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Table 1 RCT characteristics

From: Surrogacy of intermediate endpoints for overall survival in randomized controlled trials of first-line treatment for advanced soft tissue sarcoma in the pre- and post-pazopanib era: a meta-analytic evaluation

Characteristic

RCTs before 2012

(1974–2012)

RCTs after 2012

(2013–2017)

Total RCTs

 

No. of studies, n (%)

No. of patients, n (%)

No. of studies, n (%)

No. of patients, n (%)

No. of studies, n (%)

No. of patients, n (%)

 

18 (100.0)

4058 (100.0)

9 (100.0)

2098 (100.0)

27 (100.0)

6156 (100.0)

Trial phasea

 III

7 (38.9)

2061 (50.8)

4 (44.4)

1473 (70.2)

11 (40.7)

3534 (57.4)

 II

5 (27.8)

512 (12.6)

5 (55.6)

625 (29.8)

10 (37.0)

1137 (18.5)

 NS

6 (33.3)

1485 (36.6)

0 (0.0)

0 (0.0)

6 (22.2)

1485 (24.1)

Primary endpoint

 OS

0 (0.0)

0 (0.0)

2 (22.2)

1095 (52.2)

2 (7.4)

1095 (17.8)

 PFS

3 (16.7)

586 (14.4)

5 (55.6)

628 (29.9)

8 (29.6)

1214 (19.7)

 Other time-to-event

0 (0.0)

0 (0.0)

2 (22.2)

375 (17.9)

2 (7.4)

375 (6.1)

 RR

1 (5.6)

95 (2.3)

0 (0.0)

0 (0.0)

1 (3.7)

95 (1.5)

 NS

14 (77.8)

3377 (83.2)

0 (0.0)

0 (0.0)

14 (51.9)

3377 (54.9)

ITT analysis included

 No

17 (94.4)

3963 (97.7)

1 (11.1)

118 (5.6)

18 (66.7)

4081 (66.3)

 Yes

1 (5.6)

95 (2.3)

8 (88.9)

1980 (94.4)

9 (33.3)

2075 (33.7)

Post-protocol treatment described

 No

10 (55.6)

2885 (71.1)

3 (33.3)

374 (17.8)

13 (48.1)

3259 (52.9)

 Yes

8 (44.4)

1173 (28.9)

6 (66.7)

1724 (82.2)

14 (51.9)

2897 (47.1)

  1. aPhase II/III studies were counted as phase III studies
  2. Abbreviations: ITT, intention-to-treat; No., number; NS, not specified; OS, overall survival; PFS, progression-free survival; RCT, randomized controlled trial; RR, response rate