Dalbagni Guido, Russo Paul, Bochner Bernard, Ben-Porat Leah, Sheinfeld Joel, Sogani Pramod, Donat Machelle S, Herr Harry W, Bajorin Dean
Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Clin Oncol. 2006 Jun 20;24(18):2729-34. doi: 10.1200/JCO.2005.05.2720.
The aim of this phase II study was to determine the efficacy of gemcitabine administered as an intravesical agent in patients with bacille Calmette-Guérin (BCG) -refractory transitional cell carcinoma of the bladder.
Patients with superficial bladder cancer refractory or intolerant to intravesical BCG therapy and refusing a cystectomy were considered eligible for the trial. Eligible patients received two courses of intravesical gemcitabine twice weekly at a dose of 2,000 mg/100 mL for 3 consecutive weeks, with each course separated by 1 week of rest. Patients were evaluated for response at 8 weeks, then every 3 months to 1 year.
Thirty eligible patients were included on study. The median follow-up for all the patients was 19 months (range, 0 to 35 months). Of the 30 patients, 15 (50%; 95% CI, 32% to 68%) achieved a complete response (CR). Twelve patients had tumor recurrence with a median recurrence-free survival time of 3.6 months (95% CI, 2.9 to 11.0 months). Two patients maintained a CR at 23 and 29 months, respectively. The 1-year recurrence-free survival rate for patients with a CR was 21% (95% CI, 0% to 43%). Two patients progressed to a higher stage while receiving gemcitabine treatment. The median follow-up for patients who did not have a progression or a cystectomy was 19 months (range, 2 to 35 months). Eleven patients (37%) underwent a cystectomy subsequent to gemcitabine therapy.
Gemcitabine has activity in a high-risk patient population and remains a viable option for some patients who refuse cystectomy.
本II期研究的目的是确定吉西他滨作为膀胱内给药药物，用于卡介苗（BCG）难治性膀胱移行细胞癌患者的疗效。
对膀胱内卡介苗治疗难治或不耐受且拒绝膀胱切除术的浅表性膀胱癌患者进行试验。符合条件的患者接受两个疗程的膀胱内吉西他滨治疗，每周两次，剂量为2000mg/100mL，连续3周，每个疗程间隔1周休息。在8周时对患者进行反应评估，然后每3个月至1年评估一次。
30名符合条件的患者纳入研究。所有患者的中位随访时间为19个月（范围0至35个月）。30名患者中，15名（50%；95%CI，32%至68%）达到完全缓解（CR）。12名患者出现肿瘤复发，无复发生存时间中位数为3.6个月（95%CI，2.9至11.0个月）。两名患者分别在23个月和29个月时维持完全缓解。完全缓解患者的1年无复发生存率为21%（95%CI，0%至43%）。两名患者在接受吉西他滨治疗时病情进展至更高分期。未进展或未接受膀胱切除术患者的中位随访时间为19个月（范围2至35个月）。11名患者（37%）在吉西他滨治疗后接受了膀胱切除术。
吉西他滨在高危患者群体中具有活性，对于一些拒绝膀胱切除术的患者仍然是一个可行的选择。
