INTRAVESICAL BACILLUS-CALMETTE-GUERIN THERAPY PREVENTS TUMOR PROGRESSION AND DEATH FROM SUPERFICIAL BLADDER-CANCER - 10-YEAR FOLLOW-UP OF A PROSPECTIVE RANDOMIZED TRIAL
INTRAVESICAL BACILLUS-CALMETTE-GUERIN THERAPY PREVENTS TUMOR PROGRESSION AND DEATH FROM SUPERFICIAL BLADDER-CANCER - 10-YEAR FOLLOW-UP OF A PROSPECTIVE RANDOMIZED TRIAL
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DOI：
10.1200/jco.1995.13.6.1404
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发表时间：
1995-06-01
影响因子：
45.3
通讯作者：
OETTGEN, HF
中科院分区：
文献类型：
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作者：
HERR, HW;SCHWALB, DM;OETTGEN, HF
目的：浅表性膀胱肿瘤（Ta、T1和Tis期）可能进展为侵袭膀胱肌肉并导致转移性癌症死亡。经尿道肿瘤切除术（TURB）是此类肿瘤的标准治疗方法，但单独手术可能无法阻止肿瘤进展。膀胱内灌注治疗被广泛用作TURB的辅助治疗。卡介苗（BCG）是最活跃的膀胱内剂，但是否BCG阻止肿瘤进展和死亡膀胱cancer.Patients和方法：在1978年和1981年之间，86例高危浅表性膀胱癌患者被随机分配到TURB（n=43）或TURB加BCG（n=43）。两组之间进展的不良肿瘤特征分布均匀。BCG每周给药一次，共6周。此后每3至6个月评估患者是否进展为肌肉浸润或转移。对照组（TURB）浅表肿瘤复发的患者有资格交叉至BCG组。所有患者均接受监测，直至事件发生或至少10年（范围，10至14）。结果：10年无进展率为61.9%（95%置信区间[CI]，47.2%-76.7%），对照组为37%（95% CI，22.9%-53.1%）。BCG组未达到中位无进展间隔，对照组为46个月（P= 0.0063）。在18名交叉使用卡介苗的对照患者中（中位数，29个月），15名患者没有显示肿瘤进展，经尿道膀胱切除术加卡介苗的10年疾病特异性生存率为75%，而单独经尿道膀胱切除术的10年疾病特异性生存率为55%（P= 0.03）。结论：这项研究表明，膀胱内治疗可以延缓浅表性膀胱癌患者的肿瘤进展和肿瘤死亡。(C)1995年，美国临床肿瘤学会。
Purpose: Superficial bladder rumors (stage Ta, T1, and Tis) may progress to invade the bladder muscle and cause death from metastatic cancer. Transurethral tumor resection (TURB) is the standard therapy for such tumors, but surgery alone may not prevent tumor progression. Intravesical therapy is widely used as an adjunct to TURB. Bacillus Calmette-Guerin (BCG) is the most active intravesical agent, but whether BCG prevents tumor progression and death from bladder cancer is unknown.Patients and Methods: Between 1978 and 1981, 86 high-risk patients with superficial bladder cancer were randomly assigned to receive either TURB (n=43) or TURB plus BCG (n=43). Adverse tumor features for progression were equally distributed between the two groups. BCG was administered weekly for 6 weeks. Patients were evaluated every 3 to 6 months thereafter for progression to muscle invasion or metastasis. Control (TURB) patients with recurrent superficial tumors were eligible for crossover to the BCG arm. All patients have been monitored until event or for a minimum of 10 years (range, 10 to 14).Results: The 10-year progression-free rate was 61.9% (95% confidence interval [Cl], 47.2% to 76.7%) for patients treated with BCG and 37% (95% CI, 22.9% to 53.1%) for control patients. The median progression-free interval was not reached for the BCG group and was 46 months for the control group (P=.0063). Of 18 control patients crossed over to BCG (median, 29 months), 15 did not show tumor progression, TURB plus BCG resulted in a 10-year disease-specific survival rate of 75%, compared with 55% with TURB alone (P=.03).Conclusion: This study shows that intravesical therapy with delays tumor progression and death from tumor in patients who present with superficial bladder cancer. (C) 1995 by American Society of Clinical Oncology.