Introduction
Patients and methods
Study design
Strategies of prophylaxis with G-CSF
Study endpoints
Statistical analysis
Results
Control group | Peg-group |
p value | |
---|---|---|---|
Total patients | 61 | 61 | |
Sex | |||
Male | 32 (52.4) | 31 (50.8) | 0.85 |
Female | 29 (47.6) | 30 (49.2) | |
Age, years | |||
Median (range) | 45.1 (31–76) | 45.4 (33–77) | 0.59 |
Histology [15] | |||
Follicular | 41 (67.2) | 42 (68.8) | 0.85 |
Marginal zone | 17 (27.9) | 15 (24.6) | 0.68 |
Small lymphocytic | 2 (3.3) | 2 (3.3) | 1.00 |
Lymphoplasmocytica
| 1 (1.6) | 2 (3.3) | 0.56 |
Stage | |||
II | 3 (4.9) | 2 (3.3) | 0.65 |
III | 12 (19.7) | 11 (18.0) | 0.81 |
IV | 46 (75.4) | 48 (78.7) | 0.66 |
B symptoms | 22 (36.1) | 19 (31.1) | 0.56 |
Bone marrow involved | 40 (65.6) | 42 (68.9) | 0.69 |
Extra-nodal involved sites ≥1 | 46 (75.4) | 45 (73.8) | 0.84 |
LDH >240 U/L | 22 (36.1) | 21 (34.4) | 0.85 |
Prognostic groups according to FLIPI | |||
Low risk (0–1 risk factor) | 5 (12.1) | 5 (11.9) | 0.96 |
Intermediate risk (2 risk factors) | 15 (36.6) | 13 (31.0) | 0.59 |
Poor risk (3–5 risk factors) | 21 (51.2) | 24 (57.1) | 0.58 |
Findings in the control group
Control group (N = 61) | Peg-group (N = 61) |
p value | |
---|---|---|---|
Overall chemotherapy disruption | 7 (11.5) | 1 (1.6) | 0.028 |
Time disruption | 3 (4.9) | 1 (1.6) | 0.31 |
Median days (range) | 16 (6–21) | 5a
| 0.04 |
Dose disruption | 4 (6.6) | – | 0.04 |
Percentage | 22.3 | – | <0.001 |
Characteristic | Control group (N = 61) | Peg-group (N = 61) |
p value |
---|---|---|---|
Neutropenic episodes without infectious symptoms | 20 (32.8) | 7 (11.5) | 0.04 |
Febrile neutropenia of unknown origin | 10 (16.4) | 2 (3.3) | 0.04 |
Febrile neutropenia with clinically documented infection | 17 (27.8) | 5 (8.2) | 0.005 |
Site/source of infection | |||
Moutha
| 7 (11.5) | 1 (1.6) | 0.03 |
Upper respiratory tract | 3 (4.9) | 1 (1.6) | 0.31 |
Lower respiratory tract | 5 (8.2) | 3 (4.9) | 0.46 |
Urinary tract | 2 | – | |
Radiological signs of infectionb
| 5 (8.2) | 3 (4.9) | 0.46 |
Febrile neutropenia with microbiologically documented infections | 7 (11.5) | 4 (6.6) | 0.34 |
Bacteremia | 2 (3.3) | – | 0.15 |
Gram-positive | 2 (3.3) | – | 0.15 |
Enterococcus spp. | 1 (1.6) | – | 0.31 |
Staphylococcus spp. | 1 (1.6) | – | 0.31 |
Gram-negative | – | – | 1.00 |
Positive sputum culture | 2 (3.3) | 1 (1.6) | 0.56 |
Gram-positive | 1 (1.6) | 1 (1.6) | 1.00 |
Staphylococcus spp. | 1 (1.6) | – | 0.31 |
Gram-negative | 1 (1.6) | – | 0.31 |
Pseudomonas spp. | 1 (1.6) | – | 0.31 |
Serum CMV DNA positivity | 3 (4.9) | 3 (4.9) | 1.00 |
Hospitalization required for FN complications | 5 (8.1) | 3 (4.9) | 0.46 |
Hospitalization days | |||
Median (range) | 18 (6–22) | 6 (1–21) | 0.04 |
ICU recovery | 2 (3.3) | – | 0.15 |