Introduction
Patients and methods
Study design and patients
Randomization and treatment
Assessments
Statistical analysis
Results
Patients
S-1 (n = 361) | Docetaxel (n = 359) | |
---|---|---|
Age, years (range) | 65 (23–85) | 64 (36–82) |
Histological type, n (%) | ||
Adenocarcinoma | 263 (72.9) | 270 (75.2) |
Squamous cell carcinoma | 67 (18.6) | 65 (18.1) |
Large cell carcinoma | 10 (2.8) | 3 (0.8) |
Others | 21 (5.8) | 21 (5.8) |
Number of previous treatments, n (%) | ||
1 | 233 (64.5) | 235 (65.5) |
2 | 101 (28.0) | 101 (28.1) |
3 | 27 (7.5) | 23 (6.4) |
EGFR status, n (%) | ||
Wild type | 222 (61.5) | 221 (61.6) |
Mutant | 75 (20.8) | 70 (19.5) |
Unknown | 64 (17.7) | 68 (18.9) |
EGFR-TKI treatment history, n (%) | ||
No | 281 (77.8) | 286 (79.7) |
Yes | 80 (22.2) | 73 (20.3) |
Efficacy
Safety and AEs
Number of patients (%) | S-1 (n = 358) | Docetaxel (n = 352) | ||
---|---|---|---|---|
All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
Hematologic toxicities | ||||
Leucopenia | 23 (6.4) | 6 (1.7) | 145 (41.2) | 113 (32.1) |
Neutropenia | 50 (14.0) | 24 (6.7) | 200 (56.8) | 190 (54.0) |
Febrile neutropenia | 4 (1.1) | 4 (1.1) | 53 (15.1) | 53 (15.1) |
Anemia | 35 (9.8) | 10 (2.8) | 22 (6.3) | 4 (1.1) |
Thrombocytopenia | 38 (10.6) | 6 (1.7) | 9 (2.6) | 0 (0.0) |
Non-hematologic toxicities | ||||
Stomatitis | 112 (31.3) | 12 (3.4) | 68 (19.3) | 4 (1.1) |
Nausea | 147 (41.1) | 5 (1.4) | 110 (31.3) | 6 (1.7) |
Vomiting | 61 (17.0) | 7 (2.0) | 44 (12.5) | 3 (0.9) |
Decreased appetite | 211 (58.9) | 35 (9.8) | 163 (46.3) | 12 (3.4) |
Diarrhea | 164 (45.8) | 30 (8.4) | 73 (20.7) | 3 (0.9) |
Constipation | 70 (19.6) | 3 (0.8) | 86 (24.4) | 1 (0.3) |
Maculopapular rash | 57 (15.9) | 5 (1.4) | 46 (13.1) | 1 (0.3) |
Skin hyperpigmentation | 123 (34.4) | – | 9 (2.6) | – |
Peripheral edema | 11 (3.0) | 0 (0.0) | 75 (21.3) | 3 (0.9) |
Pyrexia | 54 (15.0) | 0 (0.0) | 59 (16.8) | 0 (0.0) |
Weight loss | 50 (14.0) | 2 (0.6) | 18 (5.1) | 0 (0.0) |
Peripheral sensory neuropathy | 25 (7.0) | 1 (0.3) | 69 (19.6) | 3 (0.9) |
Cough | 21 (5.9) | 0 (0.0) | 28 (8.0) | 0 (0.0) |
Dyspnea | 14 (3.9) | 2 (0.6) | 22 (6.3) | 2 (0.6) |
Alopecia | 8 (2.2) | – | 205 (58.2) | – |