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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma.
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Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma.

机译:一项前瞻性随机试验的结果,将常规放疗与鼻咽癌分期分次放疗进行了比较。

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BACKGROUND AND PURPOSE: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. PATIENTS AND METHODS: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2Gy/fraction/day, 5 days/week to 70Gy/7 weeks or split course bifractionated radiotherapy at 1.6Gy/fraction, twice daily, 5 days/week to 70.4Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. RESULTS: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p=0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p=0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p=0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. COMMENTS: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin fibrosis.
机译:背景与目的:鼻咽癌(NPC)通常对放射治疗有反应。然而,常规放疗后的治疗效果仍然相对较差,特别是对于局部晚期NPC患者。这项研究的目的是在一项III期随机试验中评估分期分次放疗方案的影响。患者与方法:从1997年1月至2003年9月,我们机构接受了154例经组织学证实为M0的NPC患者的治疗。它们是根据美国癌症联合委员会-国际抗癌联盟(AJCC-UICC)1986 TNM分类进行的。患有局部晚期淋巴结病(N2-N3)的患者接受了诱导化疗。所有患者被随机分配接受常规放疗,剂量为2Gy /次/天,每天5天/周至70Gy / 7周,或分次分次放疗,剂量为1.6Gy /次,每日两次,每日5天/周至70.4Gy / 6周。根据WHO和RTOG标准评估反应和毒性。结果:两组患者之间平衡良好。常规放疗组的完全缓解率为91%,双分割放疗组的完全缓解率为93%(p = 0.3)。实验组中II-III级皮肤纤维化的发生率更高,五年期精算几率分别为66%和52%(p = 0.04)。在常规组中有34%的病例发生局部和远处复发,在实验组中有38%发生局部复发(p = 0.28)。中位随访56个月,常规组的5年总生存率和无病生存率分别为71%和61%,而双歧组的无病生存率分别为62%和60%。在统计上不显着。评论:本试验将常规放疗与分次疗程双分割放疗进行了比较,未能证明实验组的局部控制和存活率显着改善,这与更多的II-III级皮肤纤维化有关。

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