Intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer
Intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer
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DOI：
10.1200/jco.2003.01.008
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发表时间：
2003-01-01
影响因子：
45.3
通讯作者：
Forastiere, AA
中科院分区：
文献类型：
--
作者：
Adelstein, DJ;Li, Y;Forastiere, AA
目的：头颈部国际组进行了一项III期随机试验，以测试在不可切除的鳞状细胞头颈部癌患者中，在放疗基础上加用化疗的益处。（对照组），每日单次分次辐射（70戈伊，2戈伊/d）; B组，相同的放射治疗，同时推注顺铂，在第1、22和43天给药; C组，每日一次分割放疗和三个周期的同时输注氟尿嘧啶和顺铂化疗，第1周期30戈伊，第3周期30 ~ 40戈伊。如果可能，鼓励C组在第二个化疗周期后进行手术切除，如有必要，所有三个治疗组均作为挽救治疗。生存数据进行了比较，每个实验组和对照组使用单侧对数秩test.Results：在1992年和1999年之间，295例患者进入本试验。这不符合362例患者的招募目标，导致研究提前关闭。A组52%的患者发生3级或更严重的毒性，而8组为89%（P < .0001），C组为77%（P < .001）。中位随访时间为41个月，A组患者的3年预计总生存率为23%，而B组为37（P = 0.014），C组为27%结论：在常规的每日一次分次放疗的基础上同时使用高剂量、单药顺铂可显著提高生存率，但也会增加毒性。多药化疗或中期手术的可能性都不能抵消分程放疗导致的疗效损失。(C)2003年，美国临床肿瘤学会。
Purpose : The Head and Neck Intergroup conducted a phase III randomized trial to test the benefit of adding chemotherapy to radiation in patients with unresectable squamous cell head and neck cancer.Patients and Methods: Eligible patients were randomly assigned between arm A (the control), single daily fractionated radiation (70 Gy at 2 Gy/d); arm B, identical radiation therapy with concurrent bolus cisplatin, given on days 1, 22, and 43; and arm C, a split course of single daily fractionated radiation and three cycles of concurrent infusional fluorouracil and bolus cisplatin chemotherapy, 30 Gy given with the first cycle and 30 to 40 Gy given with the third cycle. Surgical resection was encouraged if possible after the second chemotherapy cycle on arm C and, if necessary, as salvage therapy on all three treatment arms. Survival data were compared between each experimental arm and the control arm using a one-sided log-rank test.Results: Between 1992 and 1999, 295 patients were entered on this trial. This did not meet the accrual goal of 362 patients and resulted in premature study closure. Grade 3 or worse toxicity occurred in 52% of patients enrolled in arm A, compared with 89% enrolled in arm 8 (P < .0001) and 77% enrolled in arm C (P < .001). With a median follow-up of 41 months, the 3-year projected overall survival for patients enrolled in arm A is 23%, compared with 37% for arm B (P = .0 14) and 27% for arm C (P = not significant).Conclusion: The addition of concurrent high-dose, single-agent cisplatin to conventional single daily fractionated radiation significantly improves survival, although it also increases toxicity. The loss of efficacy resulting from split-course radiation was not offset by either multiagent chemotherapy or the possibility of midcourse surgery. (C) 2003 by American Society of Clinical Oncology.