Table 2 Treatment responses of the study patients

From: Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial)

 

Intension-to-treat population

Per-protocol set

All, N = 45

Squamous cell carcinoma, N = 34

Adenocarcinoma, N = 10

Sarcomatoid carcinoma, N = 1

All, N = 41

Squamous cell carcinoma, N = 30

Adenocarcinoma, N = 10

Sarcomatoid carcinoma, N = 1

Pathologic responses, n/N (%, 95% CI)

 Pathological complete response

26/45 (57.8, 43.3–71.0)

22/34 (64.7, 47.9–78.5)

3/10 (30.0, 10.8–60.3)

1/1 (100.0, 20.6–100.0)

26/41 (63.4, 48.1–76.4)

22/30 (73.3, 55.6–85.8)

3/10 (30.0, 10.8–60.3)

1/1 (100.0, 20.6–100.0)

 Major pathological response

30/45 (66.7, 52.1–78.6)

26/34 (76.5, 60.0–87.6)

3/10 (30.0, 10.8–60.3)

1/1 (100.0, 20.6–100.0)

30/41 (73.2, 58.1–84.3)

26/30 (86.7, 70.3–94.7)

3/10 (30.0, 10.8–60.3)

1/1 (100.0, 20.6–100.0)

Clinical responses, n/N (%, 95% CI)

 CR

2

2

0

0

2

2

0

0

 PR

30

24

5

1

30

24

5

1

 ORR

32/45 (71.1, 55.7–83.6)

26/34 (76.5, 60.0–87.6)

5/10 (50.0, 23.7–76.3)

1/1 (100.0, 20.6–100.0)

32/41 (78.0, 63.3–88.0)

26/30 (86.7, 70.3–94.7)

5/10 (50.0, 23.7–76.3)

1/1 (100.0, 20.6–100.0)

 SD

12

8

4

0

8

4

4

0

 DCR

44/45 (97.8, 88.2–99.9)

34/34 (100.0, 89.6–100.0)

9/10 (90.0, 59.6–98.2)

1/1 (100.0, 20.6–100.0)

40/41 (97.6, 87.4–99.6)

30/30 (100, 88.7–100.0)

9/10 (90.0, 59.6–98.2)

1/1 (100.0, 20.6–100.0)

 PD

1

0

1

0

1

0

1

0

  1. Data are expressed as number (%) unless otherwise specified
  2. Pathological complete response is defined as the absence of residual tumour cells in resected primary tumour and lymph nodes [ypT0N0M0]) and major pathological response is defined as ≤10% viable tumour cells in resected primary tumour and lymph nodes as assessed by a pathologist. Clinical responses were assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1