Department of Thoracic Surgery at Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi.
Department of Oncology at Beijing Chest Hospital, Capital Medical University, Beijing, China.
Int J Surg. 2023 Sep 1;109(9):2641-2649. doi: 10.1097/JS9.0000000000000501.
This study aimed to investigate the prospects of using chemotherapy in combination with atezolizumab in the neoadjuvant or conversion treatment of small cell lung cancer (SCLC).
Prior to surgery, untreated patients with limited-stage SCLC received three cycles of neoadjuvant or conversion atezolizumab combined with chemotherapy of etoposide and platinum. The primary endpoint of the trial was pathological complete response (pCR) in the per-protocol (PP) cohort. In addition, safety was assessed based on treatment-related adverse events (AEs) and postoperative complications.
Overall, 13 of 17 patients (including 14 males and 3 females) underwent surgery. In the PP cohort, pCR and major pathological response were observed in 8 (8/13, 61.5%) and 12 (12/13, 92.3%) patients, respectively. According to the intention-to-treat (ITT) analysis, the pCR and major pathological response in the ITT cohort were 47.1% (8/17) and 70.6% (12/17), respectively. In addition, an overall response rate of 100% was recorded in the PP cohort. Moreover, 15 (15/17, 88.2%) patients and 1 (1/17, 5.9%) in the ITT cohort attained partial remission (PR), and complete remission, respectively, with an overall response rate of 94.1%. The median overall survival of the patients of pCR and the median event-free survival of the patients on surgery had not achieved. However, the median overall survival of the patients of non-pCR was 18.2 months and the median event-free survival of the nonsurgical patients was 9.5 months. During the neoadjuvant treatment, the incidence of grade 3 or higher AEs was 58.8% (10/17). Additionally, three patients (17.6%) developed immune-related adverse event (grades 1-2).
In patients with SCLC, neoadjuvant or conversion atezolizumab combined with chemotherapy significantly improved pCR with manageable AEs. Therefore, this regimen may be considered a safe and effective treatment for SCLC.
本研究旨在探讨在小细胞肺癌（SCLC）的新辅助或转化治疗中联合使用化疗和阿替利珠单抗的前景。
未经治疗的局限期 SCLC 患者在术前接受三周期新辅助或转化阿替利珠单抗联合依托泊苷和铂类化疗。该试验的主要终点是方案人群（PP）的病理完全缓解（pCR）。此外，还根据治疗相关不良事件（AE）和术后并发症评估安全性。
总体而言，17 例患者中有 13 例（包括 14 例男性和 3 例女性）接受了手术。在 PP 队列中，8 例（8/13，61.5%）和 12 例（12/13，92.3%）患者达到了 pCR 和主要病理缓解。根据意向治疗（ITT）分析，ITT 队列的 pCR 和主要病理缓解率分别为 47.1%（8/17）和 70.6%（12/17）。此外，PP 队列的总缓解率为 100%。此外，PP 队列中 15 例（15/17，88.2%）和 ITT 队列中 1 例（1/17，5.9%）患者达到部分缓解（PR），总缓解率为 94.1%。pCR 患者的中位总生存期和手术患者的中位无事件生存期尚未达到。然而，非 pCR 患者的中位总生存期为 18.2 个月，非手术患者的中位无事件生存期为 9.5 个月。新辅助治疗期间，3 级或以上 AE 的发生率为 58.8%（10/17）。此外，3 例（17.6%）患者发生免疫相关不良事件（1-2 级）。
在 SCLC 患者中，新辅助或转化阿替利珠单抗联合化疗显著提高了 pCR 率，且 AE 可管理。因此，该方案可能是治疗 SCLC 的一种安全有效的方法。
