Abstract
Neoadjuvant immunotherapy provides a unique opportunity for understanding therapeutic responses. We analyzed pathologic responses in surgical specimens obtained from 31 squamous non-small cell lung cancer (NSCLC) patients receiving neoadjuvant anti-PD-1 treatment. Fifteen (48.4%) patients achieved pathologic complete response (pCR) or major pathologic response (MPR). Among them, seven (46.7%) were assessed as radiological partial response and eight (53.3%) as stable disease. Among 20 patients with pathologically identified tumor beds in lymph nodes (LNs), 10 and six patients achieved pCR/MPR in primary tumors and paired LNs, respectively. pCR was achieved in 6/19 N1 nodes and 1/7 N2 nodes. Residual viable tumor (RVT) cells in 8/9 MPR specimens had 100% immune-activated phenotype, while a median of 80% of RVT cells in pathologic nonresponse specimens presented immune-excluded/desert phenotype. These findings demonstrated that assessment of pathologic responses in both primary tumor and LNs may be important as a surrogate for assessing neoadjuvant immunotherapeutic efficacy.
Highlights
Non-small-cell lung cancer (NSCLC) accounts for ~85% of all newly diagnosed lung cancers
Correlation of Residual viable tumor (RVT) with gross pathologic and radiographic tumor bed Surgical specimens of post-treatment primary tumor and lymph node were obtained from 31 patients with squamous NSCLC who received neoadjuvant anti-programmed death 1 (PD-1) therapy
Compared with the well-recognized pathologic response evaluation for neoadjuvant chemotherapy, the preliminarily immune-related pathologic response criteria (irPRC) has been recently defined by Cottrell and colleagues based on a pilot trial of neoadjuvant anti-PD-1 treatment in a small cohort of 20 NSCLC patients[13], in which 45% of patients achieved pathologic complete response (pCR)/major pathologic response (MPR), in adenocarcinoma, with 50% (6/12) pCR/MPR, but only 33.3% (2/6) for squamous NSCLC
Summary
Non-small-cell lung cancer (NSCLC) accounts for ~85% of all newly diagnosed lung cancers. Preliminary pilot studies have shown good efficacy with low adverse effects in NSCLC patients with neoadjuvant anti-PD-1 immunotherapies[8,9], including sintilimab, which is a recombinant humanized anti-PD-1 mAb that blocks interactions between PD-1 and its ligands. This antibody has been tested for safety and activity in patients with advanced solid tumors[10] and approved in China for lymphoma by the Chinese Center for Drug Evaluation in 2018
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