Transurethral resection with perioperative instillation of interferon-α or epirubicin for the prophylaxis of recurrent primary superficial bladder cancer:: A prospective randomized multicenter study -: Finnbladder III
Transurethral resection with perioperative instillation of interferon-α or epirubicin for the prophylaxis of recurrent primary superficial bladder cancer:: A prospective randomized multicenter study -: Finnbladder III
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DOI：
10.1016/s0022-5347(01)61609-4
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发表时间：
1999-04-01
影响因子：
6.6
通讯作者：
Lukkarinen, O
中科院分区：
文献类型：
--
作者：
Rajala, P;Liukkonen, T;Lukkarinen, O
目的：我们评估了经尿道切除术后立即给予单剂量干扰素或表阿霉素与仅经尿道切除术对原发性膀胱癌复发的疗效。（非复发性）浅表性膀胱癌。共有283例Ta至T1期原发性浅表性1至3级膀胱癌患者被随机分为研究组1-仅经尿道切除术，2-经尿道切除术加5000万单位干扰素-α 2b和3-经尿道切除术加100 mg，表阿霉素。有资格进行最终分析的患者为200例，包括第1组66例、第2组66例和第3组68例。患者随访膀胱镜检查，每3个月为2 years或直到初始recurrent.Results：组3有最有利的结果，因为45的68例（66%）是没有复发后2年相比，24的66（37%）在组2和26的66（40%）在组1（对数秩检验P < 0.001）。不良反应多为轻度和一过性，各组间无差异。经尿道切除术后立即膀胱内给予一定剂量的表阿霉素是安全的，并可显著降低原发性浅表性膀胱癌的复发率。5000万单位剂量的干扰素-α 2b耐受性良好，但单次剂量对复发没有影响。这种治疗的长期效果还有待研究。
Purpose: We evaluated the efficacy of single dose of interferon or epirubicin administered immediately after transurethral resection compared with transurethral resection only on the recurrence of primary (not recurrent) superficial bladder cancer.Materials and Methods: A total of 283 patients with stages Ta to T1 primary superficial, grades 1 to 3 bladder cancer was randomized into study groups 1--transurethral resection only, 2-transurethral resection plus 50 million units interferon-alpha 2b and 3-transurethral resection plus 100 mg, epirubicin. Eligible for final analysis were 200 patients, including 66 in group 1, 66 in group 2 and 68 in group 3. Patients were followed with cystoscopy every 3 months for 2 years or until the initial recurrence.Results: Group 3 had the most favorable outcome, since 45 of the 68 patients (66%) were without recurrence after 2 years compared to 24 of the 66 (37%) in group 2 and 26 of the 66 (40%) in group 1 (log rank test p < 0.001). Side effects were mostly mild and transient, and no differences were found among the groups.Conclusions: A single 100 mg. dose of epirubicin given intravesically immediately after transurethral resection is safe, and significantly decreases the recurrence of primary superficial bladder cancer. A 50 million unit dose of interferon-alpha 2b is well tolerated but it has no effect on recurrence as a single dose. The long-term effect of this treatment remains to be studied.