CAJ | 학술논문

目的研究吉非替尼治疗中国晚期非小细胞肺癌(NSCLC)患者的安全性和疗效.方法 2002年9月至2005年3月共入选晚期复发NSCLC患者120例,其中可评价疗效者103例.给予吉非替尼口服每次250 mg,每天1次,用药1个月后首次进行影像学疗效评价,此后每2～3个月复查影像学,直至出现病情进展或出现不能耐受的不良反应.停止吉非替尼治疗后,每6个月随访1次,直至患者死亡或随访结束.结果 103例患者的客观有效率为18.4%(19/103),疾病控制率为51.5%(53/103),中位疾病进展时间(TTP)为3个月(0.2～40个月),中位生存时间(MST)为9.8个月(0.5～51个月),1、2和3年生存率分别为44.7%、26.4%和13.2%.全组共有41例患者的TTP≥6个月,其MST为25.5个月.Cox多因素分析显示,腺癌、治疗后出现皮疹、体力状态(PS)评分<2分的患者具有更长的,TTP,而PS评分<2分、获得疾病控制的患者具有更长的生存期.本组患者的不良反应主要为皮疹、皮肤干燥、腹泻和转氨酶升高,多为Ⅰ～Ⅱ度.结论吉非替尼对于部分晚期复发的NSCLC患者有效,部分疾病控制者具有较长的生存期,而不良反应可耐受.
목적 연구길비체니치료중국만기비소세포폐암(NSCLC)환자적안전성화료효.방법 2002년9월지2005년3월공입선만기복발NSCLC환자120례,기중가평개료효자103례.급여길비체니구복매차250 mg,매천1차,용약1개월후수차진행영상학료효평개,차후매2～3개월복사영상학,직지출현병정진전혹출현불능내수적불량반응.정지길비체니치료후,매6개월수방1차,직지환자사망혹수방결속.결과 103례환자적객관유효솔위18.4%(19/103),질병공제솔위51.5%(53/103),중위질병진전시간(TTP)위3개월(0.2～40개월),중위생존시간(MST)위9.8개월(0.5～51개월),1、2화3년생존솔분별위44.7%、26.4%화13.2%.전조공유41례환자적TTP≥6개월,기MST위25.5개월.Cox다인소분석현시,선암、치료후출현피진、체력상태(PS)평분<2분적환자구유경장적,TTP,이PS평분<2분、획득질병공제적환자구유경장적생존기.본조환자적불량반응주요위피진、피부간조、복사화전안매승고,다위Ⅰ～Ⅱ도.결론 길비체니대우부분만기복발적NSCLC환자유효,부분질병공제자구유교장적생존기,이불량반응가내수.
Objective The aim of this study is to evaluate the efficacy and safety of Gefitinib in the treatment of Chinese patients with recurrent advanced non-small-cell lung cancer (NSCLC). Methods 120 patients were enrolled in this trial from September 2002 to March 2005, and 103 patients were evaluable. All patients were histologically or/and cytologically confirmed to have a locally advanced or metastatic NSCLC, and failed to previous standard treatments. The patients received orally 250 mg of Gefitinib once daily until the disease progression or intolerance to toxicity. First evaluation of response was undertaken one month after drug initiation, then every 2 or 3 months till disease progression. Each patient was followed up every 6 months untill death or end of follow-up. Results Among the 103 evaluable patients, the objective response rate was 18.4% (19/103), and the disease control rate was 51.5% (53/103). The median time to progression (mTTP) was 3 months (range: 0.2～40), the median survival time (MST) was 9.8 months (range: 0.5～51), the 1-, 2-, 3-year survival rates were 44.7%, 26.4% and 13.2%, respectively. The TIP of 41 patients was longer than 6 months with a MST of 25.5 months. The results of COX model analysis suggested that the patients with adenocarcinoma, rash and favourable performance status (PS) had longer TIP. The patients with favourable PS and well controlled disease had longer survival time. Adverse events included skin rash, dry skin, diarrhea and elevation of serum glutamate pyruvate transaminase (SGPT), and were usually mild. Conclusion Gefitinib is effective in treatment of patient with recurrent advanced NSCLC. The patients with controlled disease may achieve a long survival, and the adverse reactions are mild and tolerable.