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韩国原发性 T1G3 膀胱癌的辅助膀胱内灌注:BCG 与 MMC 的比较。

Adjuvant intravesical instillation for primary T1G3 bladder cancer: BCG versus MMC in Korea.

机构信息

Department of Urology, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.

出版信息

Anticancer Res. 2012 Apr;32(4):1493-8.

Abstract

AIM

To compare the efficacy of bacillus Calmette-Guerin (BCG) and mitomycin-C (MMC) intravesical instillation for primary T1G3 bladder cancer (BC).

PATIENTS AND METHODS

This retrospective study included 107 patients with newly diagnosed primary T1G3 BC who were treated by transurethral resection (TUR) plus intravesical instillation. The BCG group was administered BCG-RIVM (2×10(8) colony forming unit) instilled once weekly for 6 weeks, or the same regimen as induction therapy followed by three once-weekly instillations at 3, 6, 12 and 18 months after initiation of the induction therapy. The MMC group was administered MMC (30 mg) in six weekly instillations, or the same regimen with subsequent monthly instillations for one year. We evaluated differences between these agents in disease recurrence-free survival and disease progression rate at the time of recurrence.

RESULTS

The mean observation period was 24.3±28.6 months. The BCG and MMC groups comprised 53 patients (49.5%) and 54 patients (50.5%), respectively. During the observation period, recurrences developed in 61 patients (57.0%). The median time to recurrence for the BCG and MMC arm were 24.0 and 26.0 months, respectively. There were no significant differences for recurrence-free survival between the two groups (log-rank p=0.616). At the time of recurrence, 9.4% (5 out of 53) of patients in the BCG arm and 7.4% (4 out of 54) patients in the MMC arm also experienced by disease progression (p=1.000).

CONCLUSION

There were no statistically significant differences regarding recurrence and disease progression rate at the time of recurrence between the two adjuvant treatments in primary T1G3 BC. Thus, large prospective studies in Asian population are required.

摘要

目的

比较卡介苗(BCG)和丝裂霉素 C(MMC)膀胱内灌注治疗原发性 T1G3 膀胱癌(BC)的疗效。

患者和方法

本回顾性研究纳入了 107 例新诊断的原发性 T1G3 BC 患者,均接受经尿道切除术(TUR)联合膀胱内灌注治疗。BCG 组采用卡介苗-RIVM(2×10(8)集落形成单位)每周一次灌注,共 6 周;或相同方案诱导治疗后,在诱导治疗开始后 3、6、12 和 18 个月时各进行一次每周一次的灌注。MMC 组采用丝裂霉素 C(30mg)每周六次灌注;或相同方案诱导治疗后,在 1 年内每月进行一次灌注。我们评估了这两种药物在疾病无复发生存率和复发时疾病进展率方面的差异。

结果

平均观察期为 24.3±28.6 个月。BCG 组和 MMC 组分别有 53 例(49.5%)和 54 例(50.5%)患者。在观察期间,61 例(57.0%)患者复发。BCG 和 MMC 组的中位复发时间分别为 24.0 和 26.0 个月。两组无复发生存率无显著差异(对数秩检验,p=0.616)。在复发时,BCG 组 9.4%(5 例)和 MMC 组 7.4%(4 例)的患者疾病也出现进展(p=1.000)。

结论

在原发性 T1G3 BC 中,两种辅助治疗方法在复发和复发时疾病进展率方面无统计学差异。因此,需要在亚洲人群中进行大规模的前瞻性研究。

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