A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma

Table 1

Characteristics of included studies after protocol amendment.

Reference	Phase	Randomized,	Treatment	Patient group for safety		Median number of cycles (range)
van der Graaf et al., 2012 [11]	III	369	Pazopanib	Treated	239	Median treatment duration, 16.4 weeks (0–79 weeks)
			Placebo		123	Median treatment duration, 8.1 weeks (1–52 weeks)
Bramwell et al., 1986, 1987, 1993 [12–14]	II	171	Cyclophosphamide	Treated	29	2.5 (1–13)
			Ifosfamide		28	3 (1–15)
Demetri et al., 2009 [15]	II	270	Trabectedin 24 h IV every 3 weeks	Treated	130	5 (1–37)
			Trabectedin 3 h IV weekly for 3 of 4 weeks		130	2 (1–21)
García-Del-Muro et al., 2011 [16]	II	113	Dacarbazine	Treated and assessable	52	2 (1–10)
			Gemcitabine + dacarbazine		57	6 (2–12)
Pautier et al., 2012 [17]; Study 1: leiomyosarcoma	II	46	Gemcitabine	Treated	22	5
			Gemcitabine + docetaxel		24
Study 2: nonuterine leiomyosarcoma	II	44	Gemcitabine	Treated	22	4
			Gemcitabine + docetaxel		22

The article by Pautier et al. [17] presents the results of two independent phase II studies: one study in patients with uterine leiomyosarcoma and one in patients with nonuterine leiomyosarcoma. IV, intravenous.