Paclitaxel and Its Evolving Role in the Management of Ovarian Cancer

Table 2

Phase III studies on intravenous dose-dense paclitaxel.

Study	Regimen		Median PFS; (m)	Median; OS; (m)	Adverse effects	Comments
Katsumata et al., 2009 [21]; Katsumata et al., 2013 [22]; Harano et al., 2014 [23]	JGOG 3016	631			(i) Haematological toxicity higher in dose dense-21.1 versus 9.4%	Lower treatment completion in dose-dense 63 versus 48%; Frequent episodes of delay in dose-dense 76 versus 67%; Dose reductions in dose-dense 48 versus 35%; No significant difference in overall QOL between both groups ()
	Paclitaxel 80 mg/m^2 D1, 8, 15 + carboplatin AUC 6, 3 weekly versus; Paclitaxel 180 mg/m^2 + carboplatin AUC 6, 3 weekly	312	28.2	100.5
	Both given for 6–9 cycles	319	17.5	62.2
Chan et al., 2013 [24]	GOG-262				(i) Higher frequency of grade 3 anaemia (40.8 versus 15.7%, ),; grade 2 sensory neuropathy (25.9 versus 17.8%, ) but lower incidence of neutropenia (72 versus 83%, )
	Paclitaxel 80 mg/m^2 D1, 8, 15 + carboplatin AUC 6, 3 weekly versus; Paclitaxel 175 mg/m^2 + carboplatin AUC 6, 3 weekly	346	14.8	NR
	Both given for 6 cycles	346	14.3	NR
	Bevacizumab given optionally	112; (did not receive bevazicumab)	14.2 vs 10.3
Pignata et al., 2014 [25]	MITO-7	810			(i) Lower incidence of grade 3-4 neutropenia (42 versus 50%), febrile neutropenia (<1 versus 3%, ), thrombocytopenia (1 versus 7%, ), and other nonhaematological toxicities such as alopecia, vomiting, renal dysfunction, and neuropathy	Quality of life better in dose dense arm ()
	Paclitaxel 60 mg/m^2, weekly + carboplatin AUC 2, weekly versus; Paclitaxel 175 mg/m^2 + carboplatin AUC 6, 3 weekly	406; 404	18.3; 17.3

: number of patients, m: months, D: day PFS: progression free survival, OS: overall survival, NA: not available in paper or abstract, and NR: not yet reached.
Survival rate at 2 years.