Real-world outcomes of immunotherapy-based neoadjuvant therapy in resectable non-small cell lung cancer

Jie Shen; Linping Gu; Yuwen Qi; Yaxian Yao; Shun Lu; Zhiwei Chen

doi:10.3389/fimmu.2023.1268251

Real-world outcomes of immunotherapy-based neoadjuvant therapy in resectable non-small cell lung cancer

Front Immunol. 2023 Sep 25:14:1268251. doi: 10.3389/fimmu.2023.1268251. eCollection 2023.

Authors

Jie Shen¹, Linping Gu¹, Yuwen Qi¹, Yaxian Yao¹, Shun Lu¹, Zhiwei Chen¹

Affiliation

¹ Department of Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

Abstract

Objectives: Recent clinical studies have demonstrated that immunotherapy-based neoadjuvant therapy have promising effectiveness for patients with resectable non-small cell lung cancer (NSCLC) in terms of pathologic response. Therefore, we performed this study to investigate whether immunotherapy-based neoadjuvant therapy is effective and safe for patients with resectable NSCLC.

Materials and methods: This open-label observational two-arm clinical study was performed at Shanghai Chest Hospital in China with patients who had resectable NSCLC and received two to three cycles of immunotherapy-based neoadjuvant therapy or neoadjuvant chemotherapy alone, followed by surgical resection. The primary endpoint was a major pathologic response (MPR). The secondary endpoints include a complete pathological response (pCR), a radiologic response to neoadjuvant therapy (TRR), event-free survival (EFS), and overall survival (OS).

Results: A total of 51 patients was included in this clinical study, of which 31 patients received immunotherapy-based neoadjuvant therapy and 20 patients received neoadjuvant chemotherapy alone. The percentage of patients achieving a major pathologic response was 41.9% with immunotherapy-based neoadjuvant therapy and 15.0% (95% CI, 0.008 to 0.468; P = 0.043) with neoadjuvant chemotherapy alone. The percentage of patients with pathologic complete response was 19.4% in the immunotherapy-based group and 5% (95% CI, -0.069 to 0.318; P = 0.223) in the chemotherapy group. The radiographic response rate was 71% after immunotherapy-based neoadjuvant therapy and 60% (95% CI, -0.143 to 0.359; P = 0.417) after neoadjuvant chemotherapy. At a median follow-up of 28 months, the median EFS and OS endpoints were not reached.

Conclusions: Neoadjuvant immunotherapy offers a considerable advantage over chemotherapy alone for resectable NSCLC in terms of the major pathologic response. Moreover, it did not enhance the risk of adverse events or hinder surgical resection.

Keywords: chemotherapy; clinical study; immunotherapy; neoadjuvant; non-small cell lung cancer (NSCLC).

Publication types

Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Non-Small-Cell Lung* / therapy
China
Humans
Immunotherapy / adverse effects
Lung Neoplasms* / therapy
Neoadjuvant Therapy

Grants and funding

The authors declare financial support was received for the research, authorship, and/or publication of this article. This work was supported by the Shanghai Chest Hospital Fund [grant number 2021YNJCM03], the Shanghai Lianxiang Public Welfare Foundation [grant number YXKY-ZX-0024], and the Beijing Science and Innovation Medical Development Foundation [grant number KC2021-JX-0186-36]. The funding sources had no role in this work.