II期和III期头颈癌同步使用羟基脲和氟尿嘧啶的放射治疗

Radiation therapy with concomitant hydroxyurea and fluorouracil in stage II and III head and neck cancer.

作者信息

Haraf D J, Kies M, Rademaker A W, Stenson K, Mittal B, Pelzer H, Wenig B, Witt M E, Sulzen L, Weichselbaum R R, Vokes E E

机构信息

Department of Radiation and Cellular Oncology, University of Chicago, IL, USA.

出版信息

J Clin Oncol. 1999 Feb;17(2):638-44. doi: 10.1200/JCO.1999.17.2.638.

DOI:10.1200/JCO.1999.17.2.638

PMID:10080609

Abstract

PURPOSE

In 1986, a multi-institutional phase II trial was begun to study the use of chemotherapy with concomitant radiation in patients with stage II and III head and neck cancer. End points were overall survival, progression-free survival, local/regional control, and toxicity in the setting of organ preservation with concomitant treatment.

METHODS

Eligible patients with stage II or III disease received chemotherapy and radiation on a 2-week cycle. Chemotherapy consisted of continuous infusion fluorouracil (5-FU) at 800 mg/m2/d for 5 consecutive days (days 1 to 5) and hydroxyurea (HU) at 1 g orally every 12 hours for 13 doses starting the evening before the start of irradiation. Radiation therapy was given as single 1.8- to 2.0-Gy fractions for 5 consecutive days (days 1 to 5) with chemotherapy. Each 5 days of treatment was followed by a 9-day break (days 6 to 14), during which no additional treatment was given. Treatment cycles were repeated until the completion of the planned radiation dose (six to eight cycles).

RESULTS

Between 1989 and 1996, 60 patients were enrolled. All patients were eligible for analysis, with a median follow-up of 52 months for surviving patients and 42 months for all patients. Grade 3 to 4 mucositis occurred in 57% of patients. The 5 year-actuarial overall survival, progression-free survival, and local/regional control were 65%, 82%, and 86%, respectively. Eight patients developed local and/or regional recurrence after treatment. Surgical salvage was possible in three of these patients. Thus, the ultimate 5-year local/ regional control was 91%.

CONCLUSION

Concomitant radiation and chemotherapy with 5-FU and HU is an effective regimen in patients with stage II and III head and neck cancer. Progression-free survival and local/regional control appear to be superior to expected rates in patients treated with surgery and radiation. Further testing of this regimen in a phase III setting is indicated.

摘要

目的

1986年启动了一项多机构II期试验，以研究化疗联合放疗在II期和III期头颈癌患者中的应用。终点指标为总生存期、无进展生存期、局部/区域控制率以及在联合治疗保器官情况下的毒性反应。

方法

符合条件的II期或III期疾病患者每2周接受一次化疗和放疗。化疗包括连续5天（第1至5天）以800mg/m²/d的剂量持续输注氟尿嘧啶（5-FU），以及从放疗开始前一晚起每12小时口服1g羟基脲（HU），共13剂。放疗在化疗期间连续5天（第1至5天）每天给予单次1.8至2.0Gy的分次照射。每5天的治疗后有9天休息期（第6至14天），此期间不给予额外治疗。治疗周期重复进行，直至完成计划的放疗剂量（六至八个周期）。

结果

1989年至1996年期间，共入组60例患者。所有患者均符合分析条件，存活患者的中位随访时间为52个月，所有患者的中位随访时间为42个月。57%的患者发生3至4级黏膜炎。5年精算总生存期、无进展生存期和局部/区域控制率分别为65%、82%和86%。8例患者治疗后出现局部和/或区域复发。其中3例患者可行手术挽救。因此，最终的5年局部/区域控制率为91%。