Table 3. Response and survival outcomes by trial interventions.
Platinum-based regimen
|
Number of drugs
|
|||||||
---|---|---|---|---|---|---|---|---|
Yes (N=216)
|
No (N=217)
|
2-Drugs (N=212)
|
3-Drugs (N=221)
|
|||||
No. | % | No. | % | No. | % | No. | % | |
Best overall response a | ||||||||
CR | 4 | 2 | 4 | 2 | 4 | 2 | 4 | 2 |
PR | 62 | 29 | 48 | 22 | 57 | 27 | 53 | 26 |
SD | 77 | 36 | 71 | 33 | 69 | 33 | 79 | 35 |
PD | 29 | 14 | 39 | 18 | 34 | 16 | 34 | 16 |
NE | 41 | 19 | 52 | 24 | 47 | 22 | 46 | 22 |
Adjusted percentage of CR+PR (95% CI) | 31% (25–37%) | 24% (19–30%) | 29% (23–35%) | 26% (21–33%) | ||||
Adjusted OR (95% CI), P-value | 0.72 (0.47–1.10), P=0.124 | 0.86 (0.56–1.32), P=0.487 | ||||||
PFS | ||||||||
Number of events | 201 | 213 | 201 | 213 | ||||
1-Year and 2-year adjusted probability | 19.7% and 7.6% | 12.9% and 3.9% | 15.8% and 5.3% | 16.5% and 5.7% | ||||
Adjusted median (95% CI), months | 6.4 (5.3–7.1) | 4.9 (4.4–5.8) | 5.6 (4.7–6.6) | 5.7 (4.8–6.7) | ||||
Adjusted HR (95% CI), P-value | 1.26 (1.04–1.53), P=0.020 | 0.98 (0.81–1.19), P=0.820 | ||||||
OS | ||||||||
Number of events | 190 | 209 | 195 | 204 | ||||
1-Year and 2-year adjusted probability | 47.9% and 20.7% | 40.6% and 14.5% | 44.8% and 17.9% | 43.8% and 17.0% | ||||
Adjusted median (95% CI), months | 11.3 (9.8–12.7) | 9.7 (8.7–10.8) | 10.4 (9.4–12.2) | 10.3 (9.2–11.8) | ||||
Adjusted HR (95% CI), P-value | 1.23 (1.01–1.49), P=0.044 | 1.03 (0.85–1.25), P=0.781 | ||||||
Abbreviations: CI=confidence interval; CR=complete response; HR=hazard ratio; NE=not evaluated; OR=odds ratio; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PR=partial response; SD=stable disease.
Six patients without measurable disease at randomisation were excluded from the analysis of best overall response.