Concomitant infusional paclitaxel and fluorouracil, oral hydroxyurea, and hyperfractionated radiation for locally advanced squamous head and neck cancer

Concomitant infusional paclitaxel and fluorouracil, oral hydroxyurea, and hyperfractionated radiation for locally advanced squamous head and neck cancer
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DOI:
10.1200/jco.2001.19.7.1961
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发表时间:
2001-04-01
影响因子:
45.3
通讯作者:
Vokes, EE
Vokes, EE
中科院分区:
医学1区
文献类型:
--
作者:
Kies, MS;Haraf, DJ;Vokes, EE

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目的:为了改善局部疾病控制和保留器官的生存率,我们进行了一项以紫杉烷为基础的化疗和超分割放疗方案的ct II期多机构试验。(IV期,98%; N2/3,81%)接受强化方案治疗,包括5天紫杉醇(120 mg/m2/d)和氟尿嘧啶(600 mg/m2/d)输注,口服羟基脲(500 mg/m2/d),每12小时1次,共11次,放疗剂量1.5戈伊,每日2次。在每个14天周期的第1天至第5天同时给予放化疗。一个完整的治疗过程包括在10周内的5个周期,总辐射剂量为72至75戈伊。结果:该组的中位随访时间为34个月。3年时,无进展生存率为63%,局部控制率为86%,全身控制率为79%;总生存率为60%。17名患者死于癌症复发,2名死于第二原发癌,4名死于其他原因。观察到的副作用包括贫血(22%需要输血),白细胞减少症(34%,3至4级)和粘膜炎(84%,3至4级)。保持了器官保存原则。在治疗后1年,61%的患者有复发性口干,47%的患者吞咽功能受损。在同一follow-uppoint.Conclusion T-FH 2X是一种高活性和耐受性的伴随化疗和超分割放射治疗方案,诱导持续的局部肿瘤控制,并有望提高生存与器官保存在高危患者的语音质量在97%的干扰。需要确定毒性较小的治疗方法和改善远距离疾病控制。T-FH 2X应在随机试验中进行测试,并与使用每日一次放射分割的强度较低的伴随方案进行比较。(C)2001年,美国临床肿瘤学会。
Purpose: To improve local disease control and survival with organ preservation, we conducted ct phase II multi-institutional trial with a concomitant taxane-based chemotherapy and hyperfractionated radiation regimen.Patients and Methods: Sixty-four patients with locally advanced squamous cancers (stage IV, 98%; N2/3, 81%) were treated on fin intensive regimen consisting of 5-day (120-hour) infusions of paclitaxel 120 mg/m(2)/d) and fluorouracil (600 mg/m2/d), oral hydroxyurea 500 mg every 12 hours for 11 doses, and radiation 1.5 Gy bid (T-FH2X). Chemoradiation was administered concomitantly on days 1 to 5 of each 14-day cycle. A full treatment course consisted of five cycles during a 10-week period to a total radiation dose of 72 to 75 Gy.Results: The median follow-up for the group is 34 months. At 3 years, progression-free survival is 63%, locoregional control is 86%, and systemic control is 79%; overall survival is 60%. Seventeen patients died of recurrent cancer, two died of second primary cancers, and four died of other causes. Side effects observed include anemia (22% required transfusion), leucopenia (34%, grade 3 to 4), and mucositis (84%, grade 3 to 4). Organ preservation principles were maintained. At 1 year posttreatment, 61% of patients had revere xerostomia and 47% had compromised swallowing. There was little disturbance of speech quality in 97% of patients at the same follow-up point.Conclusion T-FH2X is a highly active and tolerable concomitant chemotherapy and hyperfractionated radiation regimen that induces sustained local tumor control and holds promise for improved survival with organ preservation in high-risk patients. Identification of less toxic therapy and improved distant disease control are needed. T-FH2X should be tested in a randomized trial and compared with a less intensive concomitant regimen that uses once-daily radiation fractionation. (C) 2001 by American Society of Clinical Oncology.