Baseline dNLR is associated with ICI outcomes in advanced NSCLC; we previously reported that the early dNLR change during ICI was correlated to benefit in 292 advanced NSCLC patients. We aimed to confirm the impact of dNLR monitoring in a larger cohort.
1225 patients with advanced NSCLC treated with ICI (PD1/PDL1 +/- CTLA4) from 10 European/US centers were identified between Nov. 2012 and Mar. 2018. dNLR at baseline and before cycle 2 were retrospectively collected. dNLR was defined as neutrophils/(leucocytes-neutrophils). dNLR monitoring, combining dNLR at baseline (B) et before cycle 2 (C2) stratified the 3 groups: good (if dNLR≤3 remained low at B and C2), intermediate (if dNLR status increased ≤3 at B and >3 at C2 or decreased >3 at B and ≤3 at C2), poor (dNLR>3 at B and C2).
689 (56%) were males, 1058 (87%) smokers, 1066 (87%) with PS ≤ 1, with median age 65 years; 926 (76%) had nonsquamous; 108 were KRASm. PDL1 was known in 403/1225 (33%) and was ≥1% in 270 (67%). The median PFS and OS were 3.1m [95% CI 3-4] and 12m [10-13.7]. dNLR was >3 at B in 416 (34%) and before C2 in 417 pts (34%). At C2, the dNLR status changed in 267 pts, with 133 (11%) dNLR decreased and 134 (11%) dNLR increased. The median OS was 18.6m [16-21] for the good group when dNLR remained low (n = 675, 55%), 9.2m [8-13.9] for the intermediate when dNLR changed (n = 267, 22%) and 5m [4-6.3] for the poor group when dNLR remained high (dNLR>3, n = 283, 23%) (P < 0.0001). The median PFS was 5m [4-5.5] for the good group, 2.6m [2-4] for the intermediate and 2m [2-2.6] for the poor group (P < 0.0001). The poor group was associated with radiological disease progression (OR 2.22, CI 1.33-3.7, P = 0.002).
Baseline and 2nd cycle dNLR monitoring can early discriminate the benefit to ICI in advanced NSCLC patients on treatment. dNLR should be prospectively studied in clinical trials.
Clinical trial identification
Legal entity responsible for the study
Has not received any funding.
All authors have declared no conflicts of interest.Table: 1407P
|Multivariate analysis||Progression-free Survival (PFS)||Overall Survival (OS)|
|HR||95% CI||P value||HR||95% CI||P value|
|Age >65 years||0.98||0.79-1.21||0.847||1.15||0.89-1.47||0.292|
|Smoking Former/current smoker||0.56||0.38-0.84||0.005||0.49||0.49-1.23||0.294|
|N# line of ICI >2||0.88||0.70-1.09||0.232||0.93||0.72-1.20||0.581|
|N# metastatic sites >2||1.56||1.26-1.94||<0.0001||1.70||1.31-2.2||<0.0001|
|Performance status ≥2||1.73||.29-2.31||<0.0001||2.05||1.49-2.82||<0.0001|
|dNLR monitoring Intermediate Poor||1.24 1.62||0.94-1.62 1.22-2.13||0.003||1.23 2.34||0.89-1.70 1.72-3.18||<0.0001|