Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer
Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer
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DOI：
10.1056/nejmoa071028
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发表时间：
2007-10-25
影响因子：
158.5
通讯作者：
Lefebvre, Jean-Louis
中科院分区：
文献类型：
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作者：
Vermorken, Jan B.;Remenar, Eva;Lefebvre, Jean-Louis
背景2期研究表明顺铂和氟尿嘧啶（PF）加多西他赛（TPF）的标准方案可改善头颈部鳞状细胞癌的预后。我们比较了TPF与PF作为诱导化疗的患者locoregially先进的，unrectable diseases.MethodsWe随机分配符合条件的患者年龄在18和70岁之间的III期或IV期疾病，没有远处转移，接受TPF（多西他赛和顺铂，第1天，氟尿嘧啶连续输注，第1至5天）或PF每3周4个周期。未出现疾病进展的患者在完成化疗后4 - 7周内接受放疗。主要终点是无进展生存率。ResultsA共358例患者进行随机分组，177人分配到TPF组和181 PF组。在中位随访32.5个月时，TPF组的中位无进展生存期为11.0个月，PF组为8.2个月（TPF组疾病进展或死亡的风险比为0.72; P = 0.007）。TPF治疗导致死亡风险降低27%（P = 0.02），中位总生存期为18.8个月，而PF组为14.5个月。TPF组中3级或4级白细胞减少症和中性粒细胞减少症事件较多，PF组中3级或4级血小板减少症、恶心、呕吐、口腔炎和听力丧失事件较多。毒性反应的死亡率分别为2.3%在TPF组和5.5%在PF group.ConclusionsAs相比，顺铂和氟尿嘧啶的标准方案，诱导化疗与多西他赛的加入显着提高无进展和总生存率的患者不可切除的鳞状细胞癌的头部和颈部。
BackgroundPhase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease.MethodsWe randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival.ResultsA total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P = 0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P = 0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group.ConclusionsAs compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck.