有 61 例患者接受每周 2000mg/50cc 吉西他滨治疗 6 周（1 年后每月维持），59 例患者接受每周 1/3 剂量卡介苗康诺特治疗 6 周（3、6 和 12 个月时每 3 周维持 3 次膀胱内灌注）。采用欧洲癌症研究与治疗组织生命质量核心问卷 30 版（EORTC QLQ-C30）和膀胱癌特异性生命质量问卷 24 版（QLQ-BLS24）测量生活质量。采用方差分析（ANOVA/MANOVA）计算组间差异。
两组患者均耐受良好，尽管卡介苗组更常报告局部和全身副作用。多变量分析显示，两组在所有生活质量维度上均无显著差异。除身体功能外，两组患者的生活质量领域在随访期间均无明显变化（p=0.002）。1 年随访时，两组患者的复发和进展无显著差异。
与吉西他滨相比，1/3 剂量卡介苗组虽检测到更高的副作用发生率（虽为轻度至中度），但两种药物在生活质量方面无显著差异。
