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术后与术前辅助放疗治疗肌层浸润性膀胱癌的前瞻性随机试验。

A prospective randomized trial for postoperative vs. preoperative adjuvant radiotherapy for muscle-invasive bladder cancer.

机构信息

Department of Radiation, National Cancer Institute, Cairo University, Cairo, Egypt.

出版信息

Urol Oncol. 2013 Apr;31(3):359-65. doi: 10.1016/j.urolonc.2011.01.008. Epub 2011 Feb 25.

DOI:10.1016/j.urolonc.2011.01.008
PMID:21353794
Abstract

PURPOSE

Although radical cystectomy is considered to be the primary treatment for muscle-invasive bladder cancer, it is associated with unfavorable outcome. Local recurrence is still a major problem. Survival rates as well as quality of live are far from being satisfactory. Postoperative radiotherapy is considered the standard adjuvant treatment in the NCI-Egypt. This is a prospective randomized study conducted to compare preoperative with postoperative radiotherapy as regard the survival and complication rates.

PATIENTS AND METHODS

In the period from May, 2004 to June 2007, 100 eligible patients were included into the study, 50 patients in each treatment arm. Pelvic irradiation was identical in both groups aiming at 50 Gy/25 Fs/5 wk. Radical cystectomy was the standard surgery. Locoregional control, survival rates, and complications rates were compared in both arms.

RESULTS

Patients had a median follow-up period of 32 months (range 0-69 months). Patients had an average age of 54.8 ± 9.5 years with a male/female ratio 3:1. In the present study, transitional cell carcinoma constitutes (51%), while squamous cell carcinoma was reported in 46% of cases. Grades II and III pathology were 81% and 17%, respectively. Pathological stage P2b was encountered in 39.5% of the patients followed by P3b (33.3%) and P3a (14.6%). For the preoperative group, the 3-year overall survival, disease-free survival, locoregional control, and metastases-free survival rates were 53.4%, 47.4%, 89.3%, and 61.5%, respectively. The corresponding figures for the postoperative group were 51.8%, 34.1%, 80.6%, and 55.7% for the postoperative group. None of the patients had serious radiation reactions.

CONCLUSION

In our study, preoperative radiotherapy was almost equivalent to postoperative radiation therapy as regard OS, DFS, as well as complication rates. Given the recent physical developments in radiation therapy techniques and the biological rationale for treating the pelvis after cystectomy, adjuvant radiotherapy should be re-evaluated world wide. Preoperative radiotherapy may re-emerge as a useful tool for adjuvant treatment.

摘要

目的

尽管根治性膀胱切除术被认为是肌层浸润性膀胱癌的主要治疗方法,但它与不良预后相关。局部复发仍然是一个主要问题。生存率和生活质量远未令人满意。术后放疗被认为是 NCI-Egypt 的标准辅助治疗。这是一项前瞻性随机研究,旨在比较术前和术后放疗在生存率和并发症发生率方面的差异。

方法

在 2004 年 5 月至 2007 年 6 月期间,共有 100 名符合条件的患者被纳入研究,每组 50 例。两组患者均接受相同的盆腔放疗,总剂量为 50 Gy/25 次/5 周。根治性膀胱切除术是标准手术。比较两组患者的局部区域控制率、生存率和并发症发生率。

结果

患者的中位随访时间为 32 个月(范围 0-69 个月)。患者的平均年龄为 54.8±9.5 岁,男女比例为 3:1。在本研究中,移行细胞癌占 51%,而鳞状细胞癌占 46%。病理分级 II 级和 III 级分别为 81%和 17%。病理分期 P2b 占 39.5%,其次是 P3b(33.3%)和 P3a(14.6%)。对于术前组,3 年总生存率、无病生存率、局部区域控制率和无转移生存率分别为 53.4%、47.4%、89.3%和 61.5%。术后组的相应数据分别为 51.8%、34.1%、80.6%和 55.7%。没有患者出现严重的放射反应。

结论

在我们的研究中,术前放疗在 OS、DFS 以及并发症发生率方面与术后放疗几乎相当。鉴于最近放射治疗技术的物理发展和膀胱癌根治术后盆腔治疗的生物学原理,辅助放疗应该在全球范围内重新评估。术前放疗可能重新成为辅助治疗的有用工具。

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