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作 者:裴俊[1] 储天晴[1] 楼煜清[1] 施春雷[1] 熊丽纹[1] 韩宝惠[1] 顾爱琴[1]
出 处:《临床肺科杂志》2016年第11期2048-2052,共5页Journal of Clinical Pulmonary Medicine
摘 要:目的验证以下假设:治疗开始前的低水平血清VEGF预示存活时间较长,而环氧合酶-2(COX-2)抑制剂塞来昔布联合化疗能提高非小细胞肺癌(NSCLC)的缓解率和生存期。方法本试验为双盲单中心III期试验,选取81例IIIB或IV期NSCLC患者,ECOG体力状态评分为0-2入组。随机给予塞来昔布或安慰剂400 mg b.i.d联合4周期长春瑞滨/铂类化疗。塞来昔布计划给药时间最长1年,如疾病进展或出现严重毒性可停药。在治疗起始和4周期化疗结束后,检测所有患者血清VEGF水平。结果 81例患者治疗起始的VEGF水平中位值是340.98pg/m L。4周期化疗结束后VEGF平均值下降。总体生存期(OS)塞来昔布组vs安慰剂组为17.5月vs15.9月(P=0.837);无进展生存期(PFS)塞来昔布组vs安慰剂组为14.4月vs 7月(P=0.000)。治疗起始的VEGF水平≥340.98pg/m L组患者OS较VEGF水平<340.98pg/m L组差(13.2月vs 26月,P=0.000),PFS也缩短(3.5月vs8.5月,P=0.000)。结论治疗前血清VEGF低水平能预示塞来昔布对生存期的正效应。Objective To investigate the predictive value of serum VEGF in patients with advanced non-small cell lung cancer treated with vinorelbine. Methods A study was performed in patients with stage IIIb/IV NSCLC who had pathologic confirmation, no prior chemotherapy, Eastern Cooperative Oncology Group ( ECOG) per-formance status of 0 to 2, and adequate organ function. Treatment consisted of vinorelbine and cisplatin/carboplatin every 4 weeks for four cycles. Patients were randomly assigned to receive celecoxib 400 mg or placebo twice daily. Primary end point was overall survival ( OS) . Serum VEGF levels of all patients were detected at onset and endpoint of treatment. Results The median value of VEGF was 340. 98pg/ml before treatment. The mean value of VEGF de-creased after 4 cycles chemotherapy. The overall survival ( OS) of the celecoxib group was 17. 5m, longer than 15. 9m of the control group (P=0. 837). The progression free survival (PFS) of the celecoxib group was 14. 4m, longer than 7m of the control group (P=0. 000). OS of patients with high serum VEGF level (≥340. 98pg/mL) be-fore treatment was shorter than low VEGF level ( 〈340. 98pg/mL) (13. 2m vs 26m, P=0. 000). PFS was also poo-rer in the high VEGF group (3. 5m vs 8. 5m, P=0. 000). Conclusion In patients with advanced NSCLC, celecox-ib can not improve survival significantly. Low pre-treatment serum level of VEGF appears to be predictive of a posi-tive effect of celecoxib on survival.
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