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Table 1 Baseline demographics and disease characteristics of the 437 patients with advanced non-small cell lung cancer who were enrolled in the ALTER0303 trial

From: China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy

Characteristic

Placebo arm [cases (%)]

Anlotinib arm [cases (%)]

Total

143

294

Gender

 Male

97 (67.8)

188 (63.9)

 Female

46 (32.2)

106 (36.1)

Smoking status

 Never smoked

66 (46.2)

151 (51.4)

 Light ex-smoker

67 (46.9)

130 (44.2)

 Current smoker

10 (7.0)

13 (4.4)

Baseline ECOG PS

 0

22 (15.4)

59 (20.1)

 1

120 (83.9)

233 (79.3)

 2

1 (0.7)

2 (0.7)

Pathologic type

 Adenocarcinoma

108 (75.5)

228 (77.6)

 Squamous or adenosquamous cell carcinoma

33 (23.1)

53 (18.0)

 Other types

2 (1.4)

13 (4.4)

Clinical stage at screening

 IIIB

7 (4.9)

15 (5.1)

 IV

136 (95.1)

277 (94.2)

 Others

0

2 (0.7)

Number of metastatic site

 ≤ 3

81 (56.6)

171 (58.2)

 > 3

62 (43.4)

123 (41.8)

Surgery history

91 (63.6)

153 (52.0)

Pre-chemotherapy

 Two lines

78 (54.5)

167 (56.8)

 Three lines or more

65 (45.5)

123 (41.8)

 After first line

0

4 (1.4)

EGFR mutation statusa

 Wild-type

98 (68.5)

201 (68.4)

 Sensitive mutation

45 (31.5)

93 (31.6)

ALK status

 Positive

2 (1.4)

5 (1.7)

 Negative

136 (95.1)

277 (94.2)

 Unknown

5 (3.5)

12 (4.1)

Pre-TKI usea in EGFR mutation patient

42 (93%)

91 (98%)

  1. ECOG, Eastern Cooperative Oncology Group; PS, performance status; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; TKI, tyrosine kinase inhibitor
  2. aEGFR mutations include Exon 19 deletion and Exon 21 Leu858Arg. Pre-TKI use include: gefitinib, erlotinib, acotenib, afatinib and AZD9291