El-Ghobashy Samir, El-Leithy Tarek R, Roshdy Mamdouh M, El-Ganzoury Hossam M
The Department of Urology, Theodor Bilharz Research Institute, Cairo.
J Egypt Natl Canc Inst. 2007 Jun;19(2):121-6.
We analyzed the impact of a single Mitomycin C instillation in patients with low risk superficial bladder cancer with short and long-term follow-up.
This study was conducted on 63 patients with low risk superficial bladder transitional cell carcinoma (TCC), admitted to the Urology Department, Theodor Bilharz Research Institute (TBRI) during the period from January 2002 to August 2005. All patients had a 2 cm. or less single, papillary, primary or recurrent tumor and were disease-free for more than 1 year. Patients with muscular invasion, G III tumor or bladder carcinoma in situ on pathological examination were excluded from the study. The tumor was completely resected before patients were divided randomly into 2 arms: first group who have received no further treatment (control group) and a second group with a single immediate instillation of 30 mg. Mitomycin C (mitomycin C group). Recurrences were considered early if they occurred within the first 2 years of follow-up.
At 24-months follow-up, the recurrence-free interval was significantly increased and recurrence, recurrence per year and tumor per year rates were decreased in the mitomycin C group compared to the control group. Early recurrence was (16.1%) in the mitomycin C group versus (34.3%) in the control group. It was noted also that early recurrences were concentrated in the first year in the control group (18.7%) versus (3.2%) in the mitomycin C group. However, at long-term follow-up, these differences were not statistically significant (26.9%) in the mitomycin C group versus (28.6%) in the control group, and the recurrence-free interval curves were parallel. A significant relationship between early and late recurrences was found in the mitomycin C, but not in the control group. Shorter hospital stay and catheterization periods were noted in the mitomycin C group compared to the control group, but the differences were not statistically significant.
These data confirm 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 follow-up. Thus, this approach is an alternative to observation or classic long-term intravesical chemotherapy. Our study also suggests that cell implantation as a mechanism of early recurrence can be controlled or minimized with a single mitomycin C instillation.
我们分析了单次丝裂霉素C膀胱灌注对低危浅表性膀胱癌患者的影响，并进行了短期和长期随访。
本研究对2002年1月至2005年8月期间入住 Theodor Bilharz 研究所（TBRI）泌尿外科的63例低危浅表性膀胱移行细胞癌（TCC）患者进行。所有患者均有一个直径2 cm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。病理检查有肌层浸润、G III级肿瘤或原位膀胱癌的患者被排除在研究之外。在患者被随机分为两组之前，肿瘤已被完全切除：第一组未接受进一步治疗（对照组），第二组立即单次灌注30 mg丝裂霉素C（丝裂霉素C组）。如果复发发生在随访的前2年内，则视为早期复发。
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、每年复发率和每年肿瘤发生率均降低。丝裂霉素C组的早期复发率为（16.1%），而对照组为（34.3%）。还注意到，对照组的早期复发集中在第一年（18.7%），而丝裂霉素C组为（3.2%）。然而，在长期随访中，丝裂霉素C组与对照组的这些差异无统计学意义（分别为26.9%和28.6%），无复发生存期曲线平行。在丝裂霉素C组中发现早期和晚期复发之间存在显著关系，但在对照组中未发现。与对照组相比，丝裂霉素C组的住院时间和导尿时间较短，但差异无统计学意义。
这些数据证实了单次立即丝裂霉素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，长期随访后并未维持。因此，这种方法是观察或经典长期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膀胱灌注可以控制或最小化作为早期复发机制的细胞植入。
