摘要
背景:临床前和临床研究结果显示重组人血管内皮抑制素能抑制血管内皮细胞增殖、血管生成和肿瘤生长,且耐受性良好。目的:评价重组人血管内皮抑制素联合FOLFOX4方案治疗晚期结直肠癌(ACRC)的反应率(RR)、临床获益率(CBR)、中位疾病进展时间(TTP)和肿瘤进展率,观察患者生活质量(QOL)改善情况和药物不良反应。方法:收集50例病理学诊断为Ⅳ期、初治或复治、Karnofsky评分(KPS)≥60分的ACRC患者,随机分为试验组和对照组。试验组25例,联合应用FOLFOX4方案和重组人血管内皮抑制素(7.5 mg/m^2,d_(1～14))。对照组25例,应用FOLFOX4方案+安慰剂(0.9%NaCl溶液,用法同重组人血管内皮抑制素)。结果:50例患者均可评价疗效。试验组总RR(44.0%对16.0%,P=0.062)、总CBR(76.0%对48.0%,P=0.041)、总中位TTP(7.8个月对5.0个月,P=0.040)和QOL改善率(64.0%对36.0%,P=0.048)均高于对照组,肿瘤进展率低于对照组(P<0.05)。初治患者中,试验组RR、CBR和中位TTP均显著高于对照组(P<0.05);复治患者中,试验组和对照组上述指标无明显差异。两组间不良反应发生率差异无统计学意义。结论:重组人血管内皮抑制素联合FOLFOX4方案能明显提高ACRC患者,尤其是初治患者的RR,延长中位TTP,在一定程度上改善患者的QOL,且安全性较好。
Background： Both pre-clinieal and clinical studies indicated that recombinant human endostatin （rh-endostatin） could inhibit endothelial cell proliferation, angiogenesis, tumor growth and with security assurance in clinical use. Aims： To assess the response rate （RR）, clinical benefit rate （CBR）, median time to progression （TIP） and progression rate of advanced colorectal cancer （ACRC） patients treated with rh-endostatin plus FOLFOX4 regimen, and to observe the improvement in quality of life （QOL） and adverse effects. Methods： Fifty histologically proven stage IV, initial treatment or retreatment ACRC patients with Karnofsky Performance Status （KPS） ≥60 were randomly allocated to treatment group or control group. The treatment group （25 patients） received rh-endostatin （7.5 mg/m^2 on day 1 to 14） plus FOLFOX4 regimen, while the control group were receiving FOLFOX4 regimen plus placebo （normal saline, with the same dosage as rh- endostatin）. Results： Of the 50 assessable patients, overall RR, CBR, median TIP and improvement of QOL in treatment group （44.0%, 76.0%, 7.8 months and 64.0%） were much higher than those in control group （16.0%, 48.0%, 5.0 months and 36.0%, P=0.062, 0.041, 0.040 and 0.048, respectively）, whereas the progression rate of tumor was much lower in the treatment group （P〈O.05）. In untreated ACRC patients, RR, CBR and median TIP in treatment group were significantly increased than those in control group （P〈0.05）; whereas in previously treated ACRC patients, no significant difference was observed between these two groups. There were no significant differences in adverse effects between these two groups. Conclusions： rh-endostatin plus FOLFOX4 regimen is safe and can significantly improve RR, median TIP and QOL as compared with FOLFOX4 alone in ACRC, especially untreated ACRC patients.
出处
《胃肠病学》
2009年第8期453-457,共5页
Chinese Journal of Gastroenterology
