Introduction
Materials and methods
Study design
Patients
Treatment
Endpoints and study assessments
Statistical analysis
Results
Patients
Characteristic | TAS-114/S-1 (n = 64) | S-1 (n = 64) |
---|---|---|
Age (years), median | 65.5 | 64.0 |
Age group, n (%) | ||
< 65 years | 28 (43.8) | 33 (51.6) |
≥ 65 years | 36 (56.3) | 31 (48.4) |
Sex, n (%) | ||
Male | 41 (64.1) | 48 (75.0) |
Female | 23 (35.9) | 16 (25.0) |
Region, n (%) | ||
Western | 34 (53.1) | 34 (53.1) |
Asian | 30 (46.9) | 30 (46.9) |
ECOG PS, n (%) | ||
0 | 12 (18.8) | 17 (26.6) |
1 | 52 (81.3) | 47 (73.4) |
Histology subtype, n (%) | ||
Squamous cell carcinoma | 14 (21.9) | 14 (21.9) |
Adenocarcinoma | 48 (75.0) | 48 (75.0) |
Large cell carcinoma | 0 | 1 (1.6) |
Carcinoid tumor | 1 (1.6) | 0 |
Other | 1 (1.6) | 1 (1.6) |
EGFR mutation status, n (%) | ||
Positive | 7 (10.9) | 12 (18.8) |
Negative | 46 (71.9) | 38 (59.4) |
Unknown | 11 (17.2) | 14 (21.9) |
ALK translocation status, n (%) | ||
Positive | 2 (3.1) | 0 |
Negative | 44 (68.8) | 43 (67.2) |
Unknown | 18 (28.1) | 21 (32.8) |
Brain metastases, n (%) | 6 (9.4) | 7 (11.0) |
Number of prior systemic regimens, n (%) | ||
1 | 0 | 0 |
2 | 24 (37.5) | 19 (29.7) |
3 | 19 (29.7) | 17 (26.6) |
4 | 14 (21.9) | 15 (23.4) |
≥ 5 | 7 (10.9) | 13 (20.3) |
Main prior systemic anti-cancer agent, n (%) | ||
Platinum | 64 (100) | 64 (100) |
PD-1/PD-L1 antibodies | 46 (71.9) | 49 (76.6) |
Pemetrexed | 48 (75.0) | 47 (73.4) |
Docetaxel | 33 (51.6) | 38 (59.4) |
EGFR-TKI | 7 (11.0) | 11 (17.2) |
ALK-TKI | 2 (3.1) | 0 |
Treatment
Efficacy
ICR | INV | |||
---|---|---|---|---|
TAS-114/S-1 (n = 61) | S-1 (n = 58) | TAS-114/S-1 (n = 61) | S-1 (n = 59) | |
Overall response rate, % (95% CI) | 19.7 (10.6–31.8) | 10.3 (4.0–21.5) | 19.7 (10.6–31.8) | 10.2 (3.9–21.2) |
CR | 1 (1.6) | 0 | 0 | 0 |
PR | 11 (18.0) | 6 (10.3) | 12 (19.7) | 6 (10.2) |
SD | 37 (60.7) | 38 (65.5) | 36 (59.0) | 29 (49.2) |
PD | 12 (19.7) | 13 (22.4) | 13 (21.3) | 23 (39.0) |
Disease control rate (CR + PR + SD), % (95% CI) | 80.3 (68.2–89.4) | 75.9 (64.2–87.3) | 78.7 (66.3–88.1) | 59.3 (46.6–73.0) |
Safety
TAS-114/S-1 (n = 64) | S-1 (n = 63) | |||
---|---|---|---|---|
All Grades | ≥Grade 3 | All Grades | ≥Grade 3 | |
Event | n (%) | n (%) | n (%) | n (%) |
All | 60 (93.8) | 35 (54.7) | 57 (90.5) | 10 (15.9) |
Hematology | ||||
Anemia | 37 (57.8) | 14 (21.9) | 10 (15.9) | 0 |
White blood cell count decreased | 10 (15.6) | 2 (3.1) | 5 (7.9) | 0 |
Platelet count decreased | 8 (12.5) | 1 (1.6) | 6 (9.5) | 0 |
Neutrophil count decreased | 6 (9.4) | 2 (3.1) | 7 (11.1) | 1 (1.6) |
Non-hematology | ||||
Decreased appetite | 25 (39.1) | 3 (4.7) | 22 (34.9) | 1 (1.6) |
Nausea | 20 (31.3) | 0 | 20 (31.7) | 1 (1.6) |
Diarrhea | 18 (28.1) | 2 (3.1) | 12 (19.0) | 1 (1.6) |
Skin hyperpigmentation | 18 (28.1) | 0 | 11 (17.5) | 0 |
Maculo-papular rash | 18 (28.1) | 4 (6.3) | 2 (3.2) | 0 |
Asthenia | 17 (26.6) | 4 (6.3) | 9 (14.3) | 2 (3.2) |
Rash | 15 (23.4) | 5 (7.8) | 3 (4.8) | 0 |
Vomiting | 10 (15.6) | 0 | 11 (17.5) | 2 (3.2) |
Pruritus | 10 (15.6) | 0 | 7 (11.1) | 0 |
Stomatitis | 9 (14.1) | 1 (1.6) | 4 (6.3) | 0 |
Malaise | 8 (12.5) | 0 | 5 (7.9) | 0 |
Fatigue | 6 (9.4) | 1 (1.6) | 9 (14.3) | 1 (1.6) |
Dry skin | 9 (14.1) | 0 | 5 (7.9) | 0 |