Table 2 Treatment responses of the study patients
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 |