Introduction
Materials and methods
Patients
Treatment
Study design
Statistical consideration
Results
CONSORT diagram and characteristics of the ITT population
TMZ + RT (n = 63) | TMZ + IFNβ + RT (n = 59) | |
---|---|---|
Age, median (range) | 61 (22–75) | 61 (30–73) |
Gender | ||
Male | 38 | 35 |
Female | 25 | 24 |
ECOG PS | ||
0 | 16 | 12 |
1–3 | 47 | 47 |
Residual tumor after resection | ||
Absent | 31 | 33 |
Present | 32 | 26 |
IDH1/2 status | ||
No mutation | 57 | 58 |
Not examined | 6 | 1 |
Number of treatment course | TMZ + RT (n = 63) | TMZ + IFNβ + RT (n = 56) | n = 119 |
---|---|---|---|
0 | 8(12.7%) | 12(21.4%) | 20 |
1–12 | 39(61.9%) | 29(51.8%) | 68 |
13–31 | 16(25.4%) | 15(26.8%) | 31 |
RT/TMZ (n = 39) | RT/TMZ/IFNβ (n = 39) | |
---|---|---|
1. Same as protocol treatment | 11 | 14 |
TMZ | 9 | 5 |
TMZ + IFNβ | 2 | 9 |
2. Other chemotherapy (ACNU, Irinotecan, ICE, other TMZ regimens) | 1 | 6 |
3.SRS, SRT | 4 | 7 |
4. Surgery | 18 | 11 |
5. Others | 5 | 1 |
Bevacizumab | 3 | 0 |
Vaccine | 2 | 1 |
Overall and progression-free survival
Adverse events
(a) | TMZ + RT (N = 63) | TMZ + IFNβ + RT (N = 58) | ||||
---|---|---|---|---|---|---|
Grade 1–2 (%) | Grade 3 (%) | Grade 4 (%) | Grade 1–2 (%) | Grade 3 (%) | Grade 4 (%) | |
Hematological | ||||||
Neutropenia | 25 (39.7) | 4 (6.3) | 4 (6.3) | 32 (55.2) | 10 (17.2) | 2 (3.5) |
Lymphopenia | 24 (38.1) | 28 (44.4) | 6 (9.5) | 20 (34.5) | 30 (51.7) | 7 (12.1) |
Non-hematological | ||||||
Fever | 12 (19.0) | 0 | 0 | 18 (31.0) | 1 (1.7) | 0 |
Nausea | 18 (28.6) | 0 | 0 | 18 (31.0) | 2 (3.4) | 0 |
Vomiting | 7 (11.1) | 0 | 0 | 10 (17.2) | 1 (1.7) | 0 |
Anorexia | 26 (41.3) | 0 | 0 | 26 (44.8) | 5 (8.6) | 0 |
Febrile neutropenia | – | 1 (1.6) | 0 | – | 2 (3.4) | 0 |
ALT elevation | 35 (55.6) | 6 (9.5) | 0 | 31 (53.4) | 5 (8.6) | 1 (1.7) |
Hyponatremia | 13 (20.6) | 3 (4.8) | 0 | 15 (25.9) | 5 (8.6) | 0 |
Skin rash | 13 (20.6) | 1 (1.6) | 0 | 4 (6.9) | 0 | 0 |
(b) | TMZ + RT (N = 55) | TMZ + IFNβ + RT (N = 43)a | ||||
---|---|---|---|---|---|---|
Grade 1–2 (%) | Grade 3 (%) | Grade 4 (%) | Grade 1–2 (%) | Grade 3 (%) | Grade 4 (%) | |
Hematological | ||||||
Neutropenia | 31 (56.4) | 2 (3.6) | 0 | 21 (48.8) | 4 (9.3) | 0 |
Lymphopenia | 29 (52.7) | 17 (30.9) | 2 (3.6) | 22 (51.2) | 17 (39.5) | 1 (2.3) |
Non-hematological | ||||||
Fever | 3 (5.5) | 0 | 0 | 5 (11.6) | 0 | 0 |
Nausea | 14 (25.5) | 0 | 0 | 6 (14.0) | 0 | 0 |
Vomiting | 4 (7.3) | 1 (1.8) | 0 | 2 (4.7) | 0 | 0 |
Anorexia | 16 (29.1) | 2 (3.6) | 0 | 7 (16.3) | 0 | 0 |
Febrile neutropenia | – | 0 | 0 | – | 0 | 0 |
ALT elevation | 30 (54.5) | 1 (1.8) | 0 | 20 (46.5) | 0 | 0 |
Hyponatremia | 11 (20.0) | 0 | 0 | 7 (16.3) | 2 (4.7) | 0 |
Skin rash | 8 (14.5) | 0 | 0 | 8 (18.6) | 0 | 0 |