Maoleekoonpairoj S, Phromratanapongse P, Puttanuparp S
Department of Medicine, Pramongkutklao Hospital, Phyathai, Bangkok, Thailand.
J Med Assoc Thai. 1997 Dec;80(12):778-84.
This prospective clinical trial was conducted in previously untreated patients with stage IV nasopharyngeal carcinoma (TNM classification), who received concurrent chemo-radiotherapy regimen of cisplatin and radiation, followed by adjuvant chemotherapy consisting of 5FU and cisplatin. The aim was to improve both disease free survival and overall survival. From July 1991 to June 1993, 28 patients with stage IV (T1-4N2-3 M0) squamous cell carcinoma or undifferentiated cell carcinoma of the nasopharynx were treated at the Pramongkutklao Hospital with radical radiotherapy and concurrent chemotherapy using cisplatin 100 mg/m2 on day 1 and 22 of radiotherapy. Adjuvant chemotherapy consisted of cisplatin 100 mg/m2 day 1 and 5FU 800 mg/m2 continuous intravenous infusion 24 hours for day 1-4 and repeated every 4 weeks, for 4 courses. All twenty eight cases had documented stage IV without distant metastases. 11/28 and 16/28 had T4 and N3 disease respectively. The initial response to concurrent chemo-radiotherapy was 100 per cent (27 CR, and 1 PR). With a median follow-up period of 58 months, the 2-year and 4-year survival rates were 85 per cent and 78 per cent respectively. Concurrent chemo-radiotherapy and adjuvant chemotherapy was well tolerated and without significant acute or chronic toxic effect, only a few patients had grade 3 and 4 mucositis and hematologic toxicity. At median time to follow-up of 58 months, seven patients developed loco-regional recurrence and two had distant metastases at the time of analysis. The results of this prospective study demonstrated that concurrent chemo-radiotherapy could induce a durable complete remission in a high proportion of patients with poor-prognosis stage IV nasopharyngeal carcinoma, resulting in an improved overall 2 and 4-year survival when compared to historical control of radiation therapy alone.
这项前瞻性临床试验针对的是先前未经治疗的IV期鼻咽癌患者（TNM分期），这些患者接受了顺铂与放疗同步的化疗方案，随后接受由5-氟尿嘧啶和顺铂组成的辅助化疗。目的是提高无病生存率和总生存率。1991年7月至1993年6月，28例IV期（T1-4N2-3 M0）鼻咽癌鳞状细胞癌或未分化细胞癌患者在诗里拉吉医院接受了根治性放疗和顺铂同步化疗，顺铂剂量为100mg/m²，分别在放疗的第1天和第22天使用。辅助化疗包括顺铂100mg/m²第1天，5-氟尿嘧啶800mg/m²持续静脉输注24小时，第1 - 4天，每4周重复一次，共4个疗程。所有28例病例均记录为IV期且无远处转移。分别有11/28和16/28的患者有T4和N3病变。同步放化疗的初始缓解率为100%（27例完全缓解，1例部分缓解）。中位随访期为58个月，2年和4年生存率分别为85%和78%。同步放化疗和辅助化疗耐受性良好，无明显急性或慢性毒性作用，仅有少数患者出现3级和4级粘膜炎和血液学毒性。在中位随访时间58个月时，7例患者出现局部区域复发，2例在分析时出现远处转移。这项前瞻性研究的结果表明，同步放化疗可使高比例预后不良的IV期鼻咽癌患者获得持久的完全缓解，与单纯放疗的历史对照相比，可提高总体2年和4年生存率。
