Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects.
Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects.
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抗血管生成疗法与新辅助化疗相结合可提高 IIIA (N2) 期非小细胞肺癌的治疗效果，且不会增加不良反应
DOI：
10.18632/oncotarget.11547
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发表时间：
2016-09-20
期刊：
影响因子：
--
通讯作者：
Wang C
中科院分区：
文献类型：
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作者：
Zhao X;Su Y;You J;Gong L;Zhang Z;Wang M;Zhao Z;Zhang Z;Li X;Wang C
为评价恩度抗血管生成治疗联合新辅助化疗治疗IIIA（N2）期NSCLC的安全性和有效性，我们对30例NSCLC患者进行了一项随机、对照、开放标签的临床研究。患者被随机分配到试验组或对照组，分别接受两个周期的NP新辅助化疗方案联合Endostar或NP方案，比例为2：1。3周后评估疗效，4周内手术切除，26例患者成功完成治疗。虽然实验组之间的总缓解率（RR）和临床获益率（CBR）没有差异，但试验组的总肿瘤消退率（TRR）高于对照组。试验组和对照组的中位DFS和OS也没有差异。试验组和对照组的临床围手术期指标（包括术中失血量、淋巴结清扫组数量、术后留置导管使用时间和术后出院时间）相当。最后，血液学和非血液学毒性以及术后病理学指标，包括降级率、完全切除率和转移淋巴结率，在两组之间也没有差异。总体而言，恩度联合NP新辅助化疗可提高IIIA-N2期NSCLC患者的疗效，而不会增加不良反应。本研究注册于ClinicalTrials.gov（编号NCT 02497118）。
To evaluate the safety and efficacy of combining Endostar antiangiogenic therapy with neoadjuvant chemotherapy for the treatment of stage IIIA (N2) NSCLC, we conducted a randomized, controlled, open-label clinical study of 30 NSCLC patients. Patients were randomly assigned to the test or control groups, which received either two cycles of an NP neoadjuvant chemotherapy regimen combined with Endostar or the NP regimen alone, respectively, at a 2:1 ratio. Efficacy was assessed after 3 weeks, and surgical resection occurred within 4 weeks, in the 26 patients who successfully completed treatment. While total response rates (RR) and clinical benefit rates (CBR) did not differ between the experimental groups, total tumor regression rates (TRR) were higher in the test group than in the control group. Median DFS and OS also did not differ between the test and control groups. Clinical perioperative indicators, including intraoperative blood loss, number of dissected lymph node groups, duration of postoperative indwelling catheter use, and time to postoperative discharge, were comparable in the test and control groups. Finally, hematological and non-hematological toxicities and postoperative pathological indicators, including down-staging ratio, complete resection ratio, and metastatic lymph node ratio, also did not differ between the groups. Overall, combining Endostar with NP neoadjuvant chemotherapy increased therapeutic efficacy without increasing adverse effects in stage IIIA-N2 NSCLC patients. This study is registered with ClinicalTrials.gov (number NCT02497118).