Shao Weipeng, Liu Zhan, Li Bobo, Chen Feng, Liu Jie, Li Hui, Guo Hongbo
Department of Thoracic Surgical Ward II, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.
Front Oncol. 2024 Jul 16;14:1349300. doi: 10.3389/fonc.2024.1349300. eCollection 2024.
This study aimed to assess the role and effect of neoadjuvant targeted therapy (TT) versus targeted combined with chemotherapy (TC) for resectable EGFR-mutant non-small cell lung cancer (NSCLC).
Between March 2021 and June 2023, 20 patients with stage IA3-IIIB NSCLC were enrolled in the study. Eleven patients received EGFR-TKIs in the TT group, while nine patients received EGFR-TKIs and two cycles of cisplatin-based doublet chemotherapy (TC group). We compare the differences between the two groups through the following variables, including age, sex, surgical approach, postoperative complications, neoadjuvant therapy adverse events, complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), objective response rate (ORR), major pathologic response (MPR), and pathologic complete response (pCR).
Patients were predominantly female (75%) and never-smokers (95%). The average age was 59.2 years (range 46-79 years). Fifty-five percent harbored an exon 19 EGFR mutation and 45% an exon 21 mutation. The average targeted drug dosing time was 2.91 ± 1.7 (range 1-6) months in the TT group and 3.56 ± 3.54 (range 1-12) months in the TC group (P=0.598). The most common side effects were rash and diarrhea. No grade 5 events with neoadjuvant therapy were observed. The rate of R0 resection was 100% in all patients. Among the 11 patients in the TT group, 6 achieved a PR and 5 had SD, resulting in an ORR of 54.5%. Among the 9 patients in the TC group, 6 had PR and the remaining 3 had SD, resulting in an ORR of 66.6%. one patient (11.1%) in the TC group achieved pCR, while no patients in the TT group achieved pCR (P = 0.142). Two patients (18.2%) in the TT group reached MPR, and 2 patients (22.2%) in the TC group reached MPR (P = 0.257). The overall clinical downstage rate is 60%. Only 9 (45%) cases of yield clinical TNM (ycTNM) were consistent with yield pathologic TNM (ypTNM).
Results from this retrospective controlled research indicate that the neoadjuvant TT group is likely to be more effective outcomes and has safer profile in patients with EGFR-positive NSCLC than the neoadjuvant TC group. However, our results need to be validated in a multicenter, large sample prospective study.
本研究旨在评估新辅助靶向治疗（TT）与靶向联合化疗（TC）在可切除的表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）中的作用及效果。
2021年3月至2023年6月期间，20例IA3-IIIB期NSCLC患者纳入本研究。TT组11例患者接受EGFR酪氨酸激酶抑制剂（EGFR-TKIs）治疗，而TC组9例患者接受EGFR-TKIs及两个周期的以顺铂为基础的双联化疗。我们通过以下变量比较两组之间的差异，包括年龄、性别、手术方式、术后并发症、新辅助治疗不良事件、完全缓解（CR）、部分缓解（PR）、疾病稳定（SD）、疾病进展（PD）、客观缓解率（ORR）、主要病理缓解（MPR）及病理完全缓解（pCR）。
患者以女性（75%）和从不吸烟者（95%）为主。平均年龄为59.2岁（范围46 - 79岁）。55%患者存在EGFR外显子19突变，45%存在外显子21突变。TT组靶向药物平均给药时间为2.91±1.7（范围1 - 6）个月，TC组为3.56±3.54（范围1 - 12）个月（P = 0.598）。最常见的副作用为皮疹和腹泻。新辅助治疗未观察到5级事件。所有患者R0切除率为100%。TT组11例患者中，6例达到PR，5例为SD，ORR为54.5%。TC组9例患者中，6例达到PR，其余3例为SD，ORR为66.6%。TC组1例患者（11.1%）达到pCR，TT组无患者达到pCR（P = 0.142）。TT组2例患者（18.2%）达到MPR，TC组2例患者（22.2%）达到MPR（P = 0.257）。总体临床降期率为60%。仅9例（45%）临床TNM（ycTNM）与病理TNM（ypTNM）相符。
这项回顾性对照研究结果表明，对于EGFR阳性的NSCLC患者，新辅助TT组可能比新辅助TC组有更有效的结局且安全性更好。然而，我们的结果需要在多中心、大样本前瞻性研究中得到验证。
