Malmström P U, Rintala E, Wahlqvist R, Hellström P, Hellsten S, Hannisdal E
Department of Urology, University Hospital Uppsala, Sweden.
J Urol. 1996 Jun;155(6):1903-6.
Chemotherapy is widely used in patients with locally advanced bladder cancer but until now there has been no conclusive evidence that this therapy improves survival. The Nordic Cooperative Bladder Cancer Study Group conducted a randomized phase III study to assess the possible benefit of neoadjuvant chemotherapy in patients with bladder cancer undergoing radical cystectomy after short-term radiotherapy.
Our trial included 325 patients with locally advanced stage T1 grade 3 or stages T2 to T4aNXM0 bladder cancer allocated randomly into a chemotherapy or no chemotherapy group (control). The chemotherapy schedule consisted of 2 cycles of 70 mg./m.2 cisplatin and 30 mg./m.2 doxorubicin with a 3-week interval between the cycles.
After 5 years the overall survival rate was 59% in the chemotherapy group and 51% in the control group (p = 0.1). The corresponding cancer specific survival rate was 64 and 54%, respectively. In regard to treatment, no difference was observed for stages T1 and T2 disease, while there was a 15% difference in overall survival for patients with stages T3 to T4a disease (p = 0.03). In a multivariate analysis only chemotherapy and T category emerged as independent prognostic factors. The relative death risk for patients who received chemotherapy was 0.69 (95% confidence interval 0.49 to 0.98) compared to the control group after adjustment for the other tested factors.
Neoadjuvant chemotherapy seems to improve long-term survival after cystectomy in patients with stages T3 to T4a bladder carcinoma, while no survival benefit was found for stages T1 to T2 disease.
化疗广泛应用于局部晚期膀胱癌患者，但迄今为止尚无确凿证据表明该疗法能提高生存率。北欧膀胱癌症合作研究组开展了一项随机III期研究，以评估新辅助化疗对短期放疗后接受根治性膀胱切除术的膀胱癌患者的潜在益处。
我们的试验纳入了325例局部晚期T1 3级或T2至T4aNXM0期膀胱癌患者，随机分为化疗组或非化疗组（对照组）。化疗方案为每3周1个周期，共2个周期，每次使用顺铂70mg/m²和阿霉素30mg/m²。
5年后，化疗组的总生存率为59%，对照组为51%（p = 0.1）。相应的癌症特异性生存率分别为64%和54%。在治疗方面，T1和T2期疾病未观察到差异，而T3至T4a期疾病患者的总生存率有15%的差异（p = 0.03）。多因素分析显示，只有化疗和T分期是独立的预后因素。在对其他测试因素进行调整后，与对照组相比，接受化疗患者的相对死亡风险为0.69（95%置信区间0.49至0.98）。
新辅助化疗似乎可提高T3至T4a期膀胱癌患者膀胱切除术后的长期生存率，而T1至T2期疾病未发现生存获益。
