Taxol

Clinical Pharmacology

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Clinical Pharmacology

Taxol

In both studies, patients treated with TAXOL (paclitaxel) in combination with cisplatin had significantly higher response rate, longer time to progression, and longer survival time compared with standard therapy. These differences were also significant for the subset of patients in the Intergroup study with non-optimally debulked disease, although the study was not fully powered for subset analyses (TABLES 2A and 2B). Kaplan- Meier survival curves for each study are shown in FIGURES 1 and 2.

TABLE 2A: EFFICACY IN THE PHASE 3 FIRST-LINE OVARIAN CARCINOMA STUDIES

	Intergroup (non-optimally debulked subset)			GOG-111
	T175/3^a c75 (n=218)		C750^a c75 (n=227)	T135/24^a c75 (n=196)		C750^a c75 (n=214)
•*Clinical Response^b*	(n=153)		(n=153)	(n=113)		(n=127)
—rate (percent)	58		43	62		48
—p-value^c		0.016			0.04
•*Time to Progression*
—median (months)	13.2		9.9	16.6		13.0
—p-value^c		0.0060			0.0008
—hazard ratio (HR)c		0.76			0.70
—95% CI^c		0.62–0.92			0.56–0.86
•*Survival*
—median (months)	29.5		21.9	35.5		24.2
—p-value^c		0.0057			0.0002
—hazard ratioc		0.73			0.64
—95% CI^c		0.58–0.91			0.50–0.81
^aTAXOL dose in mg/m²/infusion duration in hours; cyclophosphamide and cisplatin doses in mg/m². ^bAmong patients with measurable disease only. ^cUnstratified for the Intergroup Study, Stratified for Study GOG-111.

TABLE 2B: EFFICACY IN THE PHASE 3 FIRST-LINE OVARIAN CARCINOMA INTERGROUP STUDY

	T175/3^a c75 (n=342)		C750^a c75 (n=338)
•*Clinical Response^b*	(n=162)		(n=161)
—rate (percent)	59		45
—p-value^c		0.014
•*Time to Progression*
—median (months)	15.3		11.5
—p-value^c		0.0005
—hazard ratio^c		0.74
—95% CI^c		0.63–0.88
•*Survival*
—median (months)	35.6		25.9
—p-value^c		0.0016
—hazard ratio^c		0.73
—95% CI^c		0.60–0.89
^aTAXOL dose in mg/m²/infusion duration in hours; cyclophosphamide and cisplatin doses in mg/m². ^b Among patients with measurable disease only. ^c Unstratified.