4月19日,，新英格蘭雜志（New England Journal of Medicine）發(fā)表的一項(xiàng)研究結(jié)果顯示,，將化療添加到標(biāo)準(zhǔn)劑量放療中可提高膀胱癌的存活率。
肌肉浸潤(rùn)性膀胱癌通常使用手術(shù)治療,，但是放療提供了切除術(shù)外的另一種選擇,。本試驗(yàn)結(jié)果顯示聯(lián)合化療和放療可產(chǎn)生更好的結(jié)果，可能是時(shí)候重新評(píng)估保留膀胱和手術(shù)在治療肌肉浸潤(rùn)性膀胱癌中的作用了,，尤其是針對(duì)那些具有手術(shù)并發(fā)癥高風(fēng)險(xiǎn)的病人,。
研究組由Nicholas James領(lǐng)導(dǎo)，研究結(jié)果顯示放化療可顯著改善膀胱癌的局部控制,?；煹奶砑涌蓽p少33%的局部復(fù)發(fā)的風(fēng)險(xiǎn)，減少近50%的侵襲性復(fù)發(fā)風(fēng)險(xiǎn),。
William U. Shipley教授和Anthony L. Zietman教授在同期述評(píng)中寫(xiě)到,，該項(xiàng)具有里程碑式的研究具有改變臨床實(shí)踐的結(jié)果。他們指出,，該研究在放療基礎(chǔ)上加上了可耐受的化療方案,，比單獨(dú)放療治愈明顯更多的病人，治療速度與最好的膀胱切除術(shù)類(lèi)似,。
這個(gè)氟尿嘧啶和絲裂霉素C的方案是否應(yīng)該被順鉑為基礎(chǔ)的聯(lián)合方案所替代尚未可知,。評(píng)論者寫(xiě)到，我們懷疑,，在出現(xiàn)對(duì)這兩種方案直接進(jìn)行對(duì)比的研究之前,，化療藥物的選擇取決于醫(yī)生,。可能傾向于在老年人中使用氟尿嘧啶和絲裂霉素C方案,，在較年輕患者中使用順鉑,，為了更好的腎功能和整體健康。
最終,，做出放化療的決定以及選擇何種化療藥物,，將通過(guò)對(duì)腫瘤組織的治療前分子分析來(lái)決定。
研究細(xì)節(jié)
在這項(xiàng)研究中,，2001~2008年來(lái)自43個(gè)中心的360名患者被隨機(jī)分配到放化療組（n=182）和放療組（n=178）,。此外，另外有219名參與者被隨機(jī)接受全膀胱或修改劑量的放療,。共有121名患者經(jīng)歷兩種比較,。
放化療組與單獨(dú)放療相比，前者的局部無(wú)病生存期顯著提高,，兩者的兩年無(wú)復(fù)發(fā)率分別為67%和54%,。放化療可導(dǎo)致膀胱全切的減少，放化療組的兩年發(fā)生率為11.4%,，放療組為16.8%（P=0.07）,。
總體而言，共有208名死亡（放化療組為98,，放療組為110）,。放化療組的5年總體生存率為48%，放療組為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.)
