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术后放疗与顺铂同步放疗用于治疗伴有淋巴结转移的头颈癌的随机临床试验。

Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.

作者信息

Racadot Séverine, Mercier Mariette, Dussart Sophie, Dessard-Diana Bernadette, Bensadoun René-Jean, Martin Michel, Malaurie Emmanuelle, Favrel Véronique, Housset Martin, Durdux Catherine, Journel Catherine, Calais Gilles, Huet Jocelyne, Pillet Gérard, Hennequin Christophe, Haddad Elias, Diana Christian, Blaska-Jaulerry Brigitte, Henry-Amar Michel, Géhanno Pierre, Baillet François, Mazeron Jean-Jacques

机构信息

Centre Léon Bérard, Department of Radiation Oncology, Lyon, France.

出版信息

Radiother Oncol. 2008 May;87(2):164-72. doi: 10.1016/j.radonc.2007.12.021. Epub 2008 Jan 25.

DOI:10.1016/j.radonc.2007.12.021
PMID:18222010
Abstract

BACKGROUND AND PURPOSE

Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.

MATERIALS AND METHODS

The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50mg/m(2) administered by IV infusion twice weekly).

RESULTS

Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p=0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p=0.81).

CONCLUSIONS

Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.

摘要

背景与目的

术后放疗适用于头颈部癌症的治疗。在体外实验中,化疗可增强放疗的细胞毒性作用。我们报告了一项随机试验的结果,该试验比较了单纯术后放疗与顺铂同步放疗对伴有淋巴结转移的头颈部癌症的疗效。

材料与方法

本研究纳入了因头颈部癌症接受根治性手术且有淋巴结转移组织学证据的患者。患者被随机分为两组,一组单纯接受放疗(54 - 72Gy,30 - 40次分割,6 - 8周),另一组接受相同放疗方案并同步顺铂(50mg/m²,静脉输注,每周两次)。

结果

1994年2月至2002年6月,共纳入144例患者。中位随访时间为106个月(95%置信区间[92 - 119]),联合治疗组的2年局部区域控制率为73%(95%置信区间:0.61 - 0.84),放疗组为68%(95%置信区间:0.57 - 0.80)(p = 0.26)。两组的总生存率无显著差异(死亡风险比为1.05;95%置信区间:0.69 - 1.60;p = 0.81)。

结论

对于伴有淋巴结转移的头颈部癌症患者,术后放疗同步每周两次顺铂治疗并未提高局部控制率或总生存率。

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