4月19日，新英格兰杂志（New England Journal of Medicine）发表的一项研究结果显示，将化疗添加到标准剂量放疗中可提高膀胱癌的存活率。
肌肉浸润性膀胱癌通常使用手术治疗，但是放疗提供了切除术外的另一种选择。本试验结果显示联合化疗和放疗可产生更好的结果，可能是时候重新评估保留膀胱和手术在治疗肌肉浸润性膀胱癌中的作用了，尤其是针对那些具有手术并发症高风险的病人。
研究组由Nicholas James领导，研究结果显示放化疗可显著改善膀胱癌的局部控制。化疗的添加可减少33%的局部复发的风险，减少近50%的侵袭性复发风险。
William U. Shipley教授和Anthony L. Zietman教授在同期述评中写到，该项具有里程碑式的研究具有改变临床实践的结果。他们指出，该研究在放疗基础上加上了可耐受的化疗方案，比单独放疗治愈明显更多的病人，治疗速度与最好的膀胱切除术类似。
这个氟尿嘧啶和丝裂霉素C的方案是否应该被顺铂为基础的联合方案所替代尚未可知。评论者写到，我们怀疑，在出现对这两种方案直接进行对比的研究之前，化疗药物的选择取决于医生。可能倾向于在老年人中使用氟尿嘧啶和丝裂霉素C方案，在较年轻患者中使用顺铂，为了更好的肾功能和整体健康。
最终，做出放化疗的决定以及选择何种化疗药物，将通过对肿瘤组织的治疗前分子分析来决定。
研究细节
在这项研究中，2001~2008年来自43个中心的360名患者被随机分配到放化疗组（n=182）和放疗组（n=178）。此外，另外有219名参与者被随机接受全膀胱或修改剂量的放疗。共有121名患者经历两种比较。
放化疗组与单独放疗相比，前者的局部无病生存期显著提高，两者的两年无复发率分别为67%和54%。放化疗可导致膀胱全切的减少，放化疗组的两年发生率为11.4%，放疗组为16.8%（P=0.07）。
总体而言，共有208名死亡（放化疗组为98，放疗组为110）。放化疗组的5年总体生存率为48%，放疗组为35%。（生物谷Bioon.com）
doi:N Engl J Med 2012; 366:1477-1488
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Radiotherapy with or without Chemotherapy in Muscle-Invasive Bladder Cancer
Nicholas D. James, M.B., B.S., Ph.D., Syed A. Hussain, M.B., B.S., M.D., Emma Hall, Ph.D., Peter Jenkins, M.B., B.S., Ph.D., Jean Tremlett, M.Sc., Christine Rawlings, M.Sc., Malcolm Crundwell, M.D., B.Chir., Bruce Sizer, M.B., B.S., Thiagarajan Sreenivasan, M.B., B.S., Carey Hendron, M.Sc., Rebecca Lewis, B.Sc., Rachel Waters, M.Sc., and Robert A. Huddart, M.B., B.S., Ph.D. for the BC2001 Investigators
Background
Radiotherapy is an alternative to cystectomy in patients with muscle-invasive bladder cancer. In other disease sites, synchronous chemoradiotherapy has been associated with increased local control and improved survival, as compared with radiotherapy alone.
Methods
In this multicenter, phase 3 trial, we randomly assigned 360 patients with muscle-invasive bladder cancer to undergo radiotherapy with or without synchronous chemotherapy. The regimen consisted of fluorouracil (500 mg per square meter of body-surface area per day) during fractions 1 to 5 and 16 to 20 of radiotherapy and mitomycin C (12 mg per square meter) on day 1. Patients were also randomly assigned to undergo either whole-bladder radiotherapy or modified-volume radiotherapy (in which the volume of bladder receiving full-dose radiotherapy was reduced) in a partial 2-by-2 factorial design (results not reported here). The primary end point was survival free of locoregional disease. Secondary end points included overall survival and toxic effects.
Results
At 2 years, rates of locoregional disease–free survival were 67% (95% confidence interval [CI], 59 to 74) in the chemoradiotherapy group and 54% (95% CI, 46 to 62) in the radiotherapy group. With a median follow-up of 69.9 months, the hazard ratio in the chemoradiotherapy group was 0.68 (95% CI, 0.48 to 0.96; P=0.03). Five-year rates of overall survival were 48% (95% CI, 40 to 55) in the chemoradiotherapy group and 35% (95% CI, 28 to 43) in the radiotherapy group (hazard ratio, 0.82; 95% CI, 0.63 to 1.09; P=0.16). Grade 3 or 4 adverse events were slightly more common in the chemoradiotherapy group than in the radiotherapy group during treatment (36.0% vs. 27.5%, P=0.07) but not during follow-up (8.3% vs. 15.7%, P=0.07).
Conclusions
Synchronous chemotherapy with fluorouracil and mitomycin C combined with radiotherapy significantly improved locoregional control of bladder cancer, as compared with radiotherapy alone, with no significant increase in adverse events. (Funded by Cancer Research U.K.; BC2001 Current Controlled Trials number, ISRCTN68324339.)
