Table 2.

Phase III clinical trials of recurrent ovarian cancer with quality-of-life measurement from 2003 to 2011.

Trial	QOL measure	Primary trial outcome	QOL outcome	Ref.
Interval secondary cytoreduction (GOG 152)	FACT-0	Interval cytoreduction provided no additional benefit	Baseline FACT-0 scores were significantly associated with OS but not PFS; less neurotoxicity in patients who did undergo cytoreduction	[8]
PLD and carboplatin compared with CT for platinum-sensitive ovarian cancer in late relapse	EORTC QLQ-C30 and -OV28	PLD and carboplatin showed superior PFS and better therapeutic index	Ongoing analysis of QOL	[14]
Nonplatinum topotecan combinations vs topotecan alone for recurrent ovarian cancer	EORTC QLQ-C30 and -OV28	Nonplatinum topotecan advantages do not provide survival advantage over topotecan alone	QOL did not change throughout the study and did not differ between treatment groups at baseline after the third cycle and after completion of the last cycle of chemotherapy	[15]
Gemcitabine vs PLD in progressive or recurrent ovarian cancer	EORTC QLQ-C30	No advantage of gemcitabine over PLD but should be considered in the spectrum of drugs	No statistically significant differences in QOL scores at baseline; however, QOL scores higher in first and second post- baseline QOL assessment; PLD patients had better scores in physical and emotional functions and in fatigue	[66]
Gemcitabine compared with PLD in platinum-resistant ovarian cancer	FACT-0	Gemcitabine may be an acceptable alternative to PLD	FACT-0 scores were not significant predictors of PFS; however, they were predictive of OS	[67]
Early vs delayed treatment of relapsed ovarian cancer	EORTC QLQ-C30	No evidence for survival benefit in early treatment based on CA-125	Median time-to-QOL deterioration shorter in early treatment group; significant disadvantages in role, emotional, social and fatigue subscales	[16]
CG vs carboplaltin in platinum- sensitive recurrent ovarian cancer	EORTC QLQ-C30 and -OV28	The addition of gemcitabine improved PFS and response rate	No statistically significant treatment differences for baseline scores between arms as well as for score changes from baseline to treatment discontinuation	[68]

CG: Carboplatin/gemcitabine; CT: Carboplatin/paclitaxel; EORTC: European Organization for Research and Treatment of Cancer: FACT-O: Functional Assessment of Cancer Therapy – Ovarian: OS: Overall survival: PFS: Progression-free survival: PLD: Pegylated liposomal doxorubicin: QLQ: Quality of Life Questionnaire: QOL: Quality of life.