Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Sep 15;131(18):e70081.
doi: 10.1002/cncr.70081.

Real-world outcomes of neoadjuvant chemoimmunotherapy in patients with nonsmall cell lung cancer: Predictors of surgery, pathologic complete response, and event-free survival

Alissa J Cooper  1 , Edoardo Garbo  2 , Andrea Arfe  3 , Michael Conroy  4 , Narek Shaverdian  5 , Matthew Bott  6 , Teresa Gorria  2 , Federica Pecci  2 , Mihaela Aldea  2 , Valsamo Anagnostou  4 , Adam Schoenfeld  1 , Daniel Gomez  5 , Patrick M Forde  7 , Mark M Awad  2 , David R Jones  6 , Biagio Ricciuti  2 , Jamie E Chaft  1
Affiliations

Real-world outcomes of neoadjuvant chemoimmunotherapy in patients with nonsmall cell lung cancer: Predictors of surgery, pathologic complete response, and event-free survival

Alissa J Cooper et al. Cancer. .

Abstract

Background: Trials of neoadjuvant chemoimmunotherapy (chemoIO) have changed the standard of care for resectable nonsmall cell lung cancer (NSCLC). This study characterizes the outcomes of off-trial patients who received treatment with neoadjuvant chemoIO.

Methods: The authors analyzed records of patients with stage IB-III NSCLC who received neoadjuvant chemoIO with an intent to proceed to surgical resection at three US academic institutions. Clinical, demographic, and pathologic factors were incorporated in univariable and multivariable regression models to identify associations with outcomes (resection status, pathologic complete response [pCR], and subsequent event-free survival [EFS]) after standard-of-care neoadjuvant chemoIO.

Results: Analyses included 115 patients, of whom 63% had stage III disease, 77% completed three cycles of chemoIO, and 78% underwent surgical resection. Ages older than 72 years versus 64 years and younger were associated with not proceeding to surgery in univariable (p = .006) and multivariable (p = .014) regression analyses. Nineteen patients (17%) had tumors with a pCR, and 34 (30%) had a major pathologic response. Positive programmed death-ligand 1 (PD-L1) expression (≥50%; vs. negative PD-L1 expression: odds ratio, 12.1; 95% confidence interval, 2.0-73.7; p = .007) and KRAS mutations (vs. wild-type KRAS: odds ratio, 3.9; 95% confidence interval, 1.07-14.4; p = .039) were associated with a higher probability of pCR in univariable analysis. The median event-free survival was not reached and did not differ among subgroups stratified by key clinical variables.

Conclusions: The results from this study confirm the trial experience of high pCR rates after neoadjuvant chemoIO. This supports the use of chemoIO irrespective of KRAS mutation status, PD-L1 expression, and histology, but suggests that this approach may be less suitable for older patients.

Keywords: locally advanced; neoadjuvant chemoimmunotherapy; nonsmall cell lung cancer; pathologic complete response; surgical resectability.

PubMed Disclaimer

References

REFERENCES

    1. Marinelli D, Nuccio A, Di Federico A, et al. Improved event‐free survival after complete or major pathologic response in patients with resectable NSCLC treated with neoadjuvant chemoimmunotherapy regardless of adjuvant treatment: a systematic review and individual patient data meta‐analysis. J Thorac Oncol. 2024;20(3):285‐295. doi:10.1016/j.jtho.2024.09.1443
    1. Wakelee H, Liberman M, Kato T, et al. Perioperative pembrolizumab for early‐stage non‐small‐cell lung cancer. N Engl J Med. 2023;389(6):491‐503. doi:10.1056/nejmoa2302983
    1. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756‐1769. doi:10.1056/nejmoa2311926
    1. Heymach JV, Harpole D, Mitsudomi T, et al. Perioperative durvalumab for resectable non‐small‐cell lung cancer. N Engl J Med. 2023;389(18):1672‐1684. doi:10.1056/nejmoa2304875
    1. Banna GL, Hassan MA, Signori A, et al. Neoadjuvant chemo‐immunotherapy for early‐stage non‐small cell lung cancer: a systematic review and meta‐analysis. JAMA Netw Open. 2024;7(4):e246837. doi:10.1001/jamanetworkopen.2024.6837

MeSH terms