Pawinski A, Sylvester R, Kurth K H, Bouffioux C, van der Meijden A, Parmar M K, Bijnens L
Department of Urology, Memorial Cancer Center, Warsaw, Poland.
J Urol. 1996 Dec;156(6):1934-40, discussion 1940-1.
The use of prophylactic agents after primary resection can decrease the incidence of tumor recurrence in patients with stage TaT1 bladder cancer. However, the long-term impact on progression to muscle invasive disease as well as on duration of survival is unknown. A combined analysis of individual patient data from previously performed European Organization for Research and Treatment of Cancer (EORTC) and Medical Research Council (MRC) randomized clinical trials was done in an attempt to answer these crucial questions. We compared immediate versus no adjuvant prophylactic treatment after transurethral resection with respect to disease-free interval, time to progression to muscle invasive disease, time to appearance of distant metastases, duration of survival and progression-free survival.
All EORTC and MRC prophylactic, randomized phase III trials with primary or recurrent, stage TaT1 transitional cell bladder cancer that compared transurethral resection alone or with adjuvant prophylactic treatment were included in the study. Four EORTC and 2 MRC trials using intravesical chemotherapy or oral agents and including a total of 2,535 patients were studied.
A statistically significant effect of adjuvant treatment over no adjuvant treatment was found in terms of the duration of the disease-free interval (p < 0.01). No clear advantage of adjuvant treatment was shown with respect to progression to invasive disease, time to appearance of distant metastases or duration of survival and progression-free survival. Median survival followup was 7.8 years.
Despite prologation of the disease-free-interval adjuvant treatment has no apparent long-term impact on the evolution of stage TaTi bladder cancer.
对于TaT1期膀胱癌患者，在初次切除术后使用预防药物可降低肿瘤复发率。然而，其对进展为肌层浸润性疾病以及生存时间的长期影响尚不清楚。我们对先前开展的欧洲癌症研究与治疗组织（EORTC）和医学研究理事会（MRC）随机临床试验中的个体患者数据进行了综合分析，试图回答这些关键问题。我们比较了经尿道切除术后立即进行辅助预防性治疗与不进行辅助预防性治疗在无病间期、进展为肌层浸润性疾病的时间、远处转移出现的时间、生存时间和无进展生存时间方面的差异。
本研究纳入了所有EORTC和MRC开展的预防性、随机III期试验，这些试验针对原发性或复发性TaT1期移行细胞膀胱癌，比较了单纯经尿道切除术或联合辅助预防性治疗。研究了4项EORTC试验和2项MRC试验，这些试验使用膀胱内化疗或口服药物，共纳入2535例患者。
在无病间期的持续时间方面，辅助治疗对比无辅助治疗有统计学显著效果（p < 0.01）。在进展为浸润性疾病、远处转移出现的时间、生存时间和无进展生存时间方面，未显示辅助治疗有明显优势。中位生存随访时间为7.8年。
尽管辅助治疗延长了无病间期，但对TaT1期膀胱癌的进展并无明显长期影响。
