Table 2.
Patient demographics, baseline clinical characteristics, tumor types, and chemotherapy history (mITT population)
| Moderately emetogenica | Highly emetogenica | |||||
|---|---|---|---|---|---|---|
| APF530 250 mg SC | APF530 500 mg SC | Palonosetron 0.25 mg IV | APF530 250 mg SC | APF530 500 mg SC | Palonosetron 0.25 mg IV | |
| N = 220 | N = 218 | N = 215 | N = 244 | N = 250 | N = 248 | |
| Age, years, mean (SD) | 54.8 (12.8) | 55.1 (12.8) | 57.3 (12.4) | 57.4 (13.3) | 56.7 (13.3) | 58.1 (13.6) |
| Sex, n (%) | ||||||
| Female | 193 (87.7) | 182 (83.5) | 179 (83.3) | 164 (67.2) | 157 (62.8) | 165 (66.5) |
| Race, n (%) | ||||||
| White | 125 (56.8) | 123 (56.4) | 143 (66.5) | 141 (57.8) | 156 (62.4) | 150 (60.5) |
| Asian | 67 (30.5) | 59 (27.1) | 48 (22.3) | 62 (25.4) | 68 (27.2) | 59 (23.8) |
| Other | 28 (12.7) | 36 (16.5) | 24 (11.2) | 41 (16.8) | 26 (10.4) | 39 (15.7) |
| ECOG PS, n (%) | ||||||
| 0–1 | 209 (95.0) | 214 (98.2) | 206 (95.8) | 234 (95.9) | 239 (95.6) | 237 (95.6) |
| 2 | 11 (5.0) | 4 (1.8) | 8 (3.7) | 10 (4.1) | 10 (4.0) | 11 (4.4) |
| Unknown | 0 | 0 | 1 (0.5) | 0 | 1 (0.4) | 0 |
| Hesketh classification, n (%) | ||||||
| 1–2 | 1 (0.5) | 2 (0.9) | 2 (0.9) | 0 | 0 | 1 (0.4) |
| 3 | 27 (12.3) | 36 (16.5) | 33 (15.3) | 1 (0.4) | 2 (0.8) | 0 |
| 4 | 190 (86.4) | 177 (81.2) | 177 (82.3) | 5 (2.0) | 4 (1.6) | 1 (0.4) |
| 5 | 2 (0.9) | 3 (1.4) | 2 (0.9) | 238 (97.5) | 244 (97.6) | 245 (98.8) |
| Unknown | 0 | 0 | 1 (0.5) | 0 | 1 (0.4) | 0 |
| Time since diagnosis, years, mean (SD) | n = 213 0.6 (1.7) | n = 212 1.0 (2.1) | n = 207 0.8 (1.8) | n = 236 0.7 (1.8) | n = 241 0.7 (1.7) | n = 235 0.5 (1.0) |
| Type of cancer, n (%) | ||||||
| Lung | 17 (7.7) | 11 (5.0) | 15 (7.0) | 70 (28.7) | 82 (32.8) | 63 (25.4) |
| Breast | 153 (69.5) | 142 (65.1) | 136 (63.3) | 66 (27.0) | 69 (27.6) | 63 (25.4) |
| Ovarian | 17 (7.7) | 17 (7.8) | 21 (9.8) | 34 (13.9) | 33 (13.2) | 39 (15.7) |
| Lymphoma | 4 (1.8) | 5 (2.3) | 1 (0.5) | 11 (4.5) | 11 (4.4) | 13 (5.2) |
| Prior chemotherapy, n (%) | ||||||
| Yes | 104 (47.3) | 109 (50.0) | 106 (49.3) | 143 (58.6) | 145 (58.0) | 138 (55.6) |
ECOG PS Eastern Cooperative Oncology Group performance status, IV intravenously, mITT modified intent to treat, SC subcutaneously, SD standard deviation
aAccording to Hesketh criteria