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Table 6 Efficacy/Activity outcomes across prospective non-randomised trials with sample size more than 10

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

Intervention

Study

N

Response rate n (%), IRC or unclear

PFS

TTP in months

OS

DOR in months

Progressive disease

   

ORR

CR

PR

MR

SD

n (%) or median (95% CI)

Median (range)

n (%) or median (range)

Median (range)

n (%), IRC or unclear

Brostallicin

Leahy 2007

40

2 (5.0%)~

0 (0.0 %)~

2 (5.0%) ~

-

20 (50.0 %)~

3 mo: 18 (45.0%)~; 6 mo: 9 (22.5%)~

2.9 months~ (1.4 - 3.7)

7.6 months (5.2 - 13.8)

-

17 (42.5%)~

Cisplatin

Thigpen 1986

19

1 (5.3%)

1 (5.3%)

0 (0.0%)

-

7 (36.8%)

-

-

-

9 months (N = 1)

11 (57.9%)

Cyclophosphamide

Bramwell 1993

18

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

-

-

-

-

-

-

Dacarbazine

Buesa 1991

44

8 (18.2%)

1 (2.3%)

7 (15.9%)

-

8 (18.2%)

-

-

-

-

28 (63.6%)

Docetaxel

Kostler 2001

25

4 (16.0%)

0 (0.0%)

4 (16.0%)

-

-

-

-

-

-

-

Docetaxel

Santoro 1999

36

1 (2.8%)#

0 (0.0%)

1 (2.8%)

-

10 (27.8%)

1.4 months (N = 37)

-

11.5 months (N = 37)

-

25 (69.4%)

Docetaxel

Van Hoesel 1994

21

-

0 (0.0%)~

-

-

-

-

-

-

-

-

Doxorubicin

Mouridsen 1987

23

2 (8.7%)~

-

-

-

-

-

-

-

-

-

Etoposide

Crawley 1997

16

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

8 (50.0%)

-

-

3.7 months (2.1 - 5.2)* (N = 17)

-

8 (50.0%)

Etoposide

Dombernowsky 1987

26

-

-

1 (3.8%)

-

-

-

-

-

19 months (N = 1)

-

Gefitinib

Ray-Coquard 2008

46

0 (0.0%)~

0 (0.0%)~

0 (0.0%)~

0 (0.0%)~

10 (21.7%)~

4 mo: 10 (21.7%)~; 6 mo: 3 (6.5%)~

1.4 months~

-

-

32 (69.6%)~

Gemcitabine

Ferraresi 2008

14

1 (7.1%)

0 (0.0%)

1 (7.1%)

-

3 (21.4%)

-

3.1 months (1.0 - 9.5)

11.8 months (1.0 - 54.5)

6.5 months (N = 1)

10 (71.4%)

Gemcitabine

Hartmann 2006

15

1 (6.7%)

0 (0.0%)

1 (6.7%)

-

7 (46.7%)

3 mo: 7 (46.7%); 6 mo: 2 (13.3%); 3.0 months (1.0 – 33.0)

3 months

6.0 months (3.0 - 33.0)

-

7 (46.7%)

Gemcitabine

Look 2004

33

7 (21.2%)

1 (3.0%)

6 (18.2%)

-

-

-

-

-

-

-

Gemcitabine

Spath-Schwalbe 2000

18

2 (11.1%)#

0 (0.0%)

2 (11.1%)

-

6 (33.3%)

-

-

12 mo: 5 (27.8%); 8 months

5.5 months (5.0 - 6.0) (N = 2)

9 (50.0%)

Ifosfamide

Antman 1985

26

8 (30.8%)#

0 (0.0%)

8 (30.8%)

3 (11.5%)

11 (42.3%)

-

-

-

(2.0 – 10.0+) (N = 11)

4 (15.4%)

Ifosfamide

Antman 1989

94

17 (18.1%)

2 (2.1%)

-

-

-

-

-

-

-

-

Ifosfamide

Babovic 1998

21

1 (4.8%)

1 (4.8%)

0 (0.0%)

-

4 (19.0%)

-

-

-

-

16 (76.2%)

Ifosfamide

Le Cesne 1995

36

12 (33.3%)

0 (0.0%)

12 (33.3%)

-

8 (22.2%)

-

-

20.0 months (6.0 – 91.0+) (N = 40)

8.0 months (6.0 – 13.0+) (N = 12)

16 (44.4%)

Ifosfamide

Nielsen 2000

Unclear

1 (7.7%)~

0 (0.0%) ~

1 (7.7%) ~

-

-

-

-

-

-

-

Ifosfamide

Palumbo 1997a

38

15 (39.5%)

1 (2.6%)

14 (36.8%)

-

17 (44.7%)

-

-

13.0 months (6.0 – 30.0+)

9.0 months (5.0 – 21.0+) (N = 15)

6 (15.8)

Ifosfamide

Patel 1997b

11

5 (45.5%)

0 (0.0%)

5 (45.5%)

-

2 (18.2%)

-

-

-

-

4 (36.4%)

Ifosfamide

Patel 1997b

32

6 (18.8%)

2 (6.3%)

4 (12.5%)

-

-

-

-

-

-

-

Ifosfamide

Scheulen 1983

16

10 (62.5%)

2 (12.5%)

3 (18.8%)

5 (31.3%)

1 (6.3%)

-

-

-

-

5 (31.3%)

Liposomal doxorubicin

Skubitz 2003

20

1 (5.0%)#

1 (5.0%)

0 (0.0%)

3 (15.0%)

3 (15.0%)

-

-

-

-

12 (60.0%)

Liposomal doxorubicin

Toma 2000

25

3 (12.0%)

0 (0.0%)

3 (12.0%)

2 (8.0%)

17 (68.0%)

-

-

12.0 months (6.0 – 16.0+)

(3.0 – 9.0+) (N = 3)

3 (12.0%)

Methotrexate

Buesa 1984

21

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

-

-

-

-

-

-

Paclitaxel

Palumbo 1997b

12

1 (8.3%)#

0 (0.0%)

1 (8.3%)

1 (8.3%)

6 (50.0%)

-

3 months

6 months

4 months (N = 1)

4 (33.3%)

Paclitaxel

Patel 1997a

12

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

-

-

-

-

 

-

Paclitaxel

Skubitz 1997

15

1 (6.7%)#

0

1 (6.7%)

-

-

-

-

-

12 months (N = 1)

-

Sorafenib

Bertuzzi 2010

61

-

-

9 (14.8%)

-

-

6 mo: 20 (32.7%)

-

6 mo: 41 (67.2%) (N = 61)

-

-

Sorafenib

Bertuzzi 2010

30$

2 (6.7%)#

1 (3.3%)

1 (3.3%)

-

18 (60.0%)

-

-

-

-

10 (33.3%)

Sorafenib

Pacey 2011

16

-

-

-

-

0 (0.0%)

-

-

-

-

-

Sunitinib

Decoster 2010

20

1 (5.0%)#

0 (0.0%)

1 (5.0%)

-

4 (20.0%)

-

-

-

8.3 months (N =1)

15 (75.0%)

Trabectedin

Garcia-Carbonero 2004

36

3 (8.3%)

1 (2.8%)

2 (5.6%)

2 (5.6%)

-

12 mo: 4 (11.1%)

1.7 months (1.3 - 4.4)*

6 mo: 27 (75.0%); 12 mo: 19 (52.7%); 12.1 months (8.1 - 26.5)*

9.0 months (4.0 – 20.0) (N = 3)

-

Trabectedin

Le Cesne 2005

104

8 (8.7%)~ (N = 92)

0 (0.0%) ~ (N = 92)

8 (8.7%) ~(N = 92)

-

44 (47.8%) ~† (N=92)

3 mo: 54 (52%)~; 6 mo: 30 (29%)~; 9 mo: 21 (20%)~; 12 mo: 18 (17%)~

3.4 months (2.5 - 4.1)* ~ (N = 99)

12 mo: 44 (42%); 9.1 months (7.8 - 12.1)*

11.6 months~ (N = 8)

35 (38.0%)~ (N = 92)

Trabectedin

Yovine 2004

27

2 (7.4%) ~

0 (0.0%) ~

2 (7.4%) ~

2 (7.4%) ~

4 (14.8%) ~

-

-

-

12.2 months~ (N = 2)

-

Biricodar + doxorubicin

Bramwell 2002

15

2 (13.3%) ~#

0 (0.0%) ~

2 (13.3%) ~

-

7 (46.7%) ~

3.1 months~ (N = 15)

-

-

-

6 (40.0%)~

Cisplatin + ifosfamide

Budd 1993

38

8 (21.0%)

3 (7.9%)

5 (13.2%)

-

-

-

-

11 months

-

-

Cisplatin + vinblastine

Keohan 1997

15

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

7 (46.7%)

-

2.0 months (0.7 - 12.0) (N =18)

-

-

8 (53.3%)

D + IL-2

Le Cesne 1999

12

2 (16.7%)

0 (0.0%)

2 (16.7%)

-

-

-

-

-

-

-

Epirubicin + lonidamine

Lopez 1995

24

2 (8.3%)

0 (0.0%)

2 (8.3%)

-

1 (4.2%)

-

-

14 months (N =24)

6.5 months (N =2)

-

Etoposide + ifosfamide

Saeter 1995

10

6 (60.0%)

0 (0.0%)

6 (60.0%)

-

-

-

-

-

-

-

Etoposide + ifosfamide

Skubitz 1993

15

6 (40.0%)

0 (0.0%)

6 (40.0%)

-

5 (33.3%)

-

-

-

(3.0 – 31.0+)~ (N = 6)

4 (26.7%)

Gemcitabine + dacarbazine

Buesa 2004

22

5 (26.3%)

(N = 19)

0 (0.0%) (N = 19)

5 (26.3%) (N = 19)

-

6 (31.6%) (N=19)

3 mo: 9 (40.9%) (N = 22); 6 mo: 6 (27.3%) (N = 22)

-

-

6.5 months (2.5 – 36.0) (N =5)

8 (42.1%) (N = 19)

Gemcitabine + dacarbazine

Losa 2007

23

1 (4.3%)

1 (4.3%)

0 (0.0%)

-

11 (47.8%)

3 mo: 12 (46.2%) (N = 26); 6 mo: 7 (26.9%) (N = 26)

3.6 months (N = 23)

8.5 months (N = 23)

-

11 (47.8%)

Gemcitabine + docetaxel

Hensley 2002

16

8 (50.0%) ~

1 (6.3%) ~

7 (43.8%) ~

-

-

-

-

-

-

-

Gemcitabine + docetaxel

Hensley 2008

48

13 (27.1%)

3 (6.3%)

10 (20.8%)

-

24 (50.0%)

3 mo: 35 (72.9%) (N = 48); 6 mo: 25 (52.1%) (N = 48); 6.7 months (0.7 – 27.0+) (N = 48)

-

14.7 months (0.8 - 50.9+) (N = 48)

9.0 months (3.9 - 24.5) (N = 13)

8 (16.7%)

Gemcitabine + docetaxel

Montalar 2008

12

1 (8.3%)#

0 (0.0%)

1 (8.3%)

-

4 (33.3%)

-

-

-

-

7 (58.3%)

Methotrexate + vincristine

Vaughn 1984

14

2 (14.3%)

0 (0.0%)

2 (14.3%)

-

3 (21.4%)

-

-

-

-

-

VAC + IE

Palumbo 1998

12

3 (25.0%)

0 (0.0%)

3 (25.0%)

-

4 (33.3%)

-

-

-

-

3 (25.0%)

C + VC + D + DTIC + IL-2

Gravis 2001

1

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

-

-

-

-

-

1 (100%)

D + I + DTIC + IL-2

Gravis 2001

9

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

1 (11.1%)

-

-

-

-

8 (88.9%)

D + IL-2

Gravis 2001

3

1 (33.3%)

0 (0.0%)

1 (33.3%)

-

-

-

-

-

2.0 months (N = 1)

2 (66.7%)

Carboplatin + etoposide

Holstein 1996

8

0 (0.0%)#

0 (0.0%)

0 (0.0%)

-

2 (25.0%)†

-

-

12.0 months (4.0 – 25.0)

-

6 (75.0%)

Dacarbazine

Holstein 1996

14

0 (0.0%)#

0 (0.0%)

0 (0.0%)

-

2 (14.3%) †

-

-

5.0 months (1.0 – 11.0)

-

12 (85.7%)

  1. CI: Confidence Interval; CR: Complete Response; C + VC + D + DTIC + IL-2: Cyclophosphamide + Vincristine + Doxorubicin + Dacarbazine + Interleukin-2; DOR: Duration of Response; D + IL-2: Doxorubicin + Interleukin-2; D + I + DTIC + IL-2: Doxorubicin + Ifosfamide + Dacarbazine + Interleukin-2; INV: Investigator; IRC: Independent Review Committee; mo: Months; MR: Minimal Response; mo: Months; N: Number of evaluable patients; n: Number with Outcome; ORR: Overall Response Rate; OS: Overall Survival; PFS: Progression-free Survival; PR: Partial Response; SD: Stable Disease; TTP: Time to progression; TTR: Time to Response; VAC + IE: Vincristine + Adriamycin + Cyclophosphamide + Ifosfamide + Etoposide; -Represents data not reported *95% Confidence Interval; ~Represents data assesssed by IRC; for other data it was unclear if assessed by investigator or the Independent Review Committee; #ORR calculated as CR + PR; †Represents no change; $Represents the subgroup of patients with both RECIST and CHOI evaluations for response.
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