ADJUVANT CHEMOTHERAPY FOR RESECTABLE SQUAMOUS-CELL CARCINOMAS OF THE HEAD AND NECK - REPORT ON INTERGROUP STUDY-0034
ADJUVANT CHEMOTHERAPY FOR RESECTABLE SQUAMOUS-CELL CARCINOMAS OF THE HEAD AND NECK - REPORT ON INTERGROUP STUDY-0034
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DOI：
10.1016/0360-3016(92)90642-u
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发表时间：
1992-01-01
影响因子：
7
通讯作者：
CAMPBELL, BH
中科院分区：
文献类型：
--
作者：
LARAMORE, GE;SCOTT, CB;CAMPBELL, BH
为了测试序贯化疗作为手术和术后放疗辅助治疗局部晚期但可手术的头颈部鳞状细胞癌患者的疗效，在头颈部国际组的主持下进行了一项随机临床试验。（放射治疗肿瘤组、西南肿瘤组、东部肿瘤组、癌症和白血病组B、北方加州肿瘤组、东南集团）。符合条件的患者完全切除了口腔、口咽、下咽或喉的肿瘤。然后，他们被随机分配到接受三个周期的顺铂和5-FU化疗后，术后放疗（CT / RT）或术后单纯放疗（RT）。根据手术切缘是否大于或等于5 mm、是否存在囊外淋巴结延伸和/或手术切缘是否存在原位癌，将患者分为“低风险”或“高风险”治疗体积。对“低风险”体积给予50-54戈伊的辐射剂量，对“高风险”体积给予60戈伊的辐射剂量。共有442例可分析患者入组本研究，在本分析时，平均风险时间为45.7个月。RT组和CT / RT组的4年生存率分别为44%和48%（p = n.s.）。RT组4年无病生存率为38%，CT / RT组为46%（p = n.s.）。4年时，RT和CT / RT组的局部/区域失败率分别为29%和26%（p = n.s.）。RT组颈部淋巴结首次失败的发生率为10%，CT/RT组为5%（p = 0.03，未调整多重检验），RT组远端转移的总体发生率为23%，CT/RT组为15%（p = 0.03）。治疗相关的毒性进行了详细讨论，但在一般情况下，化疗是令人满意的耐受性，并没有影响到后续放疗的能力。未来的临床试验的影响进行了讨论。
To test the efficacy of sequential chemotherapy as an adjuvant to surgery and postoperative radiotherapy for patients with locally-advanced but operable squamous cell cancers of the head and neck region, a randomized clinical trial was conducted under the auspices of the Head and Neck Intergroup (Radiation Therapy Oncology Group, Southwest Oncology Group, Eastern Oncology Group, Cancer and Leukemia Group B, Northern California Oncology Group, and Southeast Group). Eligible patients had completely resected tumors of the oral cavity, oropharynx, hypopharynx, or larynx. They were then randomized to receive either three cycles of cis-platinum and 5-FU chemotherapy followed by postoperative radiotherapy (CT / RT) or postoperative radiotherapy alone (RT). Patients were categorized as having either "low-risk" or "high-risk" treatment volumes depending on whether the surgical margin was greater-than-or-equal-to 5 mm, there was extracapsular nodal extension, and / or there was carcinoma-in-situ at the surgical margins. Radiation doses of 50-54 Gy were given to "low-risk" volumes and 60 Gy were given to "high-risk" volumes. A total of 442 analyzable patients were entered into this study with the mean-time-at-risk being 45.7 months at the time of the present analysis. The 4-year actuarial survival rate was 44% on the RT arm and 48% on the CT / RT arm (p = n.s.). Disease-free survival at 4 years was 38% on the RT arm compared to 46% on the CT / RT arm (p = n.s.). At 4 years the local / regional failure rate was 29% vs. 26% for the RT and CT / RT arms, respectively (p = n.s.). The incidence of first failure in the neck nodes was 10% on the RT arm compared to 5% on the CT/RT arm (p = 0.03 without adjusting for multiple testing) and the overall incidence of distant metastases was 23% on the RT arm compared to 15% on the CT/RT arm (p = 0.03). Treatment related toxicity is discussed in detail, but, in general, the chemotherapy was satisfactorily tolerated and did not affect the ability to deliver the subsequent radiotherapy. Implications for future clinical trials are discussed.