Table 2 Patient and disease characteristics, hematologic and neuro-toxicity characteristics
Patient and disease characteristics | |||||
|---|---|---|---|---|---|
Total Number of patients recruited | Population for hematologic analysis | Population for outcome | |||
N=322 | All patients | Paclitaxel-Carboplatin | Carboplatin | N=266 | |
N=290 | N=240 | N=50 | |||
Age at diagnosis (years) | p=0.188* | p=0.218 § | p=0.128* | ||
Median | 60 | 59 | 59 | 56 | 59 |
Range | (20-85) | (20-85) | (21-82) | (20-85) | (21-84) |
Body mass index (BMI) | p=0.863* | p=0.063 § | p=0.055* | ||
Median | 25 | 25 | 24 | 26 | 24 |
Range | (16-39) | (16-39) | (16-39) | (18-37) | (16-39) |
Race | p=0.951* | p=0.517 § | p=0.520* | ||
Caucasian | 319 (99%) | 287 (99%) | 238 (99%) | 49 (98%) | 264 (99%) |
African | 1 (<1%) | 1 (<1%) | 0 (0%) | 1 (<1%) | 0 (0%) |
Asian | 1 (<1%) | 1 (<1%) | 1 (<1%) | 0 (0%) | 1 (<1%) |
Mixed: Asian-Indo-European | 1 (<1%) | 1 (<1%) | 1 (<1%) | 0 (0%) | 1 (<1%) |
Histologic subtype | p=0.532* | p<0.001 § | p<0.001* | ||
Serous | 258 (80%) | 230 (79%) | 209 (87%) | 21 (42%) | 231 (87%) |
Mucinous | 20 (6%) | 19 (7%) | 5 (2%) | 14 (28%) | 6 (2%) |
Endometrioid | 13 (4%) | 13 (4%) | 5 (2%) | 8 (16%) | 5 (2%) |
Clear cell | 17 (5%) | 14 (5%) | 8 (3%) | 6 (12%) | 11 (4%) |
Mixed cell | 8 (3%) | 8 (3%) | 7 (3%) | 1 (2%) | 7 (3%) |
Other epithelial ovarian cancer | 3 (1%) | 3 (1%) | 3 (1%) | 0 (0%) | 3 (1%) |
Non-epithelial | 3 (1%) | 3 (1%) | 3 (1%) | 0 (0%) | 3 (1%) |
FIGO stage | p=0.645* | p<0.001 § | p<0.001* | ||
I | 55 (15%) | 52 (18%) | 11 (5%) | 41 (82%) | 14 (5%) |
II | 17 (5%) | 15 (5%) | 13 (5%) | 2 (4%) | 15 (6%) |
III | 196 (61%) | 175 (60%) | 169 (70%) | 6 (12%) | 184 (69%) |
IV | 54 (17%) | 48 (17%) | 47 (20%) | 1 (2%) | 53 (20%) |
Tumor grade | p=0.235* | p<0.001 § | p<0.001* | ||
1 | 23 (7%) | 23 (8%) | 13(5%) | 10 (20%) | 13 (5%) |
2 | 50 (16%) | 45 (16%) | 30 (12%) | 15 (30%) | 35 (13%) |
3 | 249 (77%) | 222 (77%) | 197 (82%) | 25 (50%) | 218 (82%) |
Residual disease | p=0.120* | p<0.001 § | p=0.424* | ||
No macroscopic disease | 267 (83%) | 246 (85%) | 200 (83%) | 46 (92%) | 218 (82%) |
Macroscopic disease < 1cm | 7 (2%) | 6 (2%) | 6 (3%) | 0 (0%) | 7 (3%) |
Macroscopic disease > 1 cm | 8 (3%) | 6 (2%) | 6 (3%) | 0 (0%) | 8 (3%) |
Macroscopic disease, size unknown | 5 (2%) | 4 (1%) | 3 (1%) | 1 (2%) | 4 (2%) |
Macroscopic disease, inoperable | 35 (11%) | 28 (10%) | 25 (10%) | 3 (6%) | 29 (11%) |
Hematologic toxicity characteristics | |||||
All patients | Paclitaxel-Carboplatin | Carboplatin | |||
(N= 290) | (N=240) | (N=50) | |||
Number of cycles administered | p=0.266 § | ||||
<6 | 15 (5%) | 14 (6%) | 1 (2%) | ||
6 | 275 (95%) | 226 (94%) | 49 (98%) | ||
Grade anemia | p=0.118 § | ||||
0/1 | 62 (21%) | 51 (21%) | 11 (22%) | ||
2 | 171 (59%) | 136 (57%) | 35 (70%) | ||
3 | 51 (18%) | 48 (20%) | 3 (6%) | ||
4 | 6 (2%) | 5 (2%) | 1 (2%) | ||
Use of Erythropoiesis stimulating Agent (ESA) | p=0.073 § | ||||
No | 220 (76%) | 187 (78%) | 33 (66%) | ||
Yes | 70 (24%) | 53 (22%) | 17 (34%) | ||
Grade neutropenia | p<0.001 § | ||||
0/1 | 19 (7%) | 9 (4%) | 10 (20%) | ||
2 | 14 (5%) | 3 (1%) | 11 (22%) | ||
3 | 55 (19%) | 32 (13%) | 23 (46%) | ||
4 | 202 (70%) | 196 (82%) | 6 (12%) | ||
Febrile neutropenia | p=0.740 § | ||||
0 | 267 (92%) | 217 (90%) | 50 (100%) | ||
3 | 22 (8%) | 22 (9%) | 0 (0%) | ||
4 | 1 (<1%) | 1 (<1%) | 0 (0%) | ||
Use of colony stimulating factor (CSF) | p<0.001 § | ||||
No | 228 (79%) | 178 (74%) | 50 (100%) | ||
Yes | 62 (21%) | 62 (26%) | 0 (0%) | ||
Grade Trombocytopenia | p=0.089 § | ||||
0/1 | 180 (62%) | 156 (65%) | 24 (48%) | ||
2 | 53 (18%) | 41 (17%) | 12 (24%) | ||
3 | 43 (15%) | 31 (13%) | 12 (24%) | ||
4 | 14 (5%) | 12 (5%) | 2 (4%) | ||
Neurotoxicity characteristics | |||||
Population for neurotoxicity analysis (Paclitaxel-Carboplatin) (N=265) | Population excluded for neurotoxicity (Carboplatin) (N=56) | ||||
Number of cycles administered | p=0.596 # | ||||
<6 | 18 (7%) | 2 (4%) | |||
6 | 247 (93%) | 54 (96%) | |||
Grade peripheral sensory neuropathy | p<0.001 # | ||||
0 | 109 (41%) | 48 (86%) | |||
1 | 108 (41%) | 6 (11%) | |||
2 | 39 (15%) | 1 (2%) | |||
3 | 9 (3%) | 0 (0%) | |||
Grade motor neuropathy | p=0.461 # | ||||
0 | 56 (100%) | 254 (96%) | |||
1 | 0 (0%) | 10 (4%) | |||
2 | 0 (0%) | 1 (<1%) | |||
3 | 0 (0%) | 0 (0%) | |||
4 | 0 (0%) | 0 (0%) | |||