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Taxol
Clinical Pharmacology
Taxol
Subset analyses. Subsets defined by variables of known prognostic importance in adjuvant breast carcinoma were examined, including number of positive lymph nodes, tumor size, hormone receptor status, and menopausal status. Such analyses must be interpreted with care, as the most secure finding is the overall study result. In general, a reduction in hazard similar to the overall reduction was seen with TAXOL (paclitaxel) for both disease-free and overall survival in all of the larger subsets with one exception; patients with receptor-positive tumors had a smaller reduction in hazard (HR=0.92) for disease-free survival with TAXOL than other groups. Results of subset analyses are shown in TABLE 4.
TABLE 4: SUBSET ANALYSESADJUVANT BREAST CARCINOMA STUDY
| Disease-Free Survival | Overall Survival | ||||
| Patient Subset | No. of Patients | No. of Recurrences | Hazard Ratio (95% CI) |
No. of Deaths | Hazard Ratio (95% CI) |
| • No. of Positive Nodes | |||||
| 13 | 1449 | 221 | 0.72 (0.550.94) |
107 | 0.76 (0.521.12) |
| 49 | 1310 | 274 | 0.78 (0.610.99) |
148 | 0.66 (0.470.91) |
| 10+ | 360 | 129 | 0.93 (0.661.31) |
87 | 0.90 (0.591.36) |
| •Tumor Size (cm) | |||||
| < 2 | 1096 | 153 | 0.79 (0.571.08) |
67 | 0.73 (0.451.18) |
| > 2 and ≤ 5 | 1611 | 358 | 0.79 (0.640.97) |
201 | 0.74 (0.560.98) |
| > 5 | 397 | 111 | 0.75 (0.511.08) |
72 | 0.73 (0.461.16) |
| • Menopausal Status | |||||
| Pre | 1929 | 374 | 0.83 (0.671.01) |
187 | 0.72 (0.540.97) |
| Post | 1183 | 250 | 0.73 (0.570.93) |
155 | 0.77 (0.561.06) |
| • Receptor Status | |||||
| Positivea | 2066 | 293 | 0.92 (0.731.16) |
126 | 0.83 (0.591.18) |
| Negative/ Unknownb | 1055 | 331 | 0.68 (0.550.85) |
216 | 0.71 (0.540.93) |
| a Positive for either estrogen
or progesterone receptors. b Negative or missing for both estrogen and progesterone receptors (both missing: n=15). |
|||||
Generic Name: Paclitaxel
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