Table 2.
Studies used in indirect treatment comparison of progression-free survival.
| Study | Design | Treatment | Control | Number of patients | Population | Outcomes assessed | |||
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Control | TTP | PFS | OS | |||||
| van der Graaf et al. 2012 [12] |
Phase III RCT | Pazopanib 800 mg 1q1d | Placebo | 246 | 123 | Intermediate-/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 y | No | Yes IRC and INV |
Yes |
|
| |||||||||
| Demetri et al. 2009 [44] | Phase II RCT | Trabectedin 1.5 mg/m2 1q3w 24 h | Trabectedin 0.58 mg/m2 1q1w 3 h | 136 | 134 | Unresectable and/or metastatic liposarcoma or LMS, ECOG PS 0/1, ≤2 prior cytotoxic regimens, age 20–80 y | IRC and INV | IRC, but KM curve not reported |
Yes |
|
| |||||||||
| Garcia-Carbonero et al. 2005 [45] |
Phase II nonrandomized trial | Trabectedin 1.5 mg/m2 1q3w 24 h | 36 | Histologically confirmed recurrent or metastatic STS with disease progression despite prior CT with ≤2 prior regimens for advanced disease, ECOG PS ≤ 1, age ≥ 18 y | Yes | No | Yes | ||
|
| |||||||||
| le Cesne et al. 2005 [46] |
Phase II nonrandomized trial | Trabectedin 1.5 mg/m2 1q3w 24 h | 104 | Bidimensionally measurable metastatic or unresectable locoregional recurrent histologically proven advanced STS, ≥1 prior AC-based CT (±ifosfamide), PS ≤ 2, age < 75 y |
Yes | No | Yes | ||
|
| |||||||||
| Yovine et al. 2004 [47] |
Phase II nonrandomized trial | Trabectedin 1.5 mg/m2 1q3w 24 h | 54 | Advanced or metastatic, histologically proven STS, previous treatment with at least one line of either single-agent or combination CT, WHO PS ≤ 1, age ≥ 18 y | Yes | No | Yes | ||
|
| |||||||||
| van Oosterom et al. 2002 [43] |
Phase II RCT | Ifosfamide 5 g/m2 × 1q3w | Ifosfamide 3 g/m2 × 3q3w | 36 | 40 | Locally recurrent STS not amenable to treatment or metastatic STS, WHO PS 0–2, age 22–75 y | Yes | No | Yes |
|
| |||||||||
| Hensley et al. 2008 [48] |
Phase II nonrandomized trial | Gemcitabine 900 mg/m2 2q3w + DOC 100 mg/m2 1q3w | 48 | Women with advanced or recurrent uterine LMS progressed after 1 cytotoxic regimen, no prior therapy with gemcitabine or DOC, GOG PS 0–2 | Yes | No | Yes | ||
|
| |||||||||
| Pautier et al. 2012 [33] |
Phase II RCT | Gemcitabine 900 mg/m2 2q3w + DOC 100 mg/m2 1q3w | Gemcitabine 1,000 mg/m2 3q4w | 69 | 52 | Metastatic or unresectable LMS, PS ≤ 2, ≥1 prior AC-based regimen, age 41–80 y | No | Yes | Yes |
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.