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Published on: September 25, 2018
Is neoadjuvant immunotherapy necessary in patients with programmed death ligand 1 expression-negative resectable
Shu-Ling Zhang1, Yuan Tian1, Jing Yu1
1Department of Oncology, Shengjing Hospital of China Medical University, Shenyang 110004, China.
Objectives:
The aim of this study was to investigate the clinical benefit and necessity of neoadjuvant programmed cell death (or ligand) (PD-(L)1) blockades in resectable non-small cell lung cancer (NSCLC) patients with negative PD-L1 expression.
Materials And Methods:
Randomized control trials (RCTs) that compared event-free survival (EFS), overall survival (OS), major pathological response (MPR), and/or pathological complete response (pCR) between neoadjuvant chemo-immunotherapy (nCIT) and neoadjuvant chemotherapy (nCT) for patients with resectable NSCLC stratified by PD-L1 expression were eligible for inclusion in the study. Data regarding the pathological response and EFS were evaluated by the odds ratio (OR) and hazard ratio (HR) with 95% confidence interval (CI) using random and fixed models.
Results:
A total of six RCTs involving 3,194 patients with resectable NSCLC with or without neoadjuvant immunotherapy were included. Compared with nCT alone, nCIT significantly improved pCR (18.3 % vs. 3.0 %; OR, 5.64; 95 % CI, 3.22-9.89; P < 0.001), MPR (38.9 % vs. 15.5 %; OR, 3.57; 95 % CI, 2.10-6.05; P < 0.001), and EFS (HR, 0.75; 95 % CI, 0.62-0.90; P = 0.002) in PD-L1 <1 % NSCLC patients. In addition, PD-L1 ≥1 % was associated with higher rates of pCR (32.8 % vs. 18.3 %; OR, 2.28; 95 % CI, 1.40-3.73; P = 0.001) and MPR (53.9 % vs. 38.9 %; OR, 1.84; 95 % CI, 1.22-2.79; P = 004) and longer EFS (HR, 0.44 vs. 0.75) in the setting of nCIT compared with PD-L1 <1 %. nCIT improved only OS in NSCLC patients with PD-L1 ≥1 % but not in patients with PD-L1 <1 %.
Conclusions:
The use of nCIT should be recommended for resectable NSCLC patients with negative PD-L1 expression, as nCIT significantly improved the pathological response and EFS in these patients. The benefit to PD-L1-negative patients treated with nCIT on OS remains to be validated.
Insights
Neoadjuvant chemo-immunotherapy (nCIT) significantly improves pathological response and event-free survival (EFS) in resectable non-small cell lung cancer (NSCLC) patients with negative PD-L1 expression. Further research is needed to validate the overall survival benefits for this group.
Area of Science:
- Oncology
- Immunotherapy
- Thoracic Surgery
Background:
- Resectable non-small cell lung cancer (NSCLC) treatment typically involves surgery.
- Neoadjuvant chemotherapy (nCT) is used to downstage tumors and improve resectability.
- The role of neoadjuvant programmed cell death (ligand) (PD-(L)1) blockade in NSCLC, particularly in PD-L1 negative cases, requires further investigation.
Purpose of the Study:
- To evaluate the clinical benefit of neoadjuvant chemo-immunotherapy (nCIT) versus neoadjuvant chemotherapy (nCT) in resectable NSCLC patients with negative PD-L1 expression.
- To assess the impact of nCIT on pathological response and survival outcomes stratified by PD-L1 expression levels.
Main Methods:
- A systematic review and meta-analysis of randomized control trials (RCTs) comparing nCIT and nCT.
- Inclusion criteria focused on resectable NSCLC patients with PD-L1 expression data.
- Outcomes assessed included event-free survival (EFS), overall survival (OS), major pathological response (MPR), and pathological complete response (pCR).
Main Results:
- nCIT significantly improved pCR, MPR, and EFS in NSCLC patients with PD-L1 <1% compared to nCT alone.
- Patients with PD-L1 ≥1% showed higher rates of pCR, MPR, and longer EFS with nCIT.
- Overall survival (OS) benefit was observed with nCIT only in patients with PD-L1 ≥1%, not in PD-L1 <1% group.
Conclusions:
- Neoadjuvant chemo-immunotherapy (nCIT) is recommended for resectable NSCLC patients with negative PD-L1 expression due to significant improvements in pathological response and EFS.
- The overall survival benefit of nCIT in PD-L1-negative NSCLC patients warrants further validation.
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