多西他赛、顺铂及同步推量放疗用于局部晚期头颈部鳞状细胞癌的I/II期研究

Phase I/II study of docetaxel, cisplatin, and concomitant boost radiation for locally advanced squamous cell cancer of the head and neck.

作者信息

Tsao Anne S, Garden Adam S, Kies Merrill S, Morrison William, Feng Lei, Lee J Jack, Khuri Fadlo, Zinner Ralph, Myers Jeffery, Papadimitrakopoulou Vassiliki, Lewin Jan, Clayman Gary L, Ang K Kian, Glisson Bonnie S

机构信息

Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.

出版信息

J Clin Oncol. 2006 Sep 1;24(25):4163-9. doi: 10.1200/JCO.2006.05.7851.

Abstract

PURPOSE

To investigate the feasibility of combining concomitant boost accelerated radiation with docetaxel and cisplatin and assess the regimen's toxicity, locoregional control rate, and survival in patients with locally advanced head and neck cancer (HNSCC).

PATIENTS AND METHODS

Patients with stage III-IV HNSCC were eligible. Phase I included two schedules of docetaxel and cisplatin: arm 1, once per week during weeks 1 to 4; arm 2, every 21 days for weeks 1 and 4. Radiation consisted of 72 Gy in 42 fractions over 6 weeks (concomitant boost).

RESULTS

Twenty patients were enrolled in phase I. The arm 1 maximum-tolerated dose (MTD) was defined at docetaxel 15 mg/m2 and cisplatin 20 mg/m2 based on prolonged mucositis in 29% of patients. The initial dose level in arm 2 was above the MTD. In total, 52 patients were treated using the arm 1 regimen in phase II. Acute toxicity included grade 3 mucositis and dermatitis in 81% and 44% of patients. The 2-year locoregional control rate was 71%. The 2-year progression-free and overall survival rates were 61% and 65%. Median survival was 37.8 months. Late effects included feeding tube dependence in 17% of patients alive and free of disease.

CONCLUSION

Locoregional control, survival, and acute toxicity with this regimen were comparable with other trials utilizing taxanes and/or platins and concomitant conventional or altered fractionation radiation. Our data suggest that chemotherapy added to concomitant boost fractionation may increase rates of long-term feeding tube dependence. Phase III trials are needed to assess the contribution of concomitant boost fractionation to chemoradiotherapy.

摘要

目的

探讨同步推量加速放疗联合多西他赛和顺铂治疗局部晚期头颈部癌(HNSCC)的可行性,并评估该方案的毒性、局部区域控制率和生存率。

患者与方法

III-IV期HNSCC患者符合入组条件。I期包括两种多西他赛和顺铂给药方案:1组,第1至4周每周1次;2组,第1周和第4周每21天1次。放疗为6周内分42次给予72 Gy(同步推量)。

结果

20例患者入组I期。基于29%的患者出现黏膜炎症延长,1组的最大耐受剂量(MTD)确定为多西他赛15 mg/m²和顺铂20 mg/m²。2组的初始剂量水平高于MTD。II期共有52例患者采用1组方案进行治疗。急性毒性包括81%的患者出现3级黏膜炎和44%的患者出现3级皮炎。2年局部区域控制率为71%。2年无进展生存率和总生存率分别为61%和65%。中位生存期为37.8个月。晚期效应包括17%存活且无疾病的患者依赖饲管进食。

结论

该方案的局部区域控制、生存率和急性毒性与其他使用紫杉烷和/或铂类以及同步传统或改变分割放疗的试验相当。我们的数据表明,同步推量分割放疗联合化疗可能会增加长期饲管依赖率。需要进行III期试验来评估同步推量分割放疗在放化疗中的作用。

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