PDF(Pubmed)
Abstract：
The objective of this study was to evaluate the relationship between pathologic response and survival in patients with clinical stage II/IIIA nonsquamous non-small-cell lung cancer (NSCLC) who intended to undergo neoadjuvant chemotherapy with bevacizumab, followed by surgery. In this phase II NAVAL study evaluating the feasibility of neoadjuvant chemotherapy with cisplatin (75 mg/m2), pemetrexed (500 mg/m2), and bevacizumab (15 mg/kg), followed by surgery, progression-free survival (PFS) and overall survival (OS) were assessed as the secondary endpoints. Patients were categorized based on the proportion of residual viable primary tumor in the resected specimen after neoadjuvant chemotherapy: those with residual tumor in less than one-third were classified as pathologic responders, the rest as nonresponders. Of the 30 patients, 25 underwent surgical resection after three cycles of neoadjuvant chemotherapy with bevacizumab; 5 did not undergo surgery. Among all 30 patients, the rates of 2- and 5-year PFS were 41.5% and 34.6%, respectively, and the rates of 2- and 5-year OS were 70.0% and 60.0%, respectively. A total of 6 patients (20%) were classified as pathologic responders; the other 24 (80%), as nonresponders. The five-year PFS differed significantly between pathologic responders (100%) and nonresponders (17.5%; p = 0.002). The five-year OS also differed significantly between pathologic responders (100%) and nonresponders (43.5%; p = 0.006). Pathologic response seems to be a predictor of survival. Long-term survival after surgery is expected for pathologic responders, whereas additional therapy is needed for nonresponders.
摘要：
这项研究的目的是评估临床II/IIIA期非鳞非小细胞肺癌（NSCLC）患者的病理反应与生存之间的关系，这些患者打算接受贝伐单抗的新辅助化疗。接下来是手术。在这项II期NAVAL研究中，评估了顺铂（75mg/m2）新辅助化疗的可行性，培美曲塞（500mg/m2），和贝伐单抗（15mg/kg），接着是手术,无进展生存期(PFS)和总生存期(OS)作为次要终点.根据新辅助化疗后切除标本中残留的原发肿瘤的比例对患者进行分类：那些残留肿瘤少于三分之一的患者被归类为病理反应者。其余的作为无应答者。在30名患者中，25例接受贝伐单抗新辅助化疗三个周期后接受手术切除；5例没有接受手术。在所有30名患者中，2年和5年PFS率分别为41.5%和34.6%，分别,2年和5年OS率分别为70.0%和60.0%，分别。共有6例患者（20％）被归类为病理反应者；其他24例（80％），作为无回应者。五年PFS在病理应答者（100％）和无应答者（17.5％；p=0.002）之间存在显着差异。病理反应者（100％）和无反应者（43.5％；p=0.006）之间的五年OS也存在显着差异。病理反应似乎是生存的预测因子。手术后的长期生存预计病理反应者，而无应答者需要额外的治疗。
