Solsona E, Iborra I, Ricós J V, Monrós J L, Casanova J, Dumont R
Department of Urology, Instituto Valenciano de Oncologia, Valencia, Spain.
J Urol. 1999 Apr;161(4):1120-3.
We analyze the impact of a single mitomycin C instillation in patients with low risk superficial bladder cancer with short and long-term followup.
A total of 131 patients with low risk superficial bladder cancer were included in a prospective randomized controlled trial. All patients had a 3 cm or less single, papillary, primary or recurrent tumor and were disease-free for more than 1 year. Patients with muscular invasion, G3 tumor or bladder carcinoma in situ on pathological examination were excluded from study. The tumor was completely resected before patients were randomized into 2 arms of no further treatment (control group) and a single immediate instillation of 30 mg mitomycin C (mitomycin C group). Recurrences were considered early within the first 2 years of followup.
At 24-month followup the recurrence-free interval was significantly increased, and recurrence, and recurrence and tumor per year rates were decreased in the mitomycin C compared to the control group. However, at long-term followup these differences were not statistically significant and the recurrence-free interval curves were parallel. A shorter hospital stay and catheterization period were noted in the mitomycin C group compared to the control group, which were not significant. Early recurrences were concentrated in the first year in the control but not in the mitomycin C group. A significant relationship between early and late recurrences was found in the mitomycin C but not in the control group.
Our analysis confirms the positive effect of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer. This benefit is limited to early recurrence and is not maintained with long-term followup. Thus, this approach is an alternative to observation or endovesical chemotherapy. Our study also suggests that cell implantation as a mechanism of early recurrence can be controlled with a single mitomycin C instillation.
我们分析单次丝裂霉素C膀胱灌注对低危浅表性膀胱癌患者的影响,并进行短期和长期随访。
131例低危浅表性膀胱癌患者纳入一项前瞻性随机对照试验。所有患者均有一个直径3cm或更小的单发、乳头状、原发性或复发性肿瘤,且无病生存期超过1年。病理检查发现有肌层浸润、G3肿瘤或原位膀胱癌的患者被排除在研究之外。在患者被随机分为不再进一步治疗组(对照组)和单次即刻灌注30mg丝裂霉素C组(丝裂霉素C组)之前,肿瘤已被完全切除。复发被视为随访的前2年内的早期复发。
在24个月的随访中,与对照组相比,丝裂霉素C组的无复发生存期显著延长,复发率以及每年的复发和肿瘤发生率均降低。然而,在长期随访中,这些差异无统计学意义,无复发生存期曲线平行。与对照组相比,丝裂霉素C组的住院时间和导尿时间较短,但差异不显著。对照组的早期复发集中在第一年,而丝裂霉素C组则不然。在丝裂霉素C组中发现早期和晚期复发之间存在显著相关性,而对照组中则未发现。
我们的分析证实了单次即刻丝裂霉素C膀胱灌注对低危浅表性膀胱癌患者的积极作用。这种益处仅限于早期复发,长期随访后不能维持。因此,这种方法是观察或膀胱内化疗的一种替代方法。我们的研究还表明,单次丝裂霉素C灌注可以控制作为早期复发机制的细胞植入。