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目的:评价重组人血管内皮抑制素注射液Ⅳ期临床试验中对非小细胞肺癌的有效性和安全性。方法:入组恩度Ⅳ期临床试验的2 725例人群中,我院42例患者接受恩度联合标准一、二线含铂化疗方案,恩度静脉滴注,7.5mg/㎡/天,连续给药14天,21天为一周期重复给药。结果:可评价疗效的38例患者客观反应率为28.6%,疾病控制率为73.8%,42例患者中位无疾病进展生存时间5.3个月,中位总生存时间为8.0个月,1、2、3年生存率分别为40.5%、18.8%及10.7%。PS评分良好(0~1分)、近期疗效评价临床有效组(CR+PR)患者及恩度使用≥4周期的患者具有更长的无疾病进展生存时间,分别是5.6月、7.4月和7.0月(P<0.05),PS评分是患者的唯一独立预后因素。发生Ⅲ/Ⅳ度不良反应主要为化疗相关的胃肠道反应9.5%,白细胞减少38.1%,贫血26.2%,血小板减少2.4%。结论:恩度联合化疗治疗晚期非小细胞肺癌在我院的Ⅳ期临床试验数据显示恩度联合化疗可以在毒副作用可耐受的情况下,使患者的临床受益增加,近期的肿瘤控制转换为生存的获益,且治疗效果与恩度使用周期数、患者一般状况相关。
OBJECTIVE: To evaluate the efficacy and safety of recombinant human endostatin in Phase IV clinical trial of non-small cell lung cancer. Methods: Of the 2 725 patients enrolled in phase Ⅳ clinical trial, 42 patients in our hospital underwent first-line and second-line platinum-based chemotherapy regimen. Endostar was administered intravenously at 7.5 mg / ㎡ / day for continuous Medicine for 14 days, 21 days for a cycle of repeated administration. Results: The objective response rate of 38 patients with evaluable efficacy was 28.6%, the disease control rate was 73.8%, the median progression-free survival time of 42 patients was 5.3 months, the median overall survival time was 8.0 months, 1,2 The 3-year survival rates were 40.5%, 18.8% and 10.7% respectively. PS scores were good (0 to 1). Patients in the clinically effective group (CR + PR) with recent efficacy evaluations and those with ≥ 4 cycles of endurance use had longer disease-free progression-free survival times of 5.6, 7.0, and 7.0 Month (P <0.05). PS score was the only independent prognostic factor in patients. The incidence of grade III / IV adverse reactions was mainly associated with chemotherapy-related gastrointestinal reactions 9.5%, leukopenia 38.1%, anemia 26.2%, and thrombocytopenia 2.4%. Conclusions: Endostar combined with chemotherapy for advanced non-small cell lung cancer in our hospital in phase Ⅳ clinical trial data show that Endood combined with chemotherapy can tolerate side effects in patients with clinical benefit to patients increased, the recent conversion of tumor control to Survival benefits, and the treatment effect and the grace of the number of cycles, the general condition of the patient.