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. Author manuscript; available in PMC: 2017 Sep 15.
Published in final edited form as: Clin Cancer Res. 2016 May 25;22(18):4585–4593. doi: 10.1158/1078-0432.CCR-15-3101

Table 3.

Comparison of Baseline PD-L1 Expression and CD8+ TILs in Patients with EGFR versus KRAS Mutations

EGFR-Mutant
(N=62)
KRAS-Mutant
(N=65)
P Value
PD-L1 Positive
  PD-L1+ (≥ 50%) 7 (11%) 11 (17%) 0.449
  PD-L1+ (≥5%) 10 (16%) 20 (31%) 0.062

CD8+ TILs (Immunohistochemistry; IHC)a
  0 17 (35%) 18 (32%) 0.159
  1+ 29 (60%) 26 (46%)
  2+ 2 (4.2%) 11 (20%)
  3+ 0 (0%) 1 (1.8%)

CD8+ TILs (Image-Based)b per mm2
  Median
  (Range)
185.1
(6.1–1161.9)
330.1
(8.5–2567.3)
0.011

Concurrent PD-L1 Expression & CD8+ TILs (IHC)
  PD-L1+ (≥ 50%) & High CD8+ TILs (grade 2–3) 1/48 (2.1%) 7/56 (12%) 0.066
  PD-L1+ (≥ 5%) & High CD8+ TILs (grade 2–3) 1/48 (2.1%) 11/56 (20%) 0.005

Concurrent PD-L1 Expression & CD8+ TILs (Image-Based)
  PD-L1+ (≥ 50%) & Highc CD8+ TILs per mm2 2/46 (4.3%) 10/56 (18%) 0.061
  PD-L1+ (≥ 5%) & Highc CD8+ TILs per mm2 2/46 (4.3%) 15/56 (27%) 0.003
a

Cytology specimens and those with no tissue on the slide were excluded from the evaluation of CD8+ tumor infiltrating lymphocytes (TILs).

b

Cytology and markedly fragmented biopsy specimens and those with no tissue on the slide were excluded from the evaluation of CD8+ TILs.

c

High CD8+ TILs defined as ≥ median in the pre-treatment control (KRAS-mutant) population (330.1 per mm2).

Slight differences in the number of specimens analyzed using immunohistochemistry versus quantitative CD8 analysis reflect differences in tissue adequacy for analysis.

Percentages may not equal 100% due to rounding.