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Table 1 Summary of relevant randomised controlled trials included in the review

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

Interventions

Study

Study design

N*

Age median (range)

Males (%)

Median duration of follow-up (weeks)

Prior therapy for advanced disease

Performance status, n (%)

STS subtypes, (%)

Pazopanib 800 mg per day orally

PALETTE study 2011 [18, 19, 30]

R, DB, PC, MC-I, Phase III

246

56.0 (20.0-83.0)

40.0%

49.5 weeks

Anthracycline: 98.8%; ifosfamide: 66.7%

PS 0: 118 (48.0); PS 1: 128 (52.0)

Leiomyosarcoma: 44.3%; Synovial sarcoma: 10.2%; Others: 45.5%

Placebo

PALETTE study 2011 [18, 19, 30]

 

123

51.0 (18.0-78.0)

44.0%

45.3 weeks

Anthracycline: 98.4%; ifosfamide: 75.6%

PS 0: 60 (48.8); PS 1: 67 (51.2)

Leiomyosarcoma: 39.8%; Synovial sarcoma: 10.6%; Others: 49.6%

Trabectedin 1.5 mg/m2 24-hour infusion q3w

Demetri 2009 [22–26]~

R, OL, DR, MC-I, Phase II

136

53 (20–80)

32.4%

177.67 weeks

Anthracycline: 100%; anthracycline and ifosfamide: 99.3%

PS 0: 70 (51.5); PS 1: 66 (48.5)

Leiomyosarcoma: 61.5%; Liposarcoma: 25.6%; Others: 12.8%

Trabectedin 0.58 mg/m2 3-hour infusion qw

Demetri 2009 [22–26]~

 

134

54 (23–77)

41.8%

  

PS 0: 67 (50.0); PS 1: 67 (50.0)

Leiomyosarcoma: 55.5%; Liposarcoma: 37.8%; Others: 6.7%

Gemcitabine 1800 mg/m2 as a fixed dose infusion rate (10 mg/m2/minutes) + dacarbazine 500 mg/m2 q2w

GEIS study [20, 21]~

R, BU, AC, MC, Phase II

59

49 (18–78)

53.0%

62.83 weeks

Out of total eligible population of 109 patients 107 patients had received anthracycline and two patients had received ifosfamide

PS 0:22 (38.6); PS 1:30 (52.6); PS 2:5 (8.8)

Leiomyosarcoma: 28.1%; Liposarcoma/adipocytic sarcoma: 17.5%; Undifferentiated pleomorphic: 19.3%; Miscellaneous sarcoma: 24.6%; Synovial sarcoma: 10.5%

Dacarbazine 1200 mg/m2 q3w

GEIS study [20, 21]~

 

54

51 (25–73)

54.0%

60.67 weeks

 

PS 0: 17 (32.7); PS 1: 31 (51.6); PS 2: 4 (7.7)

Leiomyosarcoma: 30.8%; Liposarcoma/adipocytic sarcoma: 17.3%; Undifferentiated pleomorphic: 15.4%; Miscellaneous sarcoma: 26.9%; Synovial sarcoma: 9.6%

Gemcitabine 900 mg/m2 over 90 minutes, D1+D8 + docetaxel 100 mg/m2 over 60 min, D8 q21 days

Pautier 2009 [27, 31]~

R, BU, AC, MC, Phase II

84**

-

-

Unclear

Anthracycline: 100%

-

Leiomyosarcoma: 100%

Gemcitabine 1000 mg/m2 over 100 minutes, d1+d8+d15 q28 days

Pautier 2009 [27, 31]~

  

-

-

 

Anthracycline: 100%

-

Leiomyosarcoma: 100%

Sorafenib 400 mg twice daily orally

Pacey 2011 [28]

R, DB, PC, MC-I, Phase II

2

-

-

Unclear

Anthracycline and/or ifosfamide: 100%

-

Fibrosarcoma: 0.0%

Placebo

Pacey 2011 [28]

 

2

67 (62–72)

0

  

PS 0: 2 (100)

Leiomyosarcoma: 50.0%; Fibrosarcoma: 50.0%

PS 1: 0 (0.0)

Ifosfamide 5 g/m2/1 day given as 24-hour infusion; all cycles were repeated q3w

van Oosterom 2002 [29]

R, BU, DR, MC-I, Phase II

27

-

-

Unclear

Anthracycline: 100%

-

-

Ifosfamide 3 g/m2/day given over 4 hour on 3 consecutive days; all cycles were repeated q3w

van Oosterom 2002 [29]

 

31

-

-

 

Anthracycline: 100%

-

-

  1. AC: Active-controlled; BU: Blinding Unclear; DB: Double-blind; DR: Dose Ranging; ECOG: Eastern Cooperative Oncology Group; q3w: Every Three Weeks; q2w: Every Two weeks; qw: Every week; MFH: Malignant Fibrous Histiocytoma; min: Minutes; MC: Multicentre; MC-I: Multicentre International; OL: Open Label; PS: Performance Status; STS: Soft Tissue Sarcoma; *N represents number of patients randomised except for Pacey 2011 study and van Oosterom 2002 where N represents the patient population of interest with respect to prior treatment for advanced disease; **Represents total number of patients randomised in the study (number of patients randomised to each arm not reported); -Represents data not reported; ¶Represents data for the complete study population; ~Represents secondary reference.