Table 2 Main outcomes

Overall survival (median)

25.9 (18.3 to 31.6) weeks vs 13.9 (11.1 to 18.6) weeks

25 (0.4 to 90.7) weeks vs 24.7 (1.3 to 101.3) weeks

32.3 (0.4-69.1) weeks vs 25.1 (0.6-65.1) weeks

33.0 (29.1 to 42.4) weeks vs 35.0 (31.0 to 37.4) weeks

Overall survival [hazard ratio]

0.61 (0.43 to 0.87)

1.04 (0.78 to 1.40)†

Risk ratio 0.90 (0.55 to 1.47)

0.98 (0.77 to 1.25)

Progression free survival

Time to progression

16.3 (12.9 to 20.0) weeks*

13.3 (0.4 to 55.1) weeks vs 12.3 (0.1 to 75.3) weeks

15 weeks vs 13 weeks

Response rate [risk ratio]

1.33 (0.79 to 2.25)$

1.56 (0.69 to 3.50)$

0.84 (0.53 to 1.31)$

Response rate

7%*

24.3% (16.2 to 32.4) vs18.3% (10.8 to 25.7); difference 6.0% (-6 to 18)

23% vs 15% difference 8.3% (-6.6% to 23.1%)

18.3% (12.2 to 24.4) vs 21.9% (15.3 to 28.5%) difference - 3.6% (-12.6% to 5.5%)

Complete response

0% vs 1%

Response duration

14.4 (9.4 to 50.1) weeks vs 15.3 (8.6 to 69.9) weeks

18 weeks vs 14 weeks

18.3 weeks vs 25.4 weeks

Stable disease

44%*

19.6% vs 11.5%; OR 1.87 (0.87 to 4.03)$

Quality of Life

Difference in rate of change EQ-5 D 0.15 (0.05 to 0.25) in favour of topotecan

FACT-L total score (change from baseline) -5.07 (-7.49 to -2.65) vs -5.67 (-8.05 to 3.28); difference 0.59 (-2.38 to 3.57)#