文章：

贝伐单抗新辅助化疗后手术治疗临床II/IIIA期非鳞状非小细胞肺癌的病理反应与生存分析：一项II期可行性研究（NAVEL）结果

Pathologic Response and Survival after Neoadjuvant Chemotherapy with Bevacizumab Followed by Surgery for Clinical Stage II/IIIA Nonsquamous Non-Small-Cell Lung Cancer: Results from a Phase II Feasibility Study (NAVAL)

原文发布日期：27 June 2024

DOI: 10.3390/cancers16132363

类型: Article

开放获取: 是

英文摘要：

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.

摘要翻译： 

本研究旨在评估临床II/IIIA期非鳞状非小细胞肺癌（NSCLC）患者在接受贝伐珠单抗新辅助化疗后手术的病理缓解与生存之间的关系。在这项评估顺铂（75 mg/m²）、培美曲塞（500 mg/m²）和贝伐珠单抗（15 mg/kg）新辅助化疗后手术可行性的II期NAVAL研究中，无进展生存期（PFS）和总生存期（OS）被设定为次要终点。根据新辅助化疗后切除标本中残留存活原发肿瘤的比例，患者被分为两组：残留肿瘤少于三分之一的被归类为病理缓解者，其余为非缓解者。在30例患者中，25例在完成三个周期的贝伐珠单抗新辅助化疗后接受了手术切除；5例未接受手术。在所有30例患者中，2年和5年PFS率分别为41.5%和34.6%，2年和5年OS率分别为70.0%和60.0%。共有6例患者（20%）被归类为病理缓解者；其余24例（80%）为非缓解者。病理缓解者（100%）与非缓解者（17.5%）的五年PFS存在显著差异（p=0.002）。病理缓解者（100%）与非缓解者（43.5%）的五年OS也存在显著差异（p=0.006）。病理缓解似乎是生存的预测因子。病理缓解者有望在手术后获得长期生存，而非缓解者则需要进一步治疗。

原文链接：

Pathologic Response and Survival after Neoadjuvant Chemotherapy with Bevacizumab Followed by Surgery for Clinical Stage II/IIIA Nonsquamous Non-Small-Cell Lung Cancer: Results from a Phase II Feasibility Study (NAVAL)