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膀胱T1期肿瘤患者接受膀胱内丝裂霉素治疗后重复经尿道切除术对复发率和进展率的影响:一项前瞻性随机临床试验。

The effect of repeat transurethral resection on recurrence and progression rates in patients with T1 tumors of the bladder who received intravesical mitomycin: a prospective, randomized clinical trial.

作者信息

Divrik Rauf Taner, Yildirim Umit, Zorlu Ferruh, Ozen Haluk

机构信息

Department of Urology, SB Tepecik Research and Teaching Hospital, Izmir, Turkey.

出版信息

J Urol. 2006 May;175(5):1641-4. doi: 10.1016/S0022-5347(05)01002-5.

Abstract

PURPOSE

We compared the outcomes of repeat transurethral resection plus intravesical mitomycin C with initial transurethral resection of bladder plus intravesical MMC in patients with newly diagnosed pT1 transitional cell carcinoma of the bladder in terms of recurrence, progression and overall survival.

MATERIALS AND METHODS

Of 148 newly diagnosed patients with T1 bladder cancer 142 were prospectively randomized in 2 groups between January 2001 and January 2005. A total of 74 patients underwent second TURB and received adjuvant MMC intravesically (group 1) and 68 patients received adjuvant MMC following the initial TURB (group 2). All repeat TURB operations were performed 2 to 6 weeks following initial TURB. Patients with incomplete resection, Cis or muscle invasive disease were excluded from study. The first dose of mitomycin C (40 mg per week for a total of 8 weeks) was instilled intravesically in all patients during the first 24 hours after the last surgery.

RESULTS

Mean followup was 31.5 months (range 6 to 48) with no difference between the 2 groups. The rate of recurrence-free survival was 86.35% (SE 0.4%), 77.67% and 68.72% in group 1, and 47.08%, 42.31% and 37.01% in group 2 for the first, second and third year, respectively (overall 74.32% vs 36.76%, log rank 0.0001). Recurrence was observed in 19 of the 74 (25.68%) patients in group 1 and in 43 of the 68 (63.24%) patients in group 2. Ten of the 19 (52.63%) patients in group 1 and 35 of the 43 (81.39%) patients in group 2 had recurrence within 12 months. Recurrence was observed in 17.6%, 25% and 60% of patients with G1, G2 and G3 tumors, respectively, in group 1. The same rates for group 2 were 25%, 64% and 90%. The RFS rate was significantly worse in the high grade group (G2 and G3) (p <0.001). Progression was observed at 4.05% for group 1 compared to 11.76% for group 2 (log rank 0.0974). OS was 91.89% and 89.71% in group 1 and 2, respectively (log rank 0.732).

CONCLUSIONS

The high recurrence rate in patients who did not undergo ReTUR is due to a high residual tumor rate following initial TURB. The benefit of ReTUR is especially true for high grade tumors. Since intravesical MMC was present in both groups, this study has shown that intravesical chemotherapy does not compensate for inadequate resection. Progression does not seem to be affected by ReTUR although there was a trend favoring the ReTUR group. We recommend ReTUR for patients with primary high grade T1 disease to achieve better recurrence-free survival.

摘要

目的

我们比较了初次经尿道膀胱肿瘤切除术加膀胱内灌注丝裂霉素C与重复经尿道膀胱肿瘤切除术加膀胱内灌注丝裂霉素C对新诊断的膀胱pT1期移行细胞癌患者复发、进展及总生存的影响。

材料与方法

2001年1月至2005年1月,148例新诊断的T1期膀胱癌患者中,142例被前瞻性随机分为两组。74例患者接受二次经尿道膀胱肿瘤切除术并膀胱内给予辅助性丝裂霉素C(第1组),68例患者在初次经尿道膀胱肿瘤切除术后接受辅助性丝裂霉素C(第2组)。所有重复经尿道膀胱肿瘤切除术均在初次经尿道膀胱肿瘤切除术后2至6周进行。切除不完全、Cis或肌层浸润性疾病患者被排除在研究之外。所有患者在最后一次手术后的头24小时内膀胱内灌注第一剂丝裂霉素C(每周40mg,共8周)。

结果

平均随访31.5个月(6至48个月),两组间无差异。第1组第1年、第2年和第3年无复发生存率分别为86.35%(标准误0.4%)、77.67%和68.72%,第2组分别为47.08%、42.31%和37.01%(总体74.32%对36.76%,对数秩检验P=0.0001)。第1组74例患者中有19例(25.68%)复发,第2组68例患者中有43例(63.24%)复发。第1组19例患者中有10例(52.63%)在12个月内复发,第2组43例患者中有35例(81.39%)在12个月内复发。第1组G1、G2和G3肿瘤患者的复发率分别为17.6%、25%和60%。第2组的相同复发率分别为25%、64%和90%。高级别组(G2和G3)的无复发生存率明显更差(P<0.001)。第1组进展率为4.05%,第2组为11.76%(对数秩检验P=0.(0974)。第组和第2组的总生存率分别为91.89%和89.71%(对数秩检验P=0.732)。

结论

未接受重复经尿道膀胱肿瘤切除术患者的高复发率是由于初次经尿道膀胱肿瘤切除术后残留肿瘤率高。重复经尿道膀胱肿瘤切除术的益处对于高级别肿瘤尤其明显。由于两组均采用膀胱内丝裂霉素C,本研究表明膀胱内化疗不能弥补切除不充分的问题。尽管有倾向于重复经尿道膀胱肿瘤切除术组的趋势,但进展似乎不受重复经尿道膀胱肿瘤切除术的影响。我们建议对原发性高级别T1期疾病患者进行重复经尿道膀胱肿瘤切除术以获得更好的无复发生存率。

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