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neoSCI:可切除小细胞肺癌的新辅助或者转化免疫治疗
A multicenter, single-arm, open study of neoadjuvant or conversion atezolizumab in combination with chemotherapy in resectable small cell lung cancer (neoSCI) (Cohort Study)
Background: 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).
Methods: Prior to surgery, untreated patients with limited-stage SCLC received 3 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.
Results: Overall, thirteen of seventeen patients (including fourteen males and three females) underwent surgery. In the PP cohort, pCR and MPR were observed in eight (8/13, 61.5%) and twelve (12/13, 92.3%) patients, respectively. According to the intention-to-treat (ITT) analysis, the pCR and major pathological response (MPR) in the ITT cohort were 47.1% (8/17) and 70.6% (12/17), respectively. In addition, an ORR of 100% was recorded in the PP cohort. Moreover, fifteen (15/17, 88.2%) patients and one (1/17, 5.9%) in the ITT cohort attained partial remission (PR), and complete remission (CR), respecstively, with an overall response rate (ORR) of 94.1%. The median OS of the patients of pCR and the median EFS of the patients on surgery had not achieved. However, the median OS of the patients of non-pCR was 18.2 months and the median EFS of the non-surgical 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 (irAE, grade 1-2).
Conclusion: 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.
Duan H, Shi L, Shao C, Wang Y, Wang Z, Ni Y, Zhao J, Sun J, Tong L, Lei J, Jiang T, Liu Z, Yan X. A multicenter, single-arm, open study of neoadjuvant or conversion atezolizumab in combination with chemotherapy in resectable small cell lung cancer (neoSCI) (Cohort Study). Int J Surg. 2023 Jul 10;109(9):2641–9. doi: 10.1097/JS9.0000000000000501. Epub ahead of print. PMID: 37428211; PMCID: PMC10498862.
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