DOI: 10.1097/cm9.0000000000004185 ISSN: 0366-6999

Efficacy and safety of adjuvant immunotherapy after pathological complete response following neoadjuvant chemoimmunotherapy in patients with resectable NSCLC: A real-world observational study

Juan Jiang, Ziyu Zhang, Jun Zeng, Lemeng Zhang, Xingxiang Pu, Jian An, Yanwu Zhou, Pengbo Deng, Ruimin Chang, Mingxuan Xie, Xiaoxiong Xiao, Liming Cao, Yuanda Cheng, Huaping Yang, Chengping Hu, Yang Gao, Min Li

Abstract

Background:

Achieving a pathological complete response (pCR) following neoadjuvant chemoimmunotherapy is closely associated with improved long-term outcomes in resectable non-small cell lung cancer (NSCLC). It remains unclear whether the addition of adjuvant immunotherapy will improve survival in patients with a pCR.

Methods:

In this real-world observational study, we enrolled 145 consecutive patients diagnosed with resectable stage IB–IIIB NSCLC who achieved a pCR after three cycles of neoadjuvant chemoimmunotherapy and subsequently received surgery between July 2020 and December 2023. Patients were assigned to two groups based on whether they received adjuvant immunotherapy (i.e. neoadjuvant-adjuvant group and neoadjuvant-only group). Disease-free survival (DFS) and overall survival (OS) were compared between the two groups after inverse probability of treatment weighting (IPTW), and treatment-related adverse events (TRAEs) were summarized.

Results:

A total of 145 patients were included in the final analysis, and 81 patients (55.9%) received adjuvant immunotherapy after achieving pCR. The median follow-up duration for the whole cohort was 39.0 months. Neither group reached a median DFS, and no DFS benefit favoring the neoadjuvant-adjuvant strategy over neoadjuvant-only strategy was observed ( P = 0.801) after applying IPTW. Similarly, no significant difference in OS was observed between the two groups ( P = 0.231). The addition of adjuvant immunotherapy did not lead to a significant increase in any-grade, grade ≥3, or severe TRAEs.

Conclusions:

This study found that the addition of adjuvant immunotherapy did not demonstrate a significant improvement in DFS or OS in NSCLC patients who achieved a pCR after preoperative chemoimmunotherapy. However, larger prospective studies are required to confirm these results due to the limited sample size and low number of events.

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