背景:局部晚期膀胱癌根治性膀胱切除术后的辅助放疗在精确放疗的进展后恢复,降低了正常盆腔组织的放射危害。然而,解决这一问题的随机对照研究仍然很少。
方法:纳入了131例膀胱切除术后的尿路上皮膀胱癌患者;122例随机接受辅助放疗(ART)50Gy/25分,膀胱切除术或单纯膀胱切除术(CY)后4周。在ART组中包括62个,在CY组中包括60个。24例ART和30例CY患者接受了新辅助化疗。11例患者(9%)有共同的新膀胱改道,6在艺术中,和5在CY武器。所有ART患者均接受调强放疗(IMRT),每日验证锥形束CT(CBCT)。中位随访时间为42.7个月。
结果:ART组的3年调整局部区域无复发生存率(LRFS)较高,测量81%(95CI:69-94),而71%(95%CI:60-80)(p=0.0457)。ART显着提高了膀胱切除术床和骨盆侧壁的局部无复发率(分别为p=0.016和0.001)。总生存率,无事件,无远处转移生存率在2组中没有达到统计学意义的水平。尽管ART的急性副作用略高,两组的晚期毒性几乎相等.
结论:在根治性膀胱切除术后使用精确放射技术时,辅助放疗是安全且相当耐受的。这些技术显着改善了LRFS,但对总体生存率的改善不明显。ART不影响无远处转移生存率。在世界各地的不同中心进行了类似的研究,以证实ART在尿路上皮膀胱癌中的价值。
OBJECTIVE: Adjuvant radiation therapy (ART) after radical cystectomy in locally advanced bladder cancer was revived after the advancement in precise radiation therapy that decreased the normal pelvic tissue radiation hazards. However, there are still scarce controlled randomized studies addressing this issue.
METHODS: One hundred thirty-one cystectomized urothelial bladder cancer patients were enrolled; 122 were randomized to receive ART of 50 Gy/25 fractions 4 weeks after cystectomy or cystectomy alone (CY). Sixty-two were included in the ART arm and 60 in the CY arm. Twenty-four ART and 30 CY patients received neoadjuvant chemotherapy. Eleven patients (9%) had cotenant neobladder diversion, 6 in ART, and 5 in CY arms. All ART patients were treated with intensity modulated radiation therapy with daily verification cone beam computed tomography. The median follow-up was 42.7 months.
RESULTS: The 3-year adjusted locoregional recurrence-free survival rate was higher in the ART arm, measuring 81% (95% CI, 69%-94%) compared with 71% (95% CI, 60%-80%; p = .0457). ART significantly improved the locoregional relapse-free rate in the cystectomy bed and the pelvic side wall (p = .016 and p = .001, respectively). The overall, event-free, and distant metastasis-free survival did not rank to the level of statistical significance in the 2 arms. Even though the acute side effects were slightly higher in ART, the late toxicities were almost equal in the 2 groups.
CONCLUSIONS: ART is safe and quite tolerable after radical cystectomy when using precise radiation techniques. These techniques significantly improved the locoregional recurrence-free survival but had insignificant improvement on the overall survival. ART did not affect the distant metastasis-free survival. Similar studies are performed in different centers around the world to confirm the value of ART in urothelial bladder cancer.