Table 1 Baseline characteristics: all path-evaluable patients and patients with or without pathologic evidence of LN involvement

From: Association between pathologic response and survival after neoadjuvant therapy in lung cancer

 

Path-evaluable populationa

All

With LN involvementb

Without LN involvementb

Nivolumab plus chemotherapy (n = 141)

Chemotherapy (n = 126)

Nivolumab plus chemotherapy (n = 68)

Chemotherapy (n = 74)

Nivolumab plus chemotherapy (n = 72)

Chemotherapy (n = 51)

Age, median (range), years

64 (46–82)

65 (34–83)

64 (47–76)

65 (34–84)

67 (49–80)

65 (46–82)

Male

69

71

72

72

65

69

Regionc

   North America

26

29

26

27

25

33

   Europe

20

10

15

12

25

6

   Asia

49

55

50

54

47

57

ECOG PS

   0

75

68

75

73

75

59

   1

25

32

25

27

25

41

Staged,e

   IB–II

37

39

26

32

46

47

   IIIA

63

61

74

68

54

53

Histology

   Squamous

47

52

46

51

47

51

   Nonsquamous

53

48

54

49

53

49

Smoking statusf

   Current/former

89

87

88

85

90

92

   Never

11

12

12

15

10

6

Tumor PD-L1 expressiong

   Not evaluable

8

8

10

12

6

2

   <1%

44

46

48

34

40

63

   ≥1%

48

46

41

54

54

35

   1–49%

29

29

16

35

42

20

   ≥50%

19

18

25

19

12

16

TMBh

   Not evaluable/not reportedi

50

48

56

51

46

43

   <12.3 mut/Mb

29

29

28

30

29

28

   ≥12.3 mut/Mb

21

23

16

19

25

29

  1. Data reported as % unless otherwise noted.
  2. ECOG PS, Eastern Cooperative Oncology Group performance status.
  3. aPath-evaluable: patients who underwent surgery and had pathologically evaluable samples.
  4. bAmong 179 patients randomized to both the nivolumab plus chemotherapy and chemotherapy groups, 149 and 135 received treatment and had definitive surgery, respectively, and 140 and 125 had path-evaluable samples from both PT and LN; LN involvement refers to pathologic evidence of LN disease at resection that had or had not fully regressed after neoadjuvant treatment (0% or >0% RVT in the resected LN).
  5. cRest of the world: 6% of patients in the nivolumab plus chemotherapy and chemotherapy arms (path-evaluable patient population), 9% and 7% of patients in the nivolumab plus chemotherapy and chemotherapy arms (with LN involvement), 3% and 4% of patients in the nivolumab plus chemotherapy and chemotherapy arms (without LN involvement).
  6. dDisease stage by case report form, per American Joint Committee on Cancer 7th edition.
  7. eStage IB, IIA, IIB disease: 6%, 16% and 15% of patients in the nivolumab plus chemotherapy arm and 3%, 21% and 14% in the chemotherapy arm, respectively (path-evaluable patient population); 3%, 16% and 7% of patients in the nivolumab plus chemotherapy arm and 3%, 24% and 5% in the chemotherapy arm, respectively (with LN involvement); 8%, 17% and 21% of patients in the nivolumab plus chemotherapy arm and 4%, 18% and 26% in the chemotherapy arm, respectively (without LN involvement).
  8. fSmoking status unknown: one patient in the chemotherapy arm (path-evaluable patient population); one patient in the chemotherapy arm (without LN involvement).
  9. gLevel of PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx assay (Dako); patients with tumor tissue that could not be assessed for PD-L1 (≤10% of concurrently randomized patients) were stratified to the PD-L1 expression <1% subgroup at randomization.
  10. hTMB was evaluated using the Illumina TSO500 assay. A 12.3-mut/Mb cutoff per TSO500 corresponds to 10 mut/Mb per the FoundationOne assay.
  11. iTMB was not analyzed for patients in China; these patients are included in the ‘not reported’ category.
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