Table 1. Baseline demographic and clinical characteristics: (a) QW schedule, (b) Q3W and Q4W schedules.
|
(A) Darbepoetin alpha dose (μg kg−1 QW) |
(B) Treatment group – placebo or darbepoetin alpha |
|||||||
|---|---|---|---|---|---|---|---|---|
| 0.5 (N=6) | 1.0 (N=33) | 2.25 (N=33) | 4.5 (N=30) | Placebo (N=22) | 6.75 Q3W (N=21) | 6.75 Q4W (N=21) | 10.0 Q4W (N=22) | |
| Age (years) | ||||||||
| Mean (s.d.) | 53.2 (8.6) | 69.7 (13.5) | 70.2 (11.0) | 74.0 (9.1) | 68.8 (17.6) | 64.0 (16.6) | 70.5 (11.2) | 68.8 (9.1) |
| Sex | ||||||||
| (n/%) women | 5 (83) | 14 (42) | 17 (52) | 12 (40) | 13 (59) | 18 (86) | 13 (62) | 11 (50) |
| Disease (n/%) | ||||||||
| Genitourinary | 1 (17) | 12 (36) | 9 (27) | 12 (40) | 5 (23) | 2 (10) | 2 (10) | 3 (14) |
| Breast | 4 (67) | 9 (27) | 10 (30) | 7 (23) | 1 (5) | 8 (38) | 6 (29) | 4 (18) |
| Lymphoid malignancya | 0 (0) | 6 (18) | 8 (24) | 3 (10) | 4 (18) | 5 (24) | 6 (29) | 1 (5) |
| Gastrointestinal | 0 (0) | 1 (3) | 2 (6) | 4 (13) | 4 (18) | 2 (10) | 2 (10) | 4 (18) |
| Lung | 0 (0) | 1 (3) | 2 (6) | 2 (7) | 2 (9) | 2 (10) | 3 (14) | 5 (23) |
| Gynaecologic | 0 (0) | 1 (3) | 0 (0) | 1 (3) | 2 (9) | 1 (5) | 1 (5) | 4 (18) |
| Other | 1 (17) | 3 (9) | 2 (6) | 1 (3) | 4 (18) | 1 (5) | 1 (5) | 1 (5) |
| Disease stage (n/%)b | ||||||||
| Stages I–II | 0 (0) | 11 (33) | 4 (12) | 7 (23) | 6 (27) | 4 (19) | 6 (29) | 5 (23) |
| Stages III–IV | 6 (100) | 21 (64) | 27 (82) | 21 (70) | 15 (68) | 15 (71) | 12 (57) | 15 (68) |
| Unknown | 0 (0) | 1 (3) | 2 (6) | 2 (7) | 1 (5) | 2 (10) | 3 (14) | 2 (9) |
| Pretreatment chemotherapy or radiotherapy (n/%) | 5 (83) | 27 (82) | 28 (85) | 23 (77) | 18 (82) | 17 (81) | 17 (81) | 21 (95) |
| Haemoglobin (g dl−1) | ||||||||
| Mean (s.d.) | 9.60 (1.53) | 9.80 (0.91) | 9.62 (1.12) | 10.05 (0.94) | 9.84 (0.89) | 9.84 (1.38) | 10.20 (0.88) | 10.10 (0.80) |
| Endogenous EPO (mU ml−1) | ||||||||
| N | 6 | 33 | 33 | 28 | 21 | 20 | 21 | 21 |
| Median | 42.93 | 32.03 | 30.94 | 23.46 | 26.42 | 46.22 | 29.32 | 28.99 |
| Q1, Q3 | 24.08, 159.41 | 21.25, 54.06 | 18.80, 99.55 | 16.07, 34.60 | 16.31, 38.43 | 20.61, 61.17 | 17.66, 47.78 | 16.41, 45.98 |
| Ferritin (μg l−1) | ||||||||
| N | 6 | 33 | 33 | 29 | 22 | 21 | 21 | 22 |
| Median | 1164.0 | 472.0 | 206.0 | 149.0 | 133.5 | 92.0 | 113.0 | 169.5 |
| Q1, Q3 | 151.0, 2010.0 | 173.0, 942.0 | 97.0, 416.0 | 74.0, 402.0 | 36.0, 605.0 | 41.0, 292.0 | 50.0, 243.0 | 46.0, 465.0 |
a
Includes myelomas, chronic lymphocytic leukaemia, and non-Hodgkin's lymphoma.
b
Disease stage as defined by the investigator. QW=once weekly; Q3W=once every 3 weeks; Q4W=once every 4 weeks; N=number in cohort; s.d.=standard deviation; n=number in subset; EPO=erythropoietin; Q=quartile.