• Roger Sun, Champiat Stéphane S Drug Development Department, Gustave Roussy Cancer Campus, 94800 Villejuif, France., Laurent Dercle, Sandrine Aspeslagh, Eduardo Castanon, Elaine Johanna Limkin, Capucine Baldini, Sophie Postel-Vinay, Antoine Hollebecque, Christophe Massard, Samy Ammari, Eric Deutsch, Jean-Charles Soria, Aurélien Marabelle, and Charles Ferté.
• Drug Development Department, Gustave Roussy Cancer Campus, 94800 Villejuif, France; Department of Radiation Oncology, Gustave Roussy Cancer Campus, 94800 Villejuif, France.
• Eur. J. Cancer. 2017 Oct 1; 84: 202-211.

IntroductionA number of phase I immunotherapy trials for cancer patients incorporate the absolute lymphocyte count (ALC) as an inclusion criteria. This study aims to assess whether ALC is associated with a lack of response to anti-PD-1/PD-L1 in early clinical trials.MethodsAll consecutive patients treated with anti-PD-1/PD-L1 monotherapy in phase I trials in our institution between December 2011 and January 2014 were reviewed. Baseline ALC, neutrophil-to-lymphocyte ratio (NLR), Royal-Marsden Hospital (RMH) prognostic score, objective response rate (ORR) and disease control rate (DCR = SD + PR + CR, stable disease (SD), partial response (PR), complete response (CR)) defined by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 were retrieved.ResultsOut of a total of 167 patients, 48 (28.7%) and 8 patients (4.8%) had baseline ALCs of <1 G/l and <0.5 G/l, respectively. The RECIST change (%) was not correlated with ALC (G/l) (Spearman's rho = -0.06, P = 0.43). We did not observe any difference in terms of ORR (8.3% versus 15.1%, P = 0.32) or of DCR (58.3% versus 61.3%, P = 0.73) between patients with ALC <1 G/l versus >1 G/l. When using 0.5 G/l as ALC threshold, we did not find any difference either in ORR or in DCR. In a multivariate Cox regression analysis, baseline ALC was not associated with overall survival, whereas the RMH and the number of previous lines of treatment remained independent prognostic factors.ConclusionsBaseline ALC was not associated with response to anti-PD-1/PD-L1 in cancer patients enrolled in phase I trials. Patients should not be excluded from early phase clinical trials testing immune checkpoints blockers because of ALC.Copyright © 2017 Elsevier Ltd. All rights reserved.

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