Table I.
Comparison of basic patient characteristics and outcome between prophylactic and Hb-based ESA administration.
| A, Patient characteristics | ||||||
|---|---|---|---|---|---|---|
| Early disease | Advanced disease | |||||
| Characteristics | Hemoglobin based (n=144) | Prophylactic (n=140) | P-value | Hemoglobin based (n=159) | Prophylactic (n=140) | P-value |
| Age, years | 0.918 | 0.100 | ||||
| Mean (SD) | 59.9 (12.1) | 60.1 (12.0) | 62.3 (12.2) | 60.1 (12.6) | ||
| Median | 62.20 | 64.30 | 65.10 | 61.95 | ||
| Range | 29–78 | 29–78 | 27–83 | 20–84 | ||
| BSA | 0.274 | 0.237 | ||||
| Mean (SD) | 26.8 (4.3) | 26.3 (3.9) | 26.7 (5.3) | 25.9 (4.6) | ||
| Median | 27.10 | 26.20 | 25.80 | 25.80 | ||
| Range | 16–37 | 19–37 | 15–44 | 18–46 | ||
| Age (at median), N (%) | 0.402 | 0.091 | ||||
| <63 | 74 (51.4) | 65 (46.4) | 71 (44.6) | 87 (53.8) | ||
| ≥63 | 68 (47.2) | 73 (52.2) | 85 (53.5) | 71 (43.8) | ||
| Not reported | 2 (1.4) | 2 (1.4) | 3 (1.9) | 4 (2.4) | ||
| Concomitant CRT, N (%) | 0.185 | 0.159 | ||||
| No | 97 (67.4) | 85 (60.8) | 125 (78.6) | 111 (68.6) | ||
| Yes | 27 (18.8) | 35 (25.0) | 6 (3.8) | 11 (6.8) | ||
| Not reported | 20 (13.8) | 20 (14.2) | 28 (17.6) | 40 (24.6) | ||
| Gender, N (%) | 0.499 | 0.183 | ||||
| Male | 53 (36.8) | 57 (40.8) | 60 (37.8) | 73 (45.0) | ||
| Female | 91 (63.2) | 83 (59.2) | 99 (62.2) | 89 (55.0) | ||
| Malignacy, N (%) | 0.503 | 0.743 | ||||
| Breast | 39 (27.1) | 43 (30.8) | 26 (16.4) | 22 (13.6) | ||
| GynaecologicAL | 2 (1.4) | 0 (0.0) | 27 (17.0) | 31 (19.2) | ||
| Gastric | 8 (5.6) | 13 (9.2) | 9 (5.6) | 5 (3.0) | ||
| Colorectal | 79 (54.8) | 74 (52.8) | 38 (23.8) | 36 (22.2) | ||
| Pancreatic/hepatic | 2 (1.4) | 2 (1.4) | 7 (4.4) | 9 (5.6) | ||
| Prostate | 0 (0.0) | 0 (0.0) | 1 (0.6) | 0 (0.0) | ||
| Non-prostate GU | 8 (5.6) | 4 (2.8) | 25 (15.8) | 32 (19.8) | ||
| Lung | 5 (3.5) | 3 (2.2) | 20 (12.6) | 25 (15.4) | ||
| Not reported | 1 (0.6) | 1 (0.8) | 6 (3.8) | 2 (1.2) | ||
| PS score (WHO), N (%) | 0.715 | 0.464 | ||||
| 0 | 117 (81.2) | 113 (80.8) | 91 (57.2) | 100 (61.8) | ||
| 1–2–3 | 19 (13.2) | 22 (15.6) | 57 (35.8) | 51 (31.4) | ||
| Not reported | 8 (5.6) | 5 (3.6) | 11 (7.0) | 11 (6.8) | ||
| Transfusion history, N (%) | 0.350 | 0.524 | ||||
| No | 111 (77.0) | 100 (71.4) | 121 (76.2) | 129 (79.6) | ||
| Yes | 14 (9.8) | 18 (12.8) | 8 (5.0) | 6 (3.8) | ||
| Not reported | 19 (13.2) | 22 (15.8) | 30 (18.8) | 27 (16.6) | ||
| B, Outcome | ||||||
| Early disease | Advanced disease | |||||
| Characteristics | Hemoglobin-based | Prophylactic | P-value | Hemoglobin-based | Prophylactic | P-value |
| FU, months | ||||||
| Median (range) | 85.0 (0.2–111.9) | 86.6 (0.7–107.8) | 83.8 (0.3–94.3) | 86.3 (0.3–102.5) | ||
| OS, months | 0.6008a | 0.7216a | ||||
| Median (95% CI) | NYR (80.8-NYR) | NYR (87.9-NYR) | 13.4 (11.2–16.3) | 17.4 (13.8–21.8) | ||
| Event-free at 3 years (%) | 77.3 | 76.3 | 25.2 | 26.5 | ||
| Total Events | 57/137 (41.6%) | 50/131 (38.2%) | 125/148 (84.5%) | 136/154 (88.3%) | ||
| DFS, months | 0.9102a | |||||
| Median (95% CI) | NYR (71.8-NYR) | NYR (80.8-NYR) | – | – | ||
| Event-free at 3 years (%) | 65.7 | 64.7 | – | – | ||
| Total Events | 59/141 (41.8%) | 55/137 (40.1%) | – | – | ||
| PFS, months | 0.4760a | |||||
| Median (95% CI) | – | – | 8.0 (7.4–9.7) | 10.2 (8.9–13.3) | ||
| Event-free at 3 years (%) | – | – | 21.2 | 18.3 | ||
| Total Events | – | – | 119/157 (75.8%) | 125/159 (78.6%) | ||
a
Log-rank test P-value. ESA, erythropoiesis-stimulating agent; NYR, not yet reached; BSA, body surface area; SD, standard deviation; CRT, chemoradiotherapy; GU, genitourinary; PS, performance status; CI, confidence interval; WHO, World Health Organization; FU, follow-up; OS, overall survival; DFS, disease-free survival; PFS, progression-free survival.