Efficacy and safety of pharmacological interventions in second- or later-line treatment of patients with advanced soft tissue sarcoma: a systematic review

Table 2 Summary of various efficacy/activity outcomes observed across randomised controlled trials

Intervention	Study	N	Progression free survival			Overall survival		Response rate				Progressive disease
			PFS rate, n (%)		PFS in months	1 year OS	OS in months	ORR	CR	PR	SD	PD
			3-month	6-month	median (95% CI)	n (%)	median (95% CI)	n (%)	n (%)	n (%)	n (%)	n (%)
Pazopanib	PALETTE study 2011/2	246	-	-	4.6†	-	12.6	11 (4.5) †	0 (0.0) †	11 (4.5) †	134 (54.5)†	66 (26.8) †
Placebo	PALETTE study 2011	123	-	-	1.6†	-	10.7	0 (0.0) †	0 (0.0) †	0 (0.0) †	33 (26.8) †	76 (61.8) †
Trabectedin 1.5 mg/m2 q3w	Demetri 2009	136	70 (51.5)	48 (35.5)	3.3† (2.1 - 4.6)	82 (60.0)	13.9 (12.5 - 18.6)	8 (5.6)†	-	-	-	-
Trabectedin 0.58 mg/m2 qw	Demetri 2009	134	60 (44.7)	37 (27.5)	2.3† (2.0 - 3.4)	67 (50.0)	11.8 (9.9 - 14.9)	2 (1.6)†	-	-	-	-
Dacarbazine	GEIS study	54	19 (35.2); p=0.001	-	2.0#	-	8.2§	2 (3.7)‡, p=0.16	-	2 (4.0)*#	10 (19.0)*#	-
Gemcitabine + Dacarbazine	GEIS study	59	32 (54.2); p=0.001	-	4.2#	-	16.8§	7 (11.9)‡, p=0.16	-	5 (9.0)* #	22 (38.0)*#	-
Sorafenib	Pacey 2011	2	-	-	-	-	-	-	-	-	-	0 (0.0) #
Placebo	Pacey 2011	2	-	-	-	-	-	-	-	0 (0.0) #	2 (100) #	0 (0.0) #
Gemcitabine	Pautier 2009	-	-	-	-	-	-	-	-	-	-	-
Gemcitabine + Docetaxel	Pautier 2009	-	-	-	-	-	-	-	-	-	-	-
Ifosfamide 5 g/m²/day	van Oosterom 2002	27	-	-	-	-	-	-	-	-	-	-
Ifosfamide 3 g/m²/day	van Oosterom 2002	31	-	-	-	-	-	-	-	-	-	-

CI: Confidence Interval; CR: Complete Response; INV: Investigator; IRC: Independent Review Committee; N: Number of evaluable Patients; n: Number with Outcome; ORR: Overall Response Rate; OS: Overall Survival; PFS: Progression-free Survival; PR: Partial Response; q3w: Every Three Weeks; qw: Every Week; SD: Stable Disease; *p=0.01; †Assessments were made by the independent review committee; ‡Assessments were made by the investigator; #Unclear if assessed by investigator or the Independent Review Committee; §Kaplan-Meier estimates reported; -Represents data not reported.

ISSN: 1471-2407