Induction chemotherapy followed by concomitant radiotherapy and weekly cisplatin versus the same concomitant chemoradiotherapy in patients with nasopharyngeal carcinoma: a randomized phase II study conducted by the Hellenic Cooperative Oncology Group (HeCOG) with biomarker evaluation

Induction chemotherapy followed by concomitant radiotherapy and weekly cisplatin versus the same concomitant chemoradiotherapy in patients with nasopharyngeal carcinoma: a randomized phase II study conducted by the Hellenic Cooperative Oncology Group (HeCOG) with biomarker evaluation
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DOI:
10.1093/annonc/mdr116
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发表时间:
2012-02-01
期刊:
影响因子:
50.5
通讯作者:
Ciuleanu, T.
Ciuleanu, T.
中科院分区:
医学1区
文献类型:
--
作者:
Fountzilas, G.;Ciuleanu, E.;Ciuleanu, T.

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背景:局部晚期鼻咽癌(LA-NPC)患者同时接受放射治疗(RT)和顺铂化疗(CCRT)被认为是标准治疗方法。患者和方法:141例符合条件的LA-NPC患者被随机分为三个周期,分别接受顺铂75 mg/m(2)、表阿霉素75 mg/m(2)和紫杉醇175 mg/m(2)的诱导化疗(CEP),然后进行确定的RT(70GyR),同时每周滴注顺铂40 mg/m(2)(研究组,72例)或仅接受相同的CCRT方案(对照组,结果:62例(86%)患者接受了3个周期的IC治疗。完成放射治疗的患者数两组间差异无统计学意义(61例对,P=0.18)。两组的总体和完全缓解率非常相似,3年无进展和总存活率也非常相似。除脱发外,IC的III或IV级毒性反应很少见。黏膜炎、体重减轻和白细胞减少是CCRT最显著的副作用。结论:与单纯CCRT相比,CCRT加三个周期CEP的IC治疗并不能显著提高有效率和/或生存率。
Background: Concomitant administration of radiation therapy (RT) and chemotherapy with cisplatin (CCRT) is considered standard treatment in patients with locally advanced nasopharyngeal cancer (LA-NPC). The role of induction chemotherapy (IC) when followed by CCRT in improving locoregional control remains controversial.Patients and methods: Totally, 141 eligible patients with LA-NPC were randomized to either three cycles of IC with cisplatin 75 mg/m(2), epirubicin 75 mg/m(2) and paclitaxel (Taxol) 175 mg/m(2) (CEP) every 3 weeks followed by definitive RT (70 Gy) and concomitant weekly infusion of cisplatin 40 mg/m(2) (investigational arm, 72 patients) or to the same CCRT regimen alone (control arm, 69 patients).Results: Sixty-two patients (86%) received three cycles of IC. No difference between the arms was observed in the number of patients who completed RT (61 versus 64, P = 018). Overall and complete response rates were very similar in the two arms and so were 3-year progression-free and overall survival rates. Grade III or IV toxic effects from IC were infrequent, apart of alopecia. Mucositis, weight loss and leukopenia were the most prominent side-effects from CCRT.Conclusion: IC with three cycles of CEP when followed by CCRT did not significantly improve response rates and/or survival compared with that of CCRT alone.