Tsutani Yasuhiro, Miyata Yoshihiro, Suzuki Kenji, Tanaka Fumihiro, Ito Hiroyuki, Yamashita Yoshinori, Okada Morihito
Department of Surgical Oncology, Hiroshima University, Hiroshima 734-8551, Japan.
Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama 589-8511, Japan.
Cancers (Basel). 2024 Jun 27;16(13):2363. doi: 10.3390/cancers16132363.
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/m), pemetrexed (500 mg/m), 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%; = 0.002). The five-year OS also differed significantly between pathologic responders (100%) and nonresponders (43.5%; = 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.
本研究的目的是评估临床II/IIIA期非鳞状非小细胞肺癌（NSCLC）患者在接受贝伐单抗新辅助化疗后再行手术时，病理反应与生存之间的关系。在这项II期NAVAL研究中，评估了顺铂（75mg/m²）、培美曲塞（500mg/m²）和贝伐单抗（15mg/kg）新辅助化疗后再行手术的可行性，无进展生存期（PFS）和总生存期（OS）被评估为次要终点。患者根据新辅助化疗后切除标本中残留存活原发性肿瘤的比例进行分类：残留肿瘤少于三分之一的患者被分类为病理反应者，其余为无反应者。30例患者中，25例在接受三个周期含贝伐单抗的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%）被分类为病理反应者；其他24例（80%）为无反应者。病理反应者和无反应者的五年PFS有显著差异（分别为100%和17.5%；P = 0.002）。病理反应者和无反应者的五年OS也有显著差异（分别为100%和43.5%；P = 0.006）。病理反应似乎是生存的一个预测指标。病理反应者手术后有望长期生存，而无反应者则需要额外治疗。
