Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck.

Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck.
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DOI:
10.1016/j.ijrobp.2012.05.008
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发表时间:
2012-12-01
影响因子:
7
通讯作者:
Ang, K. Kian
Ang, K. Kian
中科院分区:
医学1区
文献类型:
--
作者:
Cooper, Jay S.;Zhang, Qiang;Pajak, Thomas F.;Forastiere, Arlene A.;Jacobs, John;Saxman, Scott B.;Kish, Julie A.;Kim, Harold E.;Cmelak, Anthony J.;Rotman, Marvin;Lustig, Robert;Ensley, John F.;Thorstad, Wade;Schultz, Christopher J.;Yom, Sue S.;Ang, K. Kian

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先前对这项组间试验的分析表明,存活患者的中位随访时间为45.9个月,术后同时给予顺铂和放射治疗可改善高危可切除头颈部癌患者的局部区域控制和无病生存。所有患者现在可能至少有10年的随访,本文更新了这些结果,以检查长期结局。410例可分析的高风险切除头颈癌患者前瞻性随机接受放疗(RT:6周内60戈伊)或相同的RT+顺铂,100 mg/m2静脉注射,第1、22和43天(RT + CT)。在10年时,接受RT与RT + CT治疗的患者的局部区域失败率分别为28.8%与22.3%(p=0.10),无病生存率分别为19.1%与20.1%(p=0.25),总生存率分别为27.0%与29.1%(p=0.31)。在仅限于显微镜下累及切除边缘和/或疾病囊外扩散的患者的计划外亚组分析中,局部区域失败发生率分别为33.1%和21.0%(p=0.02),无病生存率分别为12.3%和18.4%(p=0.05),总生存率分别为19.6%和27.1%(p=0.07)。存活患者的中位随访时间为9.4年,在所有随机化合格患者的分析中未观察到结局的显著差异。然而,对显微镜下累及切除边缘和/或疾病囊外扩散的患者亚组的分析显示,同时给予化疗可改善局部区域控制和无病生存。仅因2个或更多淋巴结中有肿瘤而入组的其余患者亚组未从CT加RT中获益。
Previous analysis of this Intergroup trial demonstrated that with a median follow-up among surviving patients of 45.9 months, the concurrent postoperative administration of cisplatin and radiation therapy improved local-regional control and disease-free survival of patients who had high-risk resectable head and neck carcinomas. With a minimum of 10 years of follow-up potentially now available for all patients, these results are herein updated to examine long-term outcomes. 410 analyzable patients who had high-risk resected head and neck cancers were prospectively randomized to receive either radiation therapy (RT: 60 Gy in 6 weeks) or identical RT plus cisplatin, 100 mg/m2 i.v. on days 1, 22, and 43 (RT + CT). At 10 years, the local-regional failure rates were 28.8% vs. 22.3% (p=0.10), disease-free survival was 19.1% vs. 20.1% (p=0.25) and overall survival was 27.0% vs. 29.1% (p=0.31) for patients treated by RT vs. RT + CT respectively. In the unplanned subset analysis limited to patients who had microscopically involved resection margins and/or extracapsular spread of disease, local-regional failure occurred in 33.1% vs. 21.0% (p=0.02), disease-free survival was 12.3% vs. 18.4% (p=0.05) and overall survival was 19.6% vs. 27.1% (p=0.07) respectively. At a median follow-up of 9.4 years for surviving patients no significant differences in outcome were observed in the analysis of all randomized eligible patients. However, analysis of the subgroup of patients who had either microscopically involved resection margins and/or extracapsular spread of disease showed improved local-regional control and disease-free survival with concurrent administration of chemotherapy. The remaining subgroup of patients who were enrolled only because they had tumor in 2 or more lymph nodes did not benefit from the addition of CT to RT.
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发表时间: 1998-06-18
影响因子: 158.5
作者:
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DOI: 10.1056/nejmoa032641
发表时间: 2004-05-06
影响因子: 158.5
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DOI: 10.1016/0021-9681(74)90015-0
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DOI: 10.2307/2281868
发表时间: 1958-01-01
影响因子: 3.7
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DOI: 10.1214/aos/1176350951
发表时间: 1988-09-01
影响因子: 4.5
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GRAY, RJ
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