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Table 2 Patient and disease characteristics, hematologic and neuro-toxicity characteristics

From: Genetic variability in drug transport, metabolism or DNA repair affecting toxicity of chemotherapy in ovarian cancer

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%)
  1. *: p-value calculated against the total population (n = 322), §: p-value calculated against the population for hematologic analysis treated with taxol-carboplatin (n = 240), #: p-value calculated against the population for neurotoxicity treated with taxol-carboplatin (n = 265).