Patient characteristics
| Characteristic . | Thalidomide (N = 44) . | Lenalidomide (N = 41) . | Lenalidomide plus prednisone (N = 40) . | P . |
|---|---|---|---|---|
| Median age, y (range) | 65 (26-85) | 64 (42-83) | 64 (42-86) | .96 |
| Male, n (%) | 25 (57) | 22 (54) | 23 (58) | .93 |
| Previously untreated, n (%) | 25 (57) | 5 (12) | 10 (25) | .0001 |
| No. of prior treatments (range) | 0 (0-3) | 1 (0-6) | 1 (0-4) | .0009 |
| Median hemoglobin level (range), g/dL | 9.5 (5.8-15.1) | 9.8 (6.9-14.8) | 9.8 (6.6-15.4) | .12 |
| Median platelet count (range), × 109/L | 144 (14-572) | 203 (34-901) | 237 (8-1005) | .09 |
| Median WBC count (range), × 109/L | 10.2 (1.9-59.5) | 9 (2.4-45.4) | 8.6 (1.1-28.3) | .65 |
| Neutrophils, % (range) | 64 (28-90) | 66 (32-89) | 66 (10-89) | .55 |
| Splenomegaly, n (%) | 28 (64) | 20 (49) | 30 (75) | .25 |
| Median spleen size (range), cm | 15 (3-25) | 12 (3-30) | 11.5 (1-25) | .91 |
| Splenectomy, n (%) | 4 (9) | 7 (17) | 1 (2) | .08 |
| Cytogenetics | .75 | |||
| Diploid, n (%) | 24 (55) | 23 (56) | 20 (50) | |
| Abnormal, n (%) | 15 (34) | 15 (37) | 18 (45) | |
| 5 of 7 abnormalities, n (%) | 1 (2) | 2 (5) | 1 (2) | |
| ≥ 3 abnormalities, n (%) | 2 (5) | 2 (5) | 2 (5) | |
| IM + ND, n (%) | 5 (11) | 3 (7) | 2 (5) | |
| Myelofibrosis type | .96 | |||
| Primary, n (%) | 29 (71) | 29 (71) | 31 (78) | |
| After ET, n (%) | 7 (17) | 7 (17) | 5 (12) | |
| After PV, n (%) | 5 (12) | 5 (12) | 4 (10) | |
| ECOG Performance Status | .017 | |||
| 0, n (%) | 6 (14) | 16 (39) | 4 (10) | |
| 1, n (%) | 28 (64) | 22 (54) | 32 (80) | |
| 2, n (%) | 10 (22) | 3 (7) | 4 (10) | |
| DIPSS | .016 | |||
| Low, n (%) | 1 (2) | 2 (5) | 0 (0) | |
| Int-1, n (%) | 13 (30) | 21 (51) | 13 (32) | |
| Int-2, n (%) | 18 (41) | 15 (37) | 24 (60) | |
| High, n (%) | 12 (27) | 3 (7) | 3 (8) |
| Characteristic . | Thalidomide (N = 44) . | Lenalidomide (N = 41) . | Lenalidomide plus prednisone (N = 40) . | P . |
|---|---|---|---|---|
| Median age, y (range) | 65 (26-85) | 64 (42-83) | 64 (42-86) | .96 |
| Male, n (%) | 25 (57) | 22 (54) | 23 (58) | .93 |
| Previously untreated, n (%) | 25 (57) | 5 (12) | 10 (25) | .0001 |
| No. of prior treatments (range) | 0 (0-3) | 1 (0-6) | 1 (0-4) | .0009 |
| Median hemoglobin level (range), g/dL | 9.5 (5.8-15.1) | 9.8 (6.9-14.8) | 9.8 (6.6-15.4) | .12 |
| Median platelet count (range), × 109/L | 144 (14-572) | 203 (34-901) | 237 (8-1005) | .09 |
| Median WBC count (range), × 109/L | 10.2 (1.9-59.5) | 9 (2.4-45.4) | 8.6 (1.1-28.3) | .65 |
| Neutrophils, % (range) | 64 (28-90) | 66 (32-89) | 66 (10-89) | .55 |
| Splenomegaly, n (%) | 28 (64) | 20 (49) | 30 (75) | .25 |
| Median spleen size (range), cm | 15 (3-25) | 12 (3-30) | 11.5 (1-25) | .91 |
| Splenectomy, n (%) | 4 (9) | 7 (17) | 1 (2) | .08 |
| Cytogenetics | .75 | |||
| Diploid, n (%) | 24 (55) | 23 (56) | 20 (50) | |
| Abnormal, n (%) | 15 (34) | 15 (37) | 18 (45) | |
| 5 of 7 abnormalities, n (%) | 1 (2) | 2 (5) | 1 (2) | |
| ≥ 3 abnormalities, n (%) | 2 (5) | 2 (5) | 2 (5) | |
| IM + ND, n (%) | 5 (11) | 3 (7) | 2 (5) | |
| Myelofibrosis type | .96 | |||
| Primary, n (%) | 29 (71) | 29 (71) | 31 (78) | |
| After ET, n (%) | 7 (17) | 7 (17) | 5 (12) | |
| After PV, n (%) | 5 (12) | 5 (12) | 4 (10) | |
| ECOG Performance Status | .017 | |||
| 0, n (%) | 6 (14) | 16 (39) | 4 (10) | |
| 1, n (%) | 28 (64) | 22 (54) | 32 (80) | |
| 2, n (%) | 10 (22) | 3 (7) | 4 (10) | |
| DIPSS | .016 | |||
| Low, n (%) | 1 (2) | 2 (5) | 0 (0) | |
| Int-1, n (%) | 13 (30) | 21 (51) | 13 (32) | |
| Int-2, n (%) | 18 (41) | 15 (37) | 24 (60) | |
| High, n (%) | 12 (27) | 3 (7) | 3 (8) |
WBC indicates white blood cell; IM, insufficient metaphases; ND, not determined; ET, essential thrombocythemia; PV, polycythemia vera; ECOG, Eastern Cooperative Oncology Group; DIPSS, Dynamic International Prognostic Scoring System; Int-1, intermediate-1; and Int-2, intermediate-2.