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Taxol

Clinical Pharmacology
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Clinical Pharmacology

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 ANALYSES—ADJUVANT 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
  1–3 1449 221 0.72
(0.55–0.94)
107 0.76
(0.52–1.12)
  4–9 1310 274 0.78
(0.61–0.99)
148 0.66
(0.47–0.91)
  10+ 360 129 0.93
(0.66–1.31)
87 0.90
(0.59–1.36)
Tumor Size (cm)
   < 2 1096 153 0.79
(0.57–1.08)
67 0.73
(0.45–1.18)
   > 2 and ≤ 5 1611 358 0.79
(0.64–0.97)
201 0.74
(0.56–0.98)
   > 5 397 111 0.75
(0.51–1.08)
72 0.73
(0.46–1.16)
Menopausal Status
  Pre 1929 374 0.83
(0.67–1.01)
187 0.72
(0.54–0.97)
  Post 1183 250 0.73
(0.57–0.93)
155 0.77
(0.56–1.06)
Receptor Status
  Positivea 2066 293 0.92
(0.73–1.16)
126 0.83
(0.59–1.18)
  Negative/ Unknownb 1055 331 0.68
(0.55–0.85)
216 0.71
(0.54–0.93)
a Positive for either estrogen or progesterone receptors.
b Negative or missing for both estrogen and progesterone receptors (both missing: n=15).

Brand Name: Taxol
Generic Name: Paclitaxel
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