替吉奥维持治疗对一线放化疗后局部晚期鼻咽癌患者的临床研究

Clinical trial of S-1 maintenance therapy for patients with locally advanced nasopharyngeal carcinoma after first-line radio-chemotherapy

目的观察局部晚期鼻咽癌患者进行标准放化疗后,用替吉奥作为维持治疗的有效性和安全性。方法入选2017年5月至2018年7月我院收治的28例放疗和一线化疗4～6周期后的局部晚期鼻咽癌患者。患者给予替吉奥维持治疗,根据体表面积确定替吉奥剂量(40～120 mg),给药2周后停药2周,共28d为1个疗程,计划治疗6个疗程。定期随访并记录患者的药物不良反应发生情况。结果 60. 7%的患者完成了6个周期的维持治疗。有1例患者复发。最常见的药物不良反应是厌食(53. 6%)和全身乏力(57. 1%); 1～2级白细胞降低发生率和中性粒细胞降低发生率分别为21. 4%和32. 1%; 1～2级恶心、呕吐及腹泻等胃肠道反应的发生率分别为42. 9%,14. 3%,14. 3%; 3级血液系统毒性2例,未观察到4级不良事件。结论局部晚期的鼻咽癌患者放化疗后给予6个周期替吉奥维持治疗,药物不良反应可耐受。需要进行进一步的随访来确定替吉奥否可以延长患者生存期。

Objective To evaluate the clinical efficacy and safety of S- 1 as maintenance therapy in nasopharyngeal carcinoma （NPC） pa- tients after standard radio - chemotherapy. Methods Twenty - eight NPC patients who have received standard radiochemotherapy in our hospi- tal were enrolled from May 2017 to July 2018. The treatment consisted of 6 courses （ a 2 - week administration and a 2 - week withdrawal, 28 d; 6 months） administered at 40 - 120 mg according to body surface area. Adverse drug reactions were recorded. Results The percentage of pa- tients that finished scheduled treatment for 6 months was 60. 7%. Recur- rence was noted in 1 patient. The most common tolerable adverse drug reactions were anorexia （ 53.6% ） and general fatigue （ 57. 1% ）. The incidence of leukopenia and neutropenia at 1 -2 grades were 21.4% and 32. 1%, the incidence of 1 -2 grade gastrointestinal reactions such as nausea, vomiting and diarrhea was 42. 9%, 14.3% , and 14.3% , Among them, there were 2 cases with grade 3 hematological toxieity l and no grade 4 adverse reactions were observed. Conclusion Adverse drug reactions was tolerable in NPC patients completing the 6 - course trea- tment of S - 1 after standard radio - chemotherapy. Longer follow - up is necessary to determine if S - 1 will have a significant survival benefit.