Highlights
- •A number of phase I immunotherapy trials exclude patients with low lymphocyte counts.
- •Lymphopenia <1 G/l was not associated with poor outcome in phase I cancer patients.
- •Lymphopenia should not be an exclusion criteria for anti-PD1/PD-L1 phase I trials.
Abstract
Introduction
A 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.
Methods
All 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.
Results
Out 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.
Conclusions
Baseline 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.
Keywords
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Article info
Publication history
Published online: August 18, 2017
Accepted:
July 21,
2017
Received in revised form:
July 18,
2017
Received:
June 2,
2017
Identification
Copyright
© 2017 Elsevier Ltd. All rights reserved.
