Introduction
Methods
Study design and patients
Treatment
Assessments
Outcomes
Statistical analysis
Results
Trial | Japanese subpopulation | |
---|---|---|
Characteristic, n (%) | Nivolumab n = 136 | Chemotherapy n = 138 |
Age, median (range), years | 65.0 (41–82) | 68.0 (33–80) |
Age ≥ 65 years | 76 (55.9) | 98 (71.0) |
Sex, male | 113 (83.1) | 117 (84.8) |
ECOG PS 0 | 83 (61.0) | 88 (63.8) |
ECOG PS 1 | 53 (39.0) | 50 (36.2) |
Recurrent EC | 65 (47.8) | 70 (50.7) |
Number of organs with metastases (IWRS source) | ||
≤ 1 | 65 (47.8) | 66 (47.8) |
≥ 2 | 71 (52.2) | 72 (52.2) |
Prior surgery | 68 (50.0) | 69 (50.0) |
Prior radiotherapy | 99 (72.8) | 89 (64.5) |
PD-L1 expression | ||
≥ 10% | 41 (30.1) | 35 (25.4) |
≥ 5% | 46 (33.8) | 46 (33.3) |
≥ 1% | 66 (48.5) | 68 (49.3) |
Efficacy in the Japanese subpopulation
Overall survival
Progression-free survival
Response
n (%) | Japanese subpopulation (RES) | ||
---|---|---|---|
Nivolumab (n = 107) | Chemotherapy (n = 108) | OR (95% CI) | |
(a) Response and disease control | |||
ORR | 24 (22.4) | 24 (22.2) | 0.98 (0.52–1.87) |
CR | 0 | 2 (1.9) | |
PR | 24 (22.4) | 22 (20.4) | |
SD | 20 (18.7) | 48 (44.4) | |
PD | 58 (54.2) | 32 (29.6) | |
NE | 5 (4.7) | 4 (3.7) | |
DCR (CR + PR + SD) | 44 (41.1) | 72 (66.7) | 0.30 (0.17–0.55) |
n (%) | Nivolumab (n = 135) | Chemotherapy (n = 138) | ||||||
---|---|---|---|---|---|---|---|---|
Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | |
(b) Summary of treatment-related adverse events | ||||||||
All events | 69 (51) | 20 (15) | 3 (2) | 0 | 33 (24) | 66 (48) | 34 (25) | 2 (1) |
Serious events | 9 (7) | 12 (9) | 2 (1) | 0 | 5 (4) | 21 (15) | 5 (4) | 2 (1) |
Events leading to discontinuation | 9 (7) | 7 (5) | 0 | 0 | 5 (4) | 7 (5) | 2 (1) | 1 (< 1) |
Events leading to death | 0 | 2 (1) | 0 | 0 | 0 | 1 (< 1) | 0 | 2 (1) |
Events in ≥ 10% of treated patients in either group | ||||||||
Rash | 15 (11) | 0 | 0 | 0 | 18 (13) | 0 | 0 | 0 |
Hypothyroidism | 14 (10) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pyrexia | 10 (7) | 1 (< 1) | 0 | 0 | 15 (11) | 0 | 0 | 0 |
Diarrhoea | 8 (6) | 1 (< 1) | 0 | 0 | 12 (9) | 2 (1) | 0 | 0 |
Fatigue | 8 (6) | 0 | 0 | 0 | 21 (15) | 4 (3) | 0 | 0 |
Malaise | 8 (6) | 0 | 0 | 0 | 42 (30) | 0 | 0 | 0 |
Decreased appetite | 7 (5) | 0 | 0 | 0 | 32 (23) | 7 (5) | 0 | 0 |
Stomatitis | 4 (3) | 0 | 0 | 0 | 20 (14) | 1 (< 1) | 0 | 0 |
Dysgeusia | 3 (2) | 0 | 0 | 0 | 14 (10) | 0 | 0 | 0 |
Lymphocyte count decreased | 2 (1) | 2 (1) | 0 | 0 | 6 (4) | 9 (7) | 3 (2) | 0 |
Alopecia | 2 (1) | 0 | 0 | 0 | 82 (59) | 0 | 0 | 0 |
Arthralgia | 2 (1) | 0 | 0 | 0 | 16 (12) | 0 | 0 | 0 |
Constipation | 2 (1) | 0 | 0 | 0 | 14 (10) | 0 | 0 | 0 |
Neutrophil count decreased | 2 (1) | 0 | 0 | 0 | 13 (9) | 27 (20) | 26 (19) | 0 |
White blood cell count decreased | 1 (< 1) | 1 (< 1) | 0 | 0 | 18 (13) | 29 (21) | 13 (9) | 0 |
Nausea | 1 (< 1) | 0 | 0 | 0 | 22 (16) | 0 | 0 | 0 |
Neutropenia | 1 (< 1) | 0 | 0 | 0 | 6 (4) | 16 (12) | 6 (4) | 0 |
Peripheral sensory neuropathy | 1 (< 1) | 0 | 0 | 0 | 42 (30) | 1 (< 1) | 0 | 0 |
Anaemia | 0 | 3 (2) | 0 | 0 | 20 (14) | 16 (12) | 0 | 0 |
Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 14 (10) | 1 (< 1) | 0 |
Neuropathy peripheral | 0 | 0 | 0 | 0 | 15 (11) | 0 | 0 | 0 |