Table 2.
Treatment and pharmacokinetic results of all enrolled patients and those evaluable for frozen glove efficacy
| Enrolled | Evaluable | |||||
|---|---|---|---|---|---|---|
| n | % | n | % | |||
| 23 | 16 | |||||
| Total docetaxel dose (mg/m2) | Median | 560 | 700 | |||
| Range | 80–1430 | 340–1430 | ||||
| Duration of docetaxel (months) | Median | 9.0 | 11.5 | |||
| Range | 0.6–24.3 | 5.3–24.3 | ||||
| < 5.0 | 7 | 30 | 0 | 0 | ||
| ≥ 5.0 | 16 | 70 | 16 | 100 | ||
| Combination chemotherapy | No | 3 | 13 | 1 | 6 | |
| Yes | 20 | 87 | 15 | 94 | ||
| Cytotoxic agent | Cyclophosphamide | 8 | 35 | 6 | 38 | |
| Capecitabine | 1 | 4 | 0 | 0 | ||
| Epirubicin | 2 | 9 | 2 | 13 | ||
| Hormonal agent | Anastrozole | 1 | 4 | 0 | 0 | |
| Letrozole | 7 | 30 | 5 | 31 | ||
| Exemestane | 3 | 13 | 3 | 19 | ||
| MPA | 1 | 4 | 0 | 0 | ||
| LH-RH analogue | 1 | 4 | 0 | 0 | ||
| Molecular target | Trastuzumab | 5 | 22 | 4 | 25 | |
| Pharmacokineticsa | AUC (mg*h/L) | Median | 1.73 | 1.76 | ||
| Range | 1.14–2.78 | 1.14–2.78 | ||||
| Clearance (L/h) | Median | 34.7 | 34.6 | |||
| Range | 22.8–52.2 | 23.0–51.9 | ||||
| Clearance/BSA (L/h/m2) | Median | 22.9 | 22.6 | |||
| Range | 14.5–35.6 | 14.5–35.6 | ||||
| C max (mg/mL) | Median | 1.57 | 1.57 | |||
| Range | 0.94–2.34 | 0.94–2.34 | ||||
| V ss (L) | Median | 12.5 | 12.6 | |||
| Range | 6.10–36.7 | 8.07–36.7 | ||||
aOne patient whose pharmacokinetic analysis was not carried out correctly was excluded from enrolled and evaluable cohorts
AUC area under the blood concentration time curve, BSA body surface area, C max maximum concentration, V ss volume in steady state, MPA medroxyprogesterone acetate, LH-RH luteinizing hormone releasing hormone