Table 2: Studies used in indirect treatment comparison of progression-free survival.

StudyDesignTreatmentControlNumber of patientsPopulationOutcomes assessed
TreatmentControlTTPPFSOS

van der Graaf et al.
2012 [12]
Phase III RCTPazopanib 800 mg 1q1dPlacebo246123Intermediate-/high-grade malignant STS excluding GIST and adipocytic subtypes, WHO PS 0/1, ≤4 prior systemic therapies for advanced disease and ≤2 combination regimens, age 18–83 yNoYes
IRC and INV
Yes

Demetri et al. 2009 [44]Phase II RCTTrabectedin 1.5 mg/m2 1q3w 24 hTrabectedin 0.58 mg/m2 1q1w 3 h136134Unresectable and/or metastatic liposarcoma or LMS, ECOG PS 0/1, ≤2 prior cytotoxic regimens, age 20–80 yIRC and INVIRC, but
KM curve not reported
Yes

Garcia-Carbonero
et al. 2005 [45]
Phase II nonrandomized trialTrabectedin 1.5 mg/m2 1q3w 24 h36Histologically confirmed recurrent or metastatic STS with disease progression despite prior CT with ≤2 prior regimens for advanced disease, ECOG PS ≤ 1, age ≥ 18 yYesNoYes

le Cesne et al. 2005
[46]
Phase II nonrandomized trialTrabectedin 1.5 mg/m2 1q3w 24 h104Bidimensionally measurable metastatic or unresectable locoregional recurrent histologically proven advanced STS, ≥1 prior AC-based CT (±ifosfamide), PS ≤ 2, age
< 75 y
YesNoYes

Yovine et al. 2004
[47]
Phase II nonrandomized trialTrabectedin 1.5 mg/m2 1q3w 24 h54Advanced or metastatic, histologically proven STS, previous treatment with at least one line of either single-agent or combination CT, WHO PS ≤ 1, age ≥ 18 yYesNoYes

van Oosterom
et al. 2002 [43]
Phase II RCTIfosfamide 5 g/m2  × 1q3wIfosfamide 3 g/m2  × 3q3w3640Locally recurrent STS not amenable to treatment or metastatic STS, WHO PS 0–2, age 22–75 yYesNoYes

Hensley et al. 2008
[48]
Phase II nonrandomized trialGemcitabine 900 mg/m2 2q3w + DOC 100 mg/m2 1q3w48Women with advanced or recurrent uterine LMS progressed after 1 cytotoxic regimen, no prior therapy with gemcitabine or DOC, GOG PS 0–2YesNoYes

Pautier et al. 2012
[33]
Phase II RCTGemcitabine 900 mg/m2 2q3w + DOC 100 mg/m2 1q3wGemcitabine 1,000 mg/m2 3q4w6952Metastatic or unresectable LMS, PS ≤ 2, ≥1 prior AC-based regimen, age 41–80 yNoYesYes

AC: anthracycline; CT: chemotherapy; DOC: docetaxel; ECOG: Eastern Cooperative Oncology Group; GIST: gastrointestinal stroma tumor; GOG: Gynecologic Oncology Group; INV: investigator; IRC: institutional review committee; KM: Kaplan-Meier; LMS: leiomyosarcoma; OS: overall survival; PFS: progression-free survival; PS: performance status; RCT: randomized clinical trial; STS: soft tissue sarcoma; TTP: time to progression; WHO: World Health Organization.